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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">ResProt</journal-id>
      <journal-id journal-id-type="nlm-ta">JMIR Res Protoc</journal-id>
      <journal-title>JMIR Research Protocols</journal-title>
      <issn pub-type="epub">1929-0748</issn>
      <publisher>
        <publisher-name>JMIR Publications</publisher-name>
        <publisher-loc>Toronto, Canada</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">v14i1e71849</article-id>
      <article-id pub-id-type="pmid">40343747</article-id>
      <article-id pub-id-type="doi">10.2196/71849</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Protocol</subject>
        </subj-group>
        <subj-group subj-group-type="article-type">
          <subject>Protocol</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Telenursing Health Education and Lifestyle Modification Among Patients With Diabetes in Bangladesh: Protocol for a Pilot Study With a Quasi-experimental Pre- and Postintervention Design</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <name>
            <surname>Sarvestan</surname>
            <given-names> Javad</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Zhang</surname>
            <given-names>Lei</given-names>
          </name>
        </contrib>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Maamor</surname>
            <given-names>Nur</given-names>
          </name>
        </contrib>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Tripathi</surname>
            <given-names>Raghvendra</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib id="contrib1" contrib-type="author" corresp="yes">
          <name name-style="western">
            <surname>Moriyama</surname>
            <given-names>Michiko</given-names>
          </name>
          <degrees>RN, MSN, PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <address>
            <institution/>
            <institution>Graduate School of Biomedical and Health Sciences</institution>
            <institution>Hiroshima University</institution>
            <addr-line>Kasumi 1-2-3 Minami-ku Hiroshima</addr-line>
            <addr-line>Hiroshima, 734-8553</addr-line>
            <country>Japan</country>
            <phone>81 82 257 5367</phone>
            <email>morimich@hiroshima-u.ac.jp</email>
          </address>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-9190-8705</ext-link>
        </contrib>
        <contrib id="contrib2" contrib-type="author">
          <name name-style="western">
            <surname>Huq</surname>
            <given-names>K A T M Ehsanul</given-names>
          </name>
          <degrees>MBBS, DTM, MMS, PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-7637-0759</ext-link>
        </contrib>
        <contrib id="contrib3" contrib-type="author">
          <name name-style="western">
            <surname>Mondol</surname>
            <given-names>Lucy</given-names>
          </name>
          <degrees>RN, BSN</degrees>
          <xref rid="aff2" ref-type="aff">2</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0009-0008-2498-6210</ext-link>
        </contrib>
        <contrib id="contrib4" contrib-type="author">
          <name name-style="western">
            <surname>Mita</surname>
            <given-names>Akhi Roy</given-names>
          </name>
          <degrees>RN, BSN, MSN</degrees>
          <xref rid="aff2" ref-type="aff">2</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0009-0005-8750-3309</ext-link>
        </contrib>
        <contrib id="contrib5" contrib-type="author">
          <name name-style="western">
            <surname>Nahar</surname>
            <given-names>Niru Shamsun</given-names>
          </name>
          <degrees>BSc, MSc, Dip (AN), Dip (N), Dip (M)</degrees>
          <xref rid="aff2" ref-type="aff">2</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0009-0000-1099-5871</ext-link>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution>Graduate School of Biomedical and Health Sciences</institution>
        <institution>Hiroshima University</institution>
        <addr-line>Hiroshima</addr-line>
        <country>Japan</country>
      </aff>
      <aff id="aff2">
        <label>2</label>
        <institution>Department of Nursing</institution>
        <institution>Grameen Caledonian College of Nursing</institution>
        <addr-line>Dhaka</addr-line>
        <country>Bangladesh</country>
      </aff>
      <author-notes>
        <corresp>Corresponding Author: Michiko Moriyama <email>morimich@hiroshima-u.ac.jp</email></corresp>
      </author-notes>
      <pub-date pub-type="collection">
        <year>2025</year>
      </pub-date>
      <pub-date pub-type="epub">
        <day>9</day>
        <month>5</month>
        <year>2025</year>
      </pub-date>
      <volume>14</volume>
      <elocation-id>e71849</elocation-id>
      <history>
        <date date-type="received">
          <day>29</day>
          <month>1</month>
          <year>2025</year>
        </date>
        <date date-type="rev-request">
          <day>26</day>
          <month>3</month>
          <year>2025</year>
        </date>
        <date date-type="rev-recd">
          <day>4</day>
          <month>4</month>
          <year>2025</year>
        </date>
        <date date-type="accepted">
          <day>5</day>
          <month>4</month>
          <year>2025</year>
        </date>
      </history>
      <copyright-statement>©Michiko Moriyama, K A T M Ehsanul Huq, Lucy Mondol, Akhi Roy Mita, Niru Shamsun Nahar. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.05.2025.</copyright-statement>
      <copyright-year>2025</copyright-year>
      <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/">
        <p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.</p>
      </license>
      <self-uri xlink:href="https://www.researchprotocols.org/2025/1/e71849" xlink:type="simple"/>
      <abstract>
        <sec sec-type="background">
          <title>Background</title>
          <p>The global burden of chronic diseases is increasing and becoming a public health issue throughout the world. The use of telenursing is increasing significantly during and after the COVID-19 pandemic to treat and prevent chronic diseases. Telenursing is growing in many countries to reduce health care costs, increase the number of aging and chronically ill populations, and increase health care coverage to distant, rural, small, or sporadically populated regions. Among its many benefits, telenursing may help to solve increasing shortages of nurses, reduce distances, save travel time, and keep patients out of the hospital.</p>
        </sec>
        <sec sec-type="objective">
          <title>Objective</title>
          <p>The objective of this study is to apply the self-management telenursing program and telenursing system developed by the researchers to Bangladesh and to evaluate its feasibility and efficacy (improved diabetes control in participants).</p>
        </sec>
        <sec sec-type="methods">
          <title>Methods</title>
          <p>This is a pilot, quasi-experimental pre- and post-intervention study. Diabetes patients who will attend the Grameen Primary Health Centers (PHCs) in Bangladesh will be enrolled between September 2024 and August 2025. We include patients who have been diagnosed with type 2 diabetes, both sexes, ages 18-75 years old, all types of treatment, willing to participate and give us consent. We exclude patients who have been diagnosed with gestational diabetes, diabetes as a secondary cause, complication of chronic kidney disease (CKD) stage 5, Hemoglobin A1c (HbA<sub>1c</sub>) is less than 7% for the past 1 year with CKD stage 1 or 2, no complications or complications with good control, having enough knowledge (had education before) and implemented good practice regarding diabetes management assessed by the research nurses, and disabled persons who need other person’s support for daily living. The sample size was calculated and found 70. Written informed consent will be obtained from all the participants. The study protocol got approval from the National Research Ethics Committee of the Bangladesh Medical Research Council (BMRC/NREC/2022-2025/336) on September 08, 2024. The outcome of this study is to evaluate the effects of telenursing intervention by controlling HbA<sub>1c</sub>.</p>
        </sec>
        <sec sec-type="results">
          <title>Results</title>
          <p>The project was funded in 2024. The enrollment of the participants started on October 26, 2024, and the required sample (n=70) enrollment was completed in February 2025. Data analysis will be started after completion of data collection and results will be expected to be submitted for publication in 2026.</p>
        </sec>
        <sec sec-type="conclusions">
          <title>Conclusions</title>
          <p>Diabetic patients will acquire disease-specific management skills. Setting and monitoring goals ensures the continuation of the desired behavior and gives the patients control over their lifestyle. After developing self-management skills, patients assess their lab data and lifestyles including diet, and understand their condition so that they can work with their physiological data by acquiring knowledge of both the disease and self-care. By making self-supported decisions, the patients will be able to manage their diet, exercise, and medication.</p>
        </sec>
        <sec sec-type="Trial Registration">
          <title>Trial Registration</title>
          <p>ClinicalTrials.gov NCT06632652; https://clinicaltrials.gov/study/NCT06632652</p>
        </sec>
        <sec sec-type="registered-report">
          <title>International Registered Report Identifier (IRRID)</title>
          <p>DERR1-10.2196/71849</p>
        </sec>
      </abstract>
      <kwd-group>
        <kwd>telenursing</kwd>
        <kwd>health education</kwd>
        <kwd>lifestyle modification</kwd>
        <kwd>diabetic patients</kwd>
        <kwd>Bangladesh</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec sec-type="introduction">
      <title>Introduction</title>
      <sec>
        <title>Background</title>
        <p>The global burden of noncommunicable diseases (NCDs) is increasing and becoming a public health issue throughout the world [<xref ref-type="bibr" rid="ref1">1</xref>]. Globally, diabetes caused 1.6 million deaths and 47% of all deaths before the age of 70 years in 2021. Diabetes increases the risk of death from kidney and cardiovascular diseases [<xref ref-type="bibr" rid="ref2">2</xref>]. The prevalence of diabetes has been increasing over the last few decades in all countries and is considered a global epidemic [<xref ref-type="bibr" rid="ref3">3</xref>], more quickly in low- and middle-income (LMICs) countries than in high-income countries. Moreover, diabetic treatment coverage was the lowest in the low- and middle-income range in 2022 [<xref ref-type="bibr" rid="ref4">4</xref>]. It is alarming that an estimated half of the global people (49.7%) living with diabetes remain undiagnosed [<xref ref-type="bibr" rid="ref5">5</xref>]. Diabetes has acute complications including ketoacidosis, hypoglycemia, or hyperglycemia. Chronic complications are macroangiopathy, retinopathy, nephropathy, neuropathy, and diabetic foot. Patients with diabetes are vulnerable to infections, myopathy, osteoporosis, arthropathies, and liver damage [<xref ref-type="bibr" rid="ref6">6</xref>]. Patients with diabetes may be able to prevent or delay diabetic health problems by maintaining a healthy lifestyle, taking medicine regularly, and controlling blood glucose levels [<xref ref-type="bibr" rid="ref7">7</xref>].</p>
        <p>The use of telenursing is increasing significantly during and after the COVID-19 pandemic to treat and prevent chronic diseases [<xref ref-type="bibr" rid="ref8">8</xref>]. As a field, it is part of telemedicine and has many points of contact with other medical and nonmedical applications, such as telediagnosis, teleconsultation, and telemonitoring. The field, however, is still being developed as the information on telenursing is not comprehensive enough [<xref ref-type="bibr" rid="ref9">9</xref>].</p>
        <p>Telenursing has been adopted by many developed and developing countries. It reduces health care costs and increases the coverage of health care to outreach, rural, small, or sporadically populated regions [<xref ref-type="bibr" rid="ref10">10</xref>]. It is useful for the increasing number of aging and chronically ill populations [<xref ref-type="bibr" rid="ref11">11</xref>]. Among its many benefits, telenursing may help solve increasing shortages of nurses [<xref ref-type="bibr" rid="ref12">12</xref>]; to reduce distances and save travel time and keep patients out of hospital [<xref ref-type="bibr" rid="ref10">10</xref>]. A greater degree of job satisfaction has been registered among telenurses [<xref ref-type="bibr" rid="ref13">13</xref>]. Continuous glucose monitoring (CGM) in patients with diabetes by integrating diagnostic devices for 24-hour real-time data transmission [<xref ref-type="bibr" rid="ref14">14</xref>] and IBM Watson Health for personalized lifestyle optimization can help to identify and prevent the early appearance of diseases. It allows rural patients to receive personalized, high-quality care and improves health care access and outcomes [<xref ref-type="bibr" rid="ref15">15</xref>].</p>
      </sec>
      <sec>
        <title>Diabetes in Bangladesh</title>
        <p>The prevalence of diabetes was 9.2% (male: 8.8%, female: 9.6%) and prediabetes was 13.3% (male: 13%, female: 13.6%) in 2017. Among the patients, only 30.4% had controlled diabetes, 35.2% took treatment regularly and 61.5% were not aware of their diabetic condition. The factors related to getting diabetes were increasing age, overweight, and hypertension. The proportional mortality was 3% from diabetes of total death in all ages. In Bangladesh, 17% population was overweight (male: 14.4%, female: 19.6%), 3.3% were obese (male: 2%, female: 4.6%), and 25.1% had physical inactivity (male: 9.2%, female: 41.3%), those are the related risk factors for diabetes [<xref ref-type="bibr" rid="ref16">16</xref>]. For the national response to diabetes, Bangladesh has an operational policy, strategy, and action plan for controlling diabetes and reducing physical inactivity, but not for reducing overweight and obesity. There are evidence-based national diabetes guidelines available, but not fully implemented. There are no set standard criteria for referral of patients from primary care to higher levels of care. In the primary care facilities, there are only blood glucose measurements and urine strips for glucose and ketone measurements generally available, but no facilities for insulin, metformin, sulphonylurea, oral glucose tolerance test, hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) test, dilated fundus examination, retinal photocoagulation, foot vibration perception by tuning fork, renal replacement therapy by dialysis, foot vascular status by Doppler, renal replacement therapy by transplantation in 2016 [<xref ref-type="bibr" rid="ref17">17</xref>].</p>
        <p>As there are no standard criteria for referring patients from primary care to a higher level of care, we will facilitate the patients to acquire self-management skills to understand the risk factors for diabetic complications and seek treatment in referral hospitals as necessary. They can attend referral hospitals to prevent diabetic complications by doing HbA<sub>1c</sub> tests, dilated fundus examinations, retinal photocoagulation, foot vibration perception by tuning fork, renal replacement therapy by dialysis and transplantation, and also foot vascular status by Doppler.</p>
      </sec>
      <sec>
        <title>Study Objectives</title>
        <sec>
          <title>General Objective</title>
          <p>To apply the self-management telenursing program and telenursing system developed by the researchers to Bangladesh to evaluate its feasibility and efficacy (improved diabetes control in participants)</p>
        </sec>
        <sec>
          <title>Specific Objectives</title>
          <list list-type="bullet">
            <list-item>
              <p>To control patients’ diabetic condition by measuring HbA<sub>1c</sub>.</p>
            </list-item>
            <list-item>
              <p>By having them acquire self-management behaviors and increase their self-efficacy, to minimize the risk of arising diabetic complications.</p>
            </list-item>
            <list-item>
              <p>To see the feasibility and barriers to implementing telenursing among patients with diabetes in Bangladesh.</p>
            </list-item>
          </list>
        </sec>
        <sec>
          <title>Research Questions</title>
          <p>Whether implementing a health education program will improve diabetic patient outcomes or not and will be operational and acceptable by the patients and health care professionals in Bangladesh.</p>
        </sec>
        <sec>
          <title>Hypothesis</title>
          <list list-type="order">
            <list-item>
              <p>The diabetes self-management program developed by the researchers cannot improve the participants’ management of their diabetes (avoid aggravation, develop complications, and hospitalization) (H<sub>0</sub>) or can improve the participants’ management of their diabetes (H<sub>1</sub>).</p>
            </list-item>
            <list-item>
              <p>Is the telenursing system developed by the researchers operational in Bangladesh? Can the system be used by health care personnel (nurses) and patients? What are the obstacles and challenges, if any, in using the system?</p>
            </list-item>
            <list-item>
              <p>Is the diabetes self-management program developed by researchers acceptable to health care providers and patients? How about engagement? Will the program be continued (will there be dropouts)? If so, what are the reasons?</p>
            </list-item>
          </list>
        </sec>
      </sec>
    </sec>
    <sec sec-type="methods">
      <title>Methods</title>
      <sec>
        <title>Design and Period</title>
        <p>A pilot study with a quasi-experimental pre- and postintervention design will be implemented. As we will try to explore the participants’ characteristics, we want to conduct a pilot study to see the feasibility of this project among these participants. We plan to conduct quasi-experimental pre- and postintervention design, as we found in this setting randomization; case-control is rather difficult. Therefore, we will enroll the participants and collect baseline data and then we will educate them, and after 6 months we will evaluate them and compare the baseline (pretest) and the endline (posttest) data of individual participants. We set 6 months, as a previous study showed that a patient’s behavioral modification requires at least 6 months of intervention [<xref ref-type="bibr" rid="ref18">18</xref>]. The study duration will be 1 year after getting approval from the Ethical Committee.</p>
      </sec>
      <sec>
        <title>Study Participants</title>
        <p>The participants are people with diabetes, who take services from Grameen primary health centers (PHCs). We use 2 PHCs from Sahorail and Jamshahat of Manikganj District in Bangladesh.</p>
        <sec>
          <title>Inclusion Criteria</title>
          <p>The inclusion criteria are as follows:</p>
          <list list-type="bullet">
            <list-item>
              <p>Having been diagnosed with type 2 diabetes</p>
            </list-item>
            <list-item>
              <p>Being of either sex</p>
            </list-item>
            <list-item>
              <p>Being 18-75 years</p>
            </list-item>
            <list-item>
              <p>Having a smartphone or mobile phone</p>
            </list-item>
            <list-item>
              <p>Willingness to participate and give us consent</p>
            </list-item>
          </list>
        </sec>
        <sec>
          <title>Exclusion Criteria</title>
          <p>The exclusion criteria are as follows:</p>
          <list list-type="bullet">
            <list-item>
              <p>Patients who have been diagnosed as type 1 and gestational diabetes</p>
            </list-item>
            <list-item>
              <p>Patients whose diabetes are secondary causes</p>
            </list-item>
            <list-item>
              <p>Patients who have complications of chronic kidney disease (CKD) stage 5</p>
            </list-item>
            <list-item>
              <p>Patients whose HbA<sub>1c</sub> has been less than 7% for the past 1 year with CKD stage 1 or 2, with no complications or complications with good control, have enough knowledge (had education before) and implemented good practice regarding diabetes management assessed by the research nurses (hereafter “the nurses”)</p>
            </list-item>
            <list-item>
              <p>Disabled persons who need other people’s support for daily living</p>
            </list-item>
          </list>
        </sec>
      </sec>
      <sec>
        <title>Sampling Technique</title>
        <p>We will use a purposive sampling technique to select the participants. Patients who meet the eligibility criteria will be introduced by physicians at the PHCs, and the nurses will contact them at the PHC and obtain their consent.</p>
      </sec>
      <sec>
        <title>Sample Size</title>
        <p>We calculated the sample size using G*Power software (version 3.1.9.7; Heinrich-Heine-University). As this is a pilot study, we set an effect size of 0.39 considering the differences between 2 dependent matched pair means of HbA<sub>1c</sub> from a previous study [<xref ref-type="bibr" rid="ref19">19</xref>], with a level of significance of 5%, and 80% power, the total sample size is calculated at 54. As patients have many options to discontinue the study (consent, withdraw, migration, change the health care facilities based on the disease severity, complications, hospitalization, etc), we consider a 30% dropout (16 participants) for this study. Therefore, the total sample size is estimated to be 70 (<xref ref-type="boxed-text" rid="box1">Textbox 1</xref>).</p>
        <boxed-text id="box1" position="float">
          <title>Output of software after generating sample size calculation.</title>
          <p>Effect size dz = 0.39</p>
          <p>α err prob = 0.05</p>
          <p>Input: Tail(s) = 2</p>
          <p>Power (1-β err prob) = 0.80</p>
          <p>Output: Noncentrality parameter δ = 2.8659030</p>
          <p>Critical <italic>t</italic>= 2.0057460</p>
          <p>Df = 53</p>
          <p>Total sample size = 54</p>
          <p>Actual power = 0.8033525</p>
        </boxed-text>
      </sec>
      <sec>
        <title>Method of Data Collection Procedures</title>
        <p>The principal investigator (PI) and co-investigators (telenurses) received training in telenursing such as communication and behavior modification techniques, and self-management skills on diabetes including blood sugar control and foot care. They will receive study-specific training from other coinvestigators and one diabetic consultant on data collection such as how to collect data and what type of tool has to be used during data collection. The patients who will attend the PHCs and telenurses will identify the patients with diabetes by checking the patient’s blood test report. They will check the participants’ eligibility criteria (inclusion and exclusion criteria) and obtain written informed consent. It will be ensured that there will be no risk in disclosing the information.</p>
        <p>They will educate patients using an investigator-developed “Education Booklet” at the PHCs. The booklet will be given to the patients after receiving consent and health education will be provided at the time as scheduled (<xref ref-type="supplementary-material" rid="app1">Multimedia Appendices 1</xref> and <xref ref-type="supplementary-material" rid="app2">2</xref>). The data will be collected within a 6-month study period using:</p>
        <list list-type="order">
          <list-item>
            <p>“Initial assessment sheet” developed by the investigators. It will be filled out once by the telenurses in the PHCs to assess the patient’s initial condition and to set the goals for their behavior change. This contains sociodemographic, clinical history, and lifestyle.</p>
          </list-item>
          <list-item>
            <p>“Self-monitoring book” developed by the investigators (<xref ref-type="supplementary-material" rid="app3">Multimedia Appendix 3</xref>). Patients will complete their daily life activities including their laboratory investigation reports at home. The telenurses will educate and guide them on how to fill it over telecommunication. This contains daily practice goals (eg, energy intake, salt, exercise, ideal weight), laboratory data record (eg HbA<sub>1c</sub>, fasting blood sugar [FBS] or random blood sugar [RBS], lipid profile, and renal function), foot care (monthly check), daily recording (RBS if needed, blood pressure, medication intake, daily goal achievement of diet and exercise) and behavior change goals (monthly).</p>
          </list-item>
          <list-item>
            <p>“Diabetes management self-efficacy scale” developed by Bijl et al [<xref ref-type="bibr" rid="ref20">20</xref>] and has 20 items with a 5-point Likert scale from 1-5. The scores range from 20 to 100, a higher point indicates better self-efficacy.</p>
          </list-item>
          <list-item>
            <p>The “Lifestyle behavior questionnaire” developed by the investigators has 6 items with a 6-point Likert scale from 0 to 5, a higher point indicates a better lifestyle. This is asked every month to check their behavior by the telenurse.</p>
          </list-item>
          <list-item>
            <p>“Patient Satisfaction” on tele-education and prepared materials developed by the investigators. It has 6-item with a 6-point Likert Scale, and higher indicates more satisfaction.</p>
          </list-item>
          <list-item>
            <p>A “Monthly outcome checklist” was developed by the investigators (<xref ref-type="supplementary-material" rid="app4">Multimedia Appendix 4</xref>). The telenurses interview patients monthly asking about education material use, goal attainment, and complication management. The engagement rate and follow-up rate also will be counted every month by the telenurses.</p>
          </list-item>
        </list>
        <p>All of the above except Diabetes management self-efficacy scale (number 3), was reviewed by the investigator team with the telenursing, diabetes, and chronic care nursing specialists for validity.</p>
        <p>Data on all complications of diabetes will be asked of the patients by the investigators and check the accuracy of the information from the records.</p>
      </sec>
      <sec>
        <title>Research Collaboration Framework</title>
        <p>We will use the telenursing model with the collaboration of the Hiroshima University telenursing center and the Nursing Research Center of Grameen Caledonian College of Nursing (GCCN) (<xref rid="figure1" ref-type="fig">Figure 1</xref>).</p>
        <fig id="figure1" position="float">
          <label>Figure 1</label>
          <caption>
            <p>Research collaboration framework.</p>
          </caption>
          <graphic xlink:href="resprot_v14i1e71849_fig1.png" alt-version="no" mimetype="image" position="float" xlink:type="simple"/>
        </fig>
      </sec>
      <sec>
        <title>Intervention</title>
        <sec>
          <title>Operational Definition of Self-Management and Structure of the Self-Management Program</title>
          <p>The focus of this program is the acquisition of self-management skills, operationally defined in <xref rid="figure2" ref-type="fig">Figure 2</xref>. First, the patients analyze their laboratory data and lifestyles including diet, and understand their condition so that they can work with their physiological data by acquiring knowledge of both the disease and self-care. By making self-supported decisions, the patients can manage their diet, exercise, and medication. They also acquire disease-specific management skills. Setting goals and then monitoring them ensures the continuation of the desired behavior and gives the patients control over their lifestyle [<xref ref-type="bibr" rid="ref19">19</xref>].</p>
          <fig id="figure2" position="float">
            <label>Figure 2</label>
            <caption>
              <p>Structure of the self-management program.</p>
            </caption>
            <graphic xlink:href="resprot_v14i1e71849_fig2.png" alt-version="no" mimetype="image" position="float" xlink:type="simple"/>
          </fig>
        </sec>
        <sec>
          <title>Process of Providing Education</title>
          <p><xref rid="figure3" ref-type="fig">Figure 3</xref> shows the 6-month program process. Because of the pilot study, we set a program for 6 months.</p>
          <p>Right after the nurses obtain consent from participants, the nurses conduct the initial assessment using an “Initial assessment sheet” and provide educational materials (“Education booklet” and “Daily monitoring notebook”). If needed, a weight machine, BP machine, medication box, salt measurement spoon, foot care set (monofilament, mirror, nail cutter, nail file, and socks), and eye check chart will be provided. If needed, a blood glucose meter is rented to the patients.</p>
          <p>Group education (1 group of less than 20 patients) will be provided at the PHC by the nurses on the scheduled date (1 group education is set for 2 hours).</p>
          <p>One week after the group session, telephone calls from the nurses (telenursing education) will be provided weekly on the first month, then biweekly from the second month to the six month. The nurses will contact patients periodically over the telephone, smartphone, or tablet and follow-up on their regular dietary behavior, physical activities, and medicine compliance. They will check clinical examination and laboratory test reports, self-monitoring data, and behavior changes.</p>
          <fig id="figure3" position="float">
            <label>Figure 3</label>
            <caption>
              <p>The 6-month program process.</p>
            </caption>
            <graphic xlink:href="resprot_v14i1e71849_fig3.png" alt-version="no" mimetype="image" position="float" xlink:type="simple"/>
          </fig>
          <p>In the third month, patients are requested to visit the PHC for regular follow-up by physician and laboratory test. In the sixth month group evaluation for 1 hour and endline data will be collected by the nurses at the PHC.</p>
          <p>Patients will start implementing diabetes management right after group education. Each patient will develop monthly goal settings (behavior change plan) related to their diabetes management, daily practice them, and record the results every day in the self-monitoring notebook. The nurses call each patient on the scheduled day, ask about his or her behavior changes and monitor data, then make “step-up goals” for the next month. In addition, based on his or her knowledge and practice level, the nurses provide education using the education booklet. Patients and nurses repeat these activities for 6 months.</p>
        </sec>
      </sec>
      <sec>
        <title>Outcomes and Data Collection Schedule</title>
        <p>Since this is a pilot study, we set various indicators (<xref ref-type="supplementary-material" rid="app5">Multimedia Appendix 5</xref>). The primary outcome is set as a change in HbA<sub>1c</sub>. As the secondary outcomes, we set various evaluation indicators. The data collection schedule is also set in <xref ref-type="supplementary-material" rid="app5">Multimedia Appendix 5</xref>.</p>
        <p>Sociodemographic data, clinical history, and lifestyle are taken at the initial assessment (Initial assessment sheet). Satisfaction is measured by the Likert scale (Satisfaction scale). Achievement of monthly goals is measured by percentage. Behavior change is measured by the researcher-developed scale (Lifestyle behavior questionnaire). Self-efficacy is measured by the Diabetes Management Self-Efficacy Scale.</p>
        <p>Qualitative data will be interviewed, described, or recorded when it occurs. Engagement and follow-up rate, education material used, complication management, and “patients who have achieved HbA<sub>1c</sub> in recommended level” will be counted. Cost-effectiveness will be calculated.</p>
      </sec>
      <sec>
        <title>Statistical Analysis</title>
        <p>Descriptive statistics will be expressed as frequencies and percentages for categorical variables and mean with SD or median with quantile, distribution, and range for the continuous variables. To compare the categorical variables between pre- and postdata, the chi-square test will be performed. To compare feasibility and efficacy (pre and post), continuous variables will be compared by paired <italic>t</italic> test or one-way ANOVA for the normally distributed and or McNemar test or Wilcoxon signed-rank sum test for the not normally distributed variables after checking the data normality. Qualitative data will be described and categorized if necessary. Statistical significance will be set as &#60;0.05. Data will be analyzed using IBM SPSS Statistics for Windows, Version 25.0 (IBM Corp).</p>
      </sec>
      <sec>
        <title>Ethical Considerations</title>
        <p>This study was approved by the institutional review board of the Bangladesh Medical Research Council (BMRC/NREC/2022-2025/336). The researcher will explain the consent procedures including the purpose, procedure, confidentiality, right to withdraw from the study, risk, and benefits, and will obtain written informed consent (ICFs) individually from all the participants. To maintain privacy and confidentiality, data will be collected anonymously. The data will be stored on two password-protected computer sets in the GCCN research room. After deleting all personal identifying information, anonymized data will be used for data analysis, so that research participants will not be identified. To participate in this study, we will not provide any money to the participants. We will provide all the treatments free of cost. As there is no risk or minimum risk to participate in this study, therefore, we will not provide any compassion to participate in this study. We ensure that identifiable features of research participants in any images of the manuscript or supplementary material will not be visible.</p>
        <sec>
          <title>Interpretation</title>
          <p>Data will be cleaned, organized, and verified by investigators as well as checking for any missing data or error data. Then analyze, interpret the findings, conclude, recommend dissemination, and further publication.</p>
        </sec>
        <sec>
          <title>Training of the Study Nurses</title>
          <p>The study nurses received overseas telenursing training on materials development and telenursing services. They have regular oriented sessions about the telenursing research activities with the investigators before the study initiation. They have been receiving protocol-specific hands-on training on how to collect data to perform procedures about self-care and behavioral changes.</p>
        </sec>
        <sec>
          <title>Procedure for Maintaining Confidentiality</title>
          <p>This research will be conducted in accordance with the “Declaration of Helsinki (2013)” by the World Medical Association. This research will be conducted in compliance with the ethical guidelines set forth by the institutional review board of the Bangladesh Medical Research Council (BMRC). The IRB ensures that the human participants are protected through the study. Before enrolling in this study, we will get written informed consent from the participants. Furthermore, we will keep confidentiality maintain through the research process. The researchers of our study will take all necessary steps to ensure the anonymity of the participants. The shared information will not be identified. We will keep all medical information, description of treatment, and results of the laboratory tests confidential, under lock and key, and only our key research staff will have access to this information. The regular monitoring and evaluation system will be conducted to ensure the implementation of preventative measures, or any other potential risk arising during the study. All the study-related information will be kept under lock and key in a secure data store. An appropriate password-based login mechanism would be used to prevent unauthorized access to the server. The collected information would only be visible to authorized research team leaders on a need basis.</p>
          <p>No identifiable information would be published anywhere.</p>
        </sec>
        <sec>
          <title>Reasons for Termination of the Study</title>
          <p>The study would be terminated based on the following reasons:</p>
          <list list-type="order">
            <list-item>
              <p>Unpredicted ethical concerns that could not be adequately addressed.</p>
            </list-item>
            <list-item>
              <p>Unexpected negative events or any harm to participants.</p>
            </list-item>
            <list-item>
              <p>Insufficient participant enrollment</p>
            </list-item>
            <list-item>
              <p>Financial barriers that could affect the feasibility of the study.</p>
            </list-item>
          </list>
          <p>
            <bold>Discontinuation of Research</bold>
          </p>
          <p>The PI will consider whether to continue the research if any of the following applies:</p>
          <list list-type="order">
            <list-item>
              <p>When the ethics review committee has given instructions to change the implementation plan, it is deemed difficult to accept such instructions.</p>
            </list-item>
            <list-item>
              <p>When facts or information that undermine the ethical validity or scientific rationality of the research are obtained.</p>
            </list-item>
            <list-item>
              <p>When facts or information that undermine the appropriateness of the implementation of the research or the credibility the research results are obtained.</p>
            </list-item>
          </list>
        </sec>
        <sec>
          <title>Quality Assurance, Control, and Data Monitoring</title>
          <p>The study quality will be assured and controlled by the PI and other investigators. Data will be collected by the trained research nurses. The participants’ names will be coded by a unique ID number, and the data will be recorded with the IDs to maintain confidentiality. The data will be cross-checked among the research team. Data will be entered by the nurses. If any discrepancy is found, it will be corrected before data entry. A weekly meeting will be held among the research team to discuss the study and resolve if there will be any study-related confusion.</p>
        </sec>
      </sec>
    </sec>
    <sec sec-type="results">
      <title>Results</title>
      <p>The project was funded in 2024. The enrollment of the participants started on October 26, 2024, and as of February 2025, all the participants (N=70) were enrolled. Data analysis will be started after the completion of follow-up data collection and the first results are expected to be submitted for publication in 2026 if all information is available.</p>
    </sec>
    <sec sec-type="discussion">
      <title>Discussion</title>
      <sec>
        <title>Principal Findings</title>
        <p>The results of the research will be disseminated in international scientific conferences and will be published in the <italic>International Science Citation Index (SCI) Journals</italic>. If the results show significance, we will share them with the policymakers, stakeholders, and the research community to implement such interventions in the government and private hospitals. Patients with diabetes will benefit, and it will reduce morbidity and mortality and will reduce patients’ and national economic burden. To control diabetes, health education and lifestyle changes such as food habits, exercise, and medication adherence are imperative. By doing this research, we can improve quality of life by controlling diabetes and preventing complications and death. In this way, we can also decrease the number of hospital visits and admissions and economic burden. This study will increase patients’ health literacy so that they can share their health knowledge with their peers and in the community. The study findings may assist us in the future implementation of telenursing interventions with a large sample size for determining factors that influence the quality of life among patients with diabetes.</p>
      </sec>
      <sec>
        <title>Future Perspectives</title>
        <p>By implementing this pilot study, we would like to see the feasibility and significance of this study. We can understand the potential barriers to use the telenursing system. Based on this study, we can revise the methodology and use multiple sites to make further research more effective. If we find our disease management program is effective, we can scale up this program throughout the country. Moreover, government and other nongovernment and private organizations can adopt this program and integrate into the existing health care system of Bangladesh. We can establish a public-private partnership incorporating all the stakeholders to develop a sustainable telenursing system [<xref ref-type="bibr" rid="ref21">21</xref>].</p>
      </sec>
      <sec>
        <title>Limitations</title>
        <p>This study has certain limitations. As we use a purposive sampling technique for selecting the study sites and participants, it causes selection bias. This is a pre- and poststudy design, not using any control group, and thus no causal inferences could be made. We will use appropriate statistics to understand associations in outcome measures to minimize biases [<xref ref-type="bibr" rid="ref22">22</xref>]. We use 2 rural PHCs from one district; therefore, our findings cannot be generalized for the population of the whole country. Some of the enrolled patients may not understand and follow the study procedures, so we can arrange group education via video conference to minimize this.</p>
      </sec>
      <sec>
        <title>Facilities Available</title>
        <p>GCCN has 76 different PHCs throughout Bangladesh. PHC receives patients with diabetes. They also have laboratory facilities to diagnose patients with diabetes. In this study, we have trained investigators and diabetic consultants who will conduct research activities and will provide consultancy. All the data will be entered into a password-protected computer and documents will be kept in the cabinet with a lock and key. Telecommunication will be conducted using smartphones.</p>
      </sec>
      <sec>
        <title>Conclusions</title>
        <p>By participating in this study, patients with diabetes will acquire disease-specific self-management skills and can manage a healthy lifestyle and prevent complication.</p>
      </sec>
    </sec>
  </body>
  <back>
    <app-group>
      <supplementary-material id="app1">
        <label>Multimedia Appendix 1</label>
        <p>Education booklet.</p>
        <media xlink:href="resprot_v14i1e71849_app1.docx" xlink:title="DOCX File , 285 KB"/>
      </supplementary-material>
      <supplementary-material id="app2">
        <label>Multimedia Appendix 2</label>
        <p>Education Booklet_Bengali.</p>
        <media xlink:href="resprot_v14i1e71849_app2.pdf" xlink:title="PDF File  (Adobe PDF File), 5100 KB"/>
      </supplementary-material>
      <supplementary-material id="app3">
        <label>Multimedia Appendix 3</label>
        <p>Self-monitoring Book.</p>
        <media xlink:href="resprot_v14i1e71849_app3.pdf" xlink:title="PDF File  (Adobe PDF File), 651 KB"/>
      </supplementary-material>
      <supplementary-material id="app4">
        <label>Multimedia Appendix 4</label>
        <p>Outcome checklist.</p>
        <media xlink:href="resprot_v14i1e71849_app4.docx" xlink:title="DOCX File , 20 KB"/>
      </supplementary-material>
      <supplementary-material id="app5">
        <label>Multimedia Appendix 5</label>
        <p>The outcome table and data collection schedule.</p>
        <media xlink:href="resprot_v14i1e71849_app5.docx" xlink:title="DOCX File , 19 KB"/>
      </supplementary-material>
    </app-group>
    <glossary>
      <title>Abbreviations</title>
      <def-list>
        <def-item>
          <term id="abb1">BMRC</term>
          <def>
            <p>Bangladesh Medical Research Council</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb2">CGM</term>
          <def>
            <p>continuous glucose monitoring</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb3">CKD</term>
          <def>
            <p>chronic kidney disease</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb4">FBS</term>
          <def>
            <p>fasting blood sugar</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb5">GCCN</term>
          <def>
            <p>Grameen Caledonian College of Nursing</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb6">HbA<sub>1c</sub></term>
          <def>
            <p>hemoglobin A<sub>1c</sub></p>
          </def>
        </def-item>
        <def-item>
          <term id="abb7">ICF</term>
          <def>
            <p>informed consent</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb8">LMIC</term>
          <def>
            <p>low- and middle-income country</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb9">NCD</term>
          <def>
            <p>noncommunicable disease</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb10">PHC</term>
          <def>
            <p>Primary Health Center</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb11">PI</term>
          <def>
            <p>principal investigator</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb12">RBS</term>
          <def>
            <p>random blood sugar</p>
          </def>
        </def-item>
      </def-list>
    </glossary>
    <ack>
      <p>The authors would like to thank all the respected personnel of Grameen Primary Health Centers, the diabetes specialist, and patients for their kind patience and willful participation in this study. The study is funded by the restricted grants of Hiroshima University, Japan.</p>
    </ack>
    <notes>
      <sec>
        <title>Data Availability</title>
        <p>The datasets generated and analyzed during this study are available from the corresponding author on reasonable request.</p>
      </sec>
    </notes>
    <fn-group>
      <fn fn-type="con">
        <p>MM, KATMEH, and NSN performed supervision. MM, LM, ARM, and KATMEH performed data curation. LM, ARM, and NSN performed the investigation and methodology. MM also contributed to methodology and handled funding acquisition. MM and NSN handled project administration. MM and NSN managed resources. KATMEH managed software. MM and KATMEH conducted validation. MM and KATMEH performed visualization. KATMEH wrote the original draft. All authors contributed to the conceptualization, writing–review and editing, and approval of the submitted manuscript.</p>
      </fn>
      <fn fn-type="conflict">
        <p>None declared.</p>
      </fn>
    </fn-group>
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