Type 2 diabetes (T2D) occurs in up to 20% of people aged ≥70 years. T2D is a progressive disease with an increased risk of cardiovascular disease, cancer, and dementia. Physical inactivity and being overweight owing to an unhealthy lifestyle, such as that involving the use of tobacco and alcohol consumption, are key factors in the progression of T2D [1,2]. T2D requires both active self-management of people living with the disease and advanced medical treatment over time [1,2,3]. About 350,000 people living in Sweden are diagnosed with T2D [3], and the risk increases with age, regardless of gender [2,3]. Education levels relate to diabetes development, the higher the education, the lower the incidence. The incidence also varies by country (of birth) with higher prevalence among people born in the Nordic countries than in Europe outside Scandinavia [3].

Caring for people with T2D is a challenge for society, especially in rural areas that suffer from a shortage of general practitioners in primary health care [4]. In Sweden, primary health care nurses with responsibility for diabetes clinics (diabetes specialist nurses, DSNs) have a heavy workload and are often responsible for a large number of T2D patients regarding self-management support (SMS) and follow-ups. SMS includes motivating T2D patients to quit smoking, increase physical activity, change diet, initiate weight loss, and adhere to medication and blood sugar testing [5], all examples of frequent work tasks that fall on DSNs. The medical treatment is multifactorial and includes monitoring of blood sugar targets, blood pressure (BP), blood lipids, and other medical measures [6]. Furthermore, preventive measures such as retinal scans [7] and annual foot examinations are of great importance for delaying complications [8].

T2D is a complex disease with complex treatment, in which self-management is the basic treatment [9-11]. In recent years, SMS in groups and culturally appropriate education have been recommended, led by staff with both subject expertise and pedagogical training [3]. Findings in studies [10,12] show that SMS or patient education in groups and directed to individuals are equally effective among people with T2D and result in similar improvements in learning, behavioral, and clinical outcomes. In diabetes care, there have to be various individual options and scope for those who do not want to participate in or fit into groups. Additionally, person-centered care (PCC) that enables custom solutions and person-centered approaches that strengthen self-efficacy and patient empowerment are beneficial [10,13-14]. Electronic health (eHealth) interventions for chronically ill patients, instead of or in addition to usual care, can lead to positive effects on primary health outcomes [15]. eHealth interventions are also requested today and are motivated not only by the problems of geographical distance [16] and lack of health care staff [17] but also by the opportunities offered by the approach, namely, strengthened power and ownership as well as increased person-centeredness. Therefore, we believe that it is important to develop SMS using an eHealth intervention.

Recent research suggests that patients view the use of smartphone apps for self-monitoring and channels aimed at social support and interaction with the caregiver via computers and smartphones [18] as a good and important complement to traditional care. Some patients, however, express doubt about the technological issues that may arise [19]. A challenge may also be health care staff’s hesitation to use eHealth and mobile health in patient care. A recent interview study [20] among nurses in primary health care indicates that they viewed the trend toward eHealth approaches in patient care as unavoidable. However, the transition from traditional face-to-face visits to eHealth support could lead to a lack of control in their daily work, and they expressed a need to protect both themselves and the patients in the digital chaos created [20,21]. They preferred to meet patients face-to-face and saw a risk in the ongoing role change that may lead to losing their expert role in providing practical advice to patients. The solution could be to involve patients with T2D and DSNs in working together to develop an intervention with both obstacles and opportunities within their respective perspectives in mind. Several researchers recommend this kind of co-design and participatory design [22-24] since the implementation of new ideas is facilitated; these become accepted by users and are thereby longer-term solutions.

The purpose of the interactive self-management support (iSMS) project is to include digital tools by offering the use of a smartphone or tablet app to support people living with T2D in self-management and to facilitate interaction with DSNs. This study protocol outlines a randomized controlled trial (RCT) to evaluate the effectiveness of person-centered iSMS in primary health care. This study puts a particular focus on how digital technology is used as a tool for self-management in daily life, wherein patients with T2D manage their illness in closer collaboration with DSNs through self-monitoring and self-care activities. The objectives of this project are to develop and evaluate a person-centered iSMS intervention in primary health care for people with T2D in addition to their usual diabetes care. The hypotheses are that an iSMS program will decrease glycated hemoglobin (HbA_1c) and improve metabolic measurements, such as BP (mm HG), body mass index, waist circumference (cm), and total and high-density lipoprotein cholesterol (mmol/L). Furthermore, we hypothesize that an iSMS program will improve lifestyle habits such as physical activity, diet, and smoking; decrease the need for SMS and changes in medical treatment; increase diabetes empowerment; increase diabetes-dependent quality of life (QoL); improve illness perception; and improve eHealth literacy in the intervention group compared with an internal (intervention and control) and external control group at 4 and 12 months’ follow-up.

This randomized intervention study is grounded on the theoretical perspectives of PCC, which is a care model that supports the person’s views about their life situation and condition as being indisputable and is always at the center of care. According to PCC, patients are persons who are more than their illness. PCC is based on the patient’s experience of the situation and the individual’s circumstances, resources, and obstacles. PCC has been described as the gold standard of care that will help individuals to develop the knowledge, skills, and confidence they need to more effectively manage and make informed decisions about their health or illness and health care and thus become partners in care. It also means that the patient should always be treated with respect. PCC is a partnership between patients or relatives and professional caregivers. It requires that health care professionals and patients together lay the ground for a relationship or partnership. The starting point for PCC is the patient’s story, which should be written in a structured way into a health plan that includes the goals and strategies for implementation and short- and long-term follow-up [25,26]. By shifting from an illness focus to a strengths-based, person-centered one, this intervention may change the usual care for people with T2D in primary health care. The process is intended to develop and implement an actionable plan to assist people with T2D in achieving their personal goals in the “illness process”. This RCT is intended to address the specific barriers that interfere with the person’s personal goal achievement; the aims are to transform and offer the participants a process for sustainable behavior change to fulfill their personal goals.

This protocol describes a 3-armed, nonblinded RCT to evaluate the effectiveness of person-centered iSMS in primary health care on metabolic balance, as measured by HbA_1c. Within this project, interactive SMS (iSMS) is defined as person-centered and interactive self-management support. The person-centered part lies in an assessment of individual needs for SMS through a quantitative measurement and by listening to patients’ stories. The interactive part lies in the patients’ use of a smartphone or tablet app for self-monitoring and also interaction with the nurse and other participants through a patient forum when needed. Furthermore, other digital sources, such as a website with information about T2D, self-care, and so forth, will be included in the intervention. This protocol was prepared according to the Consolidated Standards of Reporting Trials [27], the Consolidated Standards of Reporting Trials extension for Electronic and mobile Health Applications and onLine TeleHealth interventions [28], and the Standard Protocol Items: Recommendations for Intervention Trials guidelines [29,30].

DSNs will be trained in using the SMASc questionnaire to score the SMS needs. They will also be trained in using and instructing participants how to use the app. Furthermore, they will be taught how to use the Web page, with diabetes facts and illness integration support, included in the project. All recommendations to patients will be based on patients’ stories and expressed needs as well as patients’ scores on the SMASc questionnaire to make the individual plans person-centered.

Both the intervention and control groups will continue with their usual diabetes care, including all medical visits, tests, and diabetes support programs. The starting point for the 4-months’ intervention is the baseline scoring on the SMASc questionnaire, resulting in a tailored person-centered plan for self-management through monitoring and interaction with DSN. The intervention group will receive the app, including instructions on how to use it, and the Web page with diabetes facts, as described above. DSNs will also assist in installing the app on the participants’ smartphone or tablet. The software can be personally tailored according to the participant’s needs to provide a personal overview of how food, exercise, medicine, blood sugar, and BP interact. The participants can evaluate food intake, blood glucose levels, insulin, medicine intake, exercise (physical activity), and weight over time and receive reminders if they would like them. Participants may, if they wish, choose whether their DSN should have access to their data or not. The system will maintain logs of all outgoing and incoming messages, and incoming blood glucose values will be graphed by the system, which individuals can view.

A power calculation showed that with a sample of 46 participants per group, a power of 80% with an alpha<.05 will demonstrate significant HbA_1c difference of 6 mmol/mol between the groups and a within-group SD assumed to be 9 [10]. This means that there is an 80% likelihood that the study will yield a statistically significant effect and allow us to conclude that the mean HbA_1c differs between the intervention group versus the control group. To compensate for dropouts, the study needs to enroll 46 participants per group for a total of at least 120 participants.

Eligible participants will be randomized to either the intervention or the control groups in a 1:1 ratio. Owing to the nature of the intervention, participants will be aware of their treatment allocation. Therefore, the blinding of participants will not be possible. However, DSNs in charge at HCCs will not be involved in the randomization, preparation of the envelopes with study information, or statistical analyses.

Sampling will be conducted both at the organizational HCC level and at the patient level. First, primary health care managers at HCCs in a county in northern Sweden have previously received verbal and written information on the purpose of the study and the implementation process as well as inclusion criteria, and all have accepted participation. After receiving consent from primary health care managers, DSNs at 6 HCCs accepted participation, got verbal and written information about the study, and were invited to participate in the co-design and participatory workshop and the RCT study and were further asked to collaborate in patient recruitment using a clustered RCT design.

At baseline and 4 and 12 months’ evaluation, assessments will be conducted. Baseline assessments will involve the collection of demographic data regarding age, gender, marital or family relationships, housing, education, and employment; self-reported outcome measures via questionnaires; and collection of laboratory tests and physical measurements via participants’ medical records. Finally, information regarding diabetes duration, tobacco use, prescribed medication, diet, and exercise habits will be collected. For the follow-up assessments, completion of self-reported outcome measures via questionnaires and collection of laboratory tests and physical measurements via participants’ medical records will be performed.

All analyses to evaluate change over time with regard to intervention outcomes will be made with the intention-to-treat principle, which means that all participants are analyzed according to the group they were randomized into [50]. Appropriate imputation methods will be applied to the missing data.

Baseline and sociodemographic characteristics will be summarized using descriptive statistics. Continuous variables will be summarized as numbers of observed values and mean (SD) or median and quartiles when appropriate. Categorical variables will be described using central tendencies and variability. Differences between groups will be analyzed using inferential statistics.

This study will conform to the principles of the declaration of Helsinki [51]. Ethical approval for this trial was granted by the Regional Ethical Review Board at Umeå University (Dnr 2014-179-31M). The major ethical considerations for this study concern the data collection, which might be experienced as tiresome for the participants. However, this risk for the participants is judged as relatively small in comparison with the benefits of receiving person-centered SMS.

This study protocol describes a planned project aiming to develop and implement an intervention consisting of person-centered, iSMS in primary health care for people with T2D and to evaluate its effectiveness. An intervention like this, in which patients and health care providers are involved in the developmental phase, can lead to more effective SMS and sustainable longer-term effects on health among patients.

The design for this intervention is based on experiences in the research group from previously conducted focus group interviews with primary health care nurses, individual interviews with patients with T2D, a multistakeholder workshop, and results from other studies [19,20,52,53]. Merging current research is beneficial to develop clinically useful interventions based on theory, which could be tailored more specifically for the participants through a cocreative design [54].

Any modifications to the study protocol will be discussed and agreed upon by consensus between the research group before implementing them, and all changes will be documented in a memorandum.

This study, with its focus on iSMS, will provide insights regarding suitable ways to promote and develop a person-centered intervention regarding the usage of mobile tools. If successful, the intervention has the potential to become a model for the provision of SMS to people with T2D.