JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

Multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: design of a randomized controlled trial

Background: Background: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing quality of life (QoL) and increasing morbidity and mortality. For either single disease, a multidisciplinary disease-management approach supported by telecommunications technologies offers the best outcome in terms of prolonged survival and reduced hospital-readmissions. But no data exist in patients with combined COPD/CHF. Objective: Objective. We planned a randomized controlled trial to investigate the feasibility and efficacy of an integrated multidisciplinary telehealth home-based program versus conventional care in patients with coexisting CHF/COPD. The purpose of the paper is to the rationale and design of the trial. Methods: Methods: Patients, after inpatient rehabilitation, were randomly assigned to Intervention or Control, followed for 4 months at home, then assessed at 4 and 6 months. The intervention group followed a telesurveillance (phone-contacts by nurse and remote monitoring of cardiorespiratory parameters) and telerehabilitation home-based program (≥3 sessions/week of mini-ergometer, callisthenic exercises and twice weekly pedometer-driven walking, plus phone-contacts by physiotherapist). Telephone follow-up served to verify compliance to therapy, maintain exercise motivation, educate for early recognition of signs/symptoms, and verify the skills acquired. At baseline and 4 and 6 months, the 6-min walk test, dyspnea and fatigue at rest (Borg scale), oxygenation (PaO2/FiO2), physical activity profile (PASE questionnaire), and QoL (Minnesota and CAT questionnaires) were assessed. During the study, serious clinical events (hospitalizations or deaths) were recorded. Results: The data, currently being processed, will show whether telehealth management in combined COPD/CHF – complex, frail patients at high risk of exacerbations - is effective. Conclusions: Currently, no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF. Our study will show whether this approach is effective in the management of such complex, frail patients with very high risk of exacerbations. Clinical Trial: Trial registration: Clinical Trials NCT02269618

2015-02-19

We are pleased to announce our forthcoming new journals, all of which have currently no submission or publication fees, and all of which focus on emerging technologies and patient-centered innovations in specific areas, going beyond Internet/webbased interventions: * JMIR Cancer (http://cancer.jmir.org) * JMIR Medical Education (http://mededu.jmir.org) * JMIR Public Health and Surveillance (http://publichealth.jmir.org) We welcome submissions for the inaugural issues of these journals. The following journals have already published articles and are still free of charge to publish in (no submission or publication fees): * JMIR Human Factors (http://humanfactors.jmir.org) * JMIR Rehabilitation and Assistive Technologies (http://rehab.jmir.org) * JMIR Mental Health (http://mental.jmir.org) To submit to these journals, simply append /author to the URLs above (e.g. http://cancer.jmir.org/author), or submit to the main JMIR journal and use the dropdown-box in step 1 to change the journal name. All journals offer careful copyediting and typesetting of manuscripts, and submission to PubMed and PubMed Central (being new journals it may however take a few month until they appear in PubMed). We are also happy to announce that JMIR Medical Informatics and JMIR Serious Games are now indexed in PubMed.

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

  • JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor: 4.7)
  • JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
  • JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
  • Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 
  • JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
  • JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
  • JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
  • JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
  • Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
  • Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
 
 

Recent Articles:

  • Image showing the heart of a child born with an atrial septal defect (ASD). The heart has been emptied of blood, put on cardiopulmonary bypass (CPB), and arrested using the cardioplegia solution, which is injected into the aortic root after the aorta is cross-clamped. CPB is achieved by inserting a superior vena cava (SVC) and an inferior vena cava (IVC) cannula for the venous drainage and an aortic cannula for the arterial perfusion of the body. The right atrium is open and the ASD is clearly visible.

    Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial

    Abstract:

    Background: During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has been completed. The main rationale for “whole body cooling” is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body’s metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery (“normothermia”). However, the two techniques have not been extensively compared in children. Objective: The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. Methods: This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of genomic expression changes in cardiac tissue biopsies, and neuropsychological development. Results: A total of 141 patients have been successfully randomized over 2 years and 10 months and are now being followed-up for 1 year. Results will be published in 2015. Conclusions: We believe this to be the first large pragmatic study comparing clinical outcomes during normothermic versus hypothermic bypass in complex open heart surgery in children. It is expected that this work will provide important information to improve strategies of cardiopulmonary bypass perfusion and therefore decrease the inevitable organ damage that occurs during nonphysiological body perfusion. Trial Registration: ISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG).

  • The TOC image is a photo of an old child drawing done for one of the authors 30+ years ago in a school project.

    “Everybody Brush!”: Protocol for a Parallel-Group Randomized Controlled Trial of a Family-Focused Primary Prevention Program With Distribution of Oral...

    Abstract:

    Background: Twice daily toothbrushing with fluoridated toothpaste is the most widely advocated preventive strategy for dental caries (tooth decay) and is recommended by professional dental associations. Not all parents, children, or adolescents follow this recommendation. This protocol describes the methods for the implementation and evaluation of a quality improvement health promotion program. Objective: The objective of the study is to show a theory-informed, evidence-based program to improve twice daily toothbrushing and oral health-related quality of life that may reduce dental caries, dental treatment need, and costs. Methods: The design is a parallel-group, pragmatic randomized controlled trial. Families of Medicaid-insured children and adolescents within a large dental care organization in central Oregon will participate in the trial (n=21,743). Families will be assigned to one of three groups: a test intervention, an active control, or a passive control condition. The intervention aims to address barriers and support for twice-daily toothbrushing. Families in the test condition will receive toothpaste and toothbrushes by mail for all family members every three months. In addition, they will receive education and social support to encourage toothbrushing via postcards, recorded telephone messages, and an optional participant-initiated telephone helpline. Families in the active control condition will receive the kit of supplies by mail, but no additional instructional information or telephone support. Families assigned to the passive control will be on a waiting list. The primary outcomes are restorative dental care received and, only for children younger than 36 months old at baseline, the frequency of twice-daily toothbrushing. Data will be collected through dental claims records and, for children younger than 36 months old at baseline, parent interviews and clinical exams. Results: Enrollment of participants and baseline interviews have been completed. Final results are expected in early summer, 2017. Conclusions: If proven effective, this simple intervention can be sustained by the dental care organization and replicated by other organizations and government. Trial Registration: Trial Registration: ClinicalTrials.gov NCT02327507; http://clinicaltrials.gov/ct2/show/NCT02327507 (Archived by WebCite at http://www.webcitation.org/6YCIxJSor).

  • Screenshot of the online programs
Source: www.leefmeteczeem.nl ; www.leefmetvoedselallergie.nl.

    Usage and Users of Online Self-Management Programs for Adult Patients With Atopic Dermatitis and Food Allergy: An Explorative Study

    Abstract:

    Background: Two online self-management programs for patients with atopic dermatitis (AD) or food allergy (FA) were developed with the aim of helping patients cope with their condition, follow the prescribed treatment regimen, and deal with the consequences of their illness in daily life. Both programs consist of several modules containing information, personal stories by fellow patients, videos, and exercises with feedback. Health care professionals can refer their patients to the programs. However, the use of the program in daily practice is unknown. Objective: The aim of this study was to explore the use and characteristics of users of the online self-management programs “Living with eczema,” and “Living with food allergy,” and to investigate factors related to the use of the trainings. Methods: A cross-sectional design was carried out in which the outcome parameters were the number of log-ins by patients, the number of hits on the system’s core features, disease severity, quality of life, and domains of self-management. Descriptive statistics were used to summarize sample characteristics and to describe number of log-ins and hits per module and per functionality. Correlation and regression analyses were used to explore the relation between the number of log-ins and patient characteristics. Results: Since the start, 299 adult patients have been referred to the online AD program; 173 logged in for at least one occasion. Data from 75 AD patients were available for analyses. Mean number of log-ins was 3.1 (range 1-11). Linear regression with the number of log-ins as dependent variable showed that age and quality of life contributed most to the model, with betas of .35 ( P=.002) and .26 (P=.05), respectively, and an R2 of .23. Two hundred fourteen adult FA patients were referred to the online FA training, 124 logged in for at least one occasion and data from 45 patients were available for analysis. Mean number of log-ins was 3.0 (range 1-11). Linear regression with the number of log-ins as dependent variable revealed that adding the self-management domain “social integration and support” to the model led to an R2 of .13. The modules with information about the disease, diagnosis, and treatment were most visited. Most hits were on the information parts of the modules (55-58%), followed by exercises (30-32%). Conclusions: The online self-management programs “Living with eczema” and “Living with food allergy” were used by patients in addition to the usual face-to-face care. Almost 60% of all referred patients logged in, with an average of three log-ins. All modules seemed to be relevant, but there is room for improvement in the use of the training. Age, quality of life, and lower social integration and support were related to the use of the training, but only part of the variance in use could be explained by these variables.

  • (c) Cosmo et al (https://imageshack.com/i/exbnSW9Lj).

    Contribution of Transcranial Direct Current Stimulation on Inhibitory Control to Assess the Neurobiological Aspects of Attention Deficit Hyperactivity...

    Abstract:

    Background: The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. Objective: The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. Methods: A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. Results: The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. Conclusions: The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Trial Registration: Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD).

  • Copyright: Ammentorp Photography/Shutterstock.com and Karima/Shutterstock.com.

    Supportive Text Messages to Reduce Mood Symptoms and Problem Drinking in Patients With Primary Depression or Alcohol Use Disorder: Protocol for an...

    Abstract:

    Background: Depression and Alcohol Use Disorders (AUDs) are two leading causes of disability worldwide and are associated with significant treatment challenges requiring new, innovative, cost-effective and technologically-based therapies including the use of supportive text messages. Objective: To determine the feasibility and effectiveness of supportive text messages in long-term follow-up to reduce mood symptoms and problem drinking in patients with Depression or AUD respectively and to explore the usefulness of self-reports of health services utilization as an outcomes measure. Methods: This will be a longitudinal, prospective, parallel-design, two-arm, placebo-controlled single-rater-blinded randomized clinical trial with a recruitment period of 6 months and an observation period of 12 months for each participant, with two strata based on primary diagnosis of Major Depressive Disorder or AUD. The sample size will be 120, with about 60 patients randomized from each primary diagnostic grouping. Patients in all intervention groups will receive twice-daily supportive SMS text messages for 3 months and then daily supportive text messages for the next three months. Patients will also receive a phone call every two weeks from the research assistant assigning treatment allocation to confirm that they are still receiving the text messages and to thank them for taking part in the study. Patients in the control group will receive no text messages but will also receive a phone call from the same research assistant every two weeks to thank them for taking part in the study. Results: The study starts in April 2015 and ends in September 2016. It is envisaged that both qualitative and quantitative primary and secondary outcomes, including patient perceptions of the intervention, will shed light on the feasibility of using automated supportive text message interventions in long term for patients with Depression and AUD. This will inform a full-scale clinical trial. Conclusions: The paradigm for behavior change using text messages as a patient-direct intervention is consistent with a cognitive behavior therapy approach and addictions counselling principles. Given the automaticity of the messages, we anticipate that if the intervention proves successful, it will represent a low cost strategy that will be readily available and can bring relief to patients in hard-to-reach areas with limited access to psychological therapies. Trial Registration: ClinicalTrials.gov: NCT02327858; https://clinicaltrials.gov/ct2/show/NCT02327858 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02327858).

  • Dads in Gear website.

    Men’s Responses to Online Smoking Cessation Resources for New Fathers: The Influence of Masculinities

    Abstract:

    Background: Smoking cessation is the single most important step to preventing cancer. Drawing on previous research, Web-based resources were developed to complement a program to support expectant and new fathers to quit smoking. Objective: The objectives of this research were to: (1) describe the responses of expectant and new fathers who smoke or had recently quit smoking to the website resources, and (2) explore how masculinities shape men’s responses to and experiences with online smoking cessation resources. Methods: Using semi-structured, individual face-to-face interviews, the Dads in Gear Web-based resources were reviewed and evaluated by 20 new fathers who smoked or had recently quit smoking. The data were transcribed and analyzed using NVivo 8 qualitative data analysis software. Results: We describe the fathers’ reactions to various components of the website, making connections between masculinities and fathering within 5 themes: (1) Fathering counts: gender-specific parenting resources; (2) Measuring up: bolstering masculine identities as fathers; (3) Money matters: triggering masculine virtues related to family finances; (4) Masculine ideals: father role models as cessation aids; and (5) Manly moves: physical activity for the male body. Conclusions: A focus on fathering was an effective draw for men to the smoking cessation resources. The findings provide direction for considering how best to do virtual cessation programs as well as other types of online cancer prevention programs for men.

  • Image of the study for the homepage. One of the authors (Lasse Pere) has took the photo with the approval of the person in the photo so Mr. Pere has the copyright.

    Feasibility of Using a Multilingual Web Survey in Studying the Health of Ethnic Minority Youth

    Abstract:

    Background: Monolingual Web survey is a common tool for studying adolescent health. However, national languages may cause difficulties for some immigrant-origin youths, which lower their participation rate. In national surveys, the number of ethnic minority groups is often too small to assess their well-being. Objective: We studied the feasibility of a multilingual Web survey targeted at immigrant-origin youths by selection of response language, and compared participation in different language groups with a monolingual survey. Methods: The Adolescent Health and Lifestyle Survey (AHLS), Finland, with national languages (Finnish/Swedish) was modified into a multilingual Web survey targeted at a representative sample of 14- and 16-year olds (N=639) whose registry-based mother tongue was other than the national languages. The survey was conducted in 2010 (16-year olds) and 2011 (14-year olds). The response rate of the multilingual survey in 2011 is compared with the AHLS of 2011. We also describe the translation process and the e-form modification. Results: Of the respondents, 57.6% answered in Finnish, whereas the remaining 42.4% used their mother tongue (P=.002). A majority of youth speaking Somali, Middle Eastern, Albanian, and Southeast Asian languages chose Finnish. The overall response rate was 48.7% with some nonsignificant variation between the language groups. The response rate in the multilingual Web survey was higher (51.6%, 163/316) than the survey with national languages (46.5%, 40/86) in the same age group; however, the difference was not significant (P=.47). The adolescents who had lived in Finland for 5 years or less (58.0%, 102/176) had a higher response rate than those having lived in Finland for more than 5 years (45.1%, 209/463; P=.005). Respondents and nonrespondents did not differ according to place of birth (Finland/other) or residential area (capital city area/other). The difference in the response rates of girls and boys was nearly significant (P=.06). Girls of the Somali and Middle Eastern language groups were underrepresented among the respondents. Conclusions: A multilingual Web survey is a feasible method for gathering data from ethnic youth, although it does not necessarily yield a higher response rate than a monolingual survey. The respondents answered more often in the official language of the host country than their mother tongue. The varying response rates by time of residence, ethnicity, and gender pose challenges for developing tempting surveys for youth.

  • This is a royalty free image by stockimages (http://www.freedigitalphotos.net/images/stylish-guy-using-mobile-phone-photo-p228156).

    Bilingual Text Messaging Translation: Translating Text Messages From English Into Spanish for the Text4Walking Program

    Abstract:

    Background: Hispanic adults in the United States are at particular risk for diabetes and inadequate blood pressure control. Physical activity improves these health problems; however Hispanic adults also have a low rate of recommended aerobic physical activity. To address improving physical inactivity, one area of rapidly growing technology that can be utilized is text messaging (short message service, SMS). A physical activity research team, Text4Walking, had previously developed an initial database of motivational physical activity text messages in English that could be used for physical activity text messaging interventions. However, the team needed to translate these existing English physical activity text messages into Spanish in order to have culturally meaningful and useful text messages for those adults within the Hispanic population who would prefer to receive text messages in Spanish. Objective: The aim of this study was to translate a database of English motivational physical activity messages into Spanish and review these text messages with a group of Spanish speaking adults to inform the use of these text messages in an intervention study. Methods: The consent form and study documents, including the existing English physical activity text messages, were translated from English into Spanish, and received translation certification as well as Institutional Review Board approval. The translated text messages were placed into PowerPoint, accompanied by a set of culturally appropriate photos depicting barriers to walking, as well as walking scenarios. At the focus group, eligibility criteria for this study included being an adult between 30 to 65 years old who spoke Spanish as their primary language. After a general group introduction, participants were placed into smaller groups of two or three. Each small group was asked to review a segment of the translated text messages for accuracy and meaningfulness. After the break out, the group was brought back together to review the text messages. Results: A translation confirmation group met at a church site in an urban community with a large population of Hispanics. Spanish speaking adults (N=8), with a mean age of 40 (SD 6.3), participated in the study. Participants were engaged in the group and viewed the text messages as culturally appropriate. They also thought that text messages could motivate them to walk more. Twenty-two new text messages were added to the original database of 246 translated text messages. While the text messages were generally understood, specific word preferences were seen related to personal preference, dialect, and level of formality which resulted in minor revisions to four text messages. Conclusions: The English text messages were successfully translated into Spanish by a bilingual research staff and reviewed by Hispanic participants in order to inform the use of these text messages for future intervention studies. These Spanish text messages were recently used in a Text4Walking intervention study.

  • Features of the myCompass intervention.

    A Mobile Phone and Web-Based Intervention for Improving Mental Well-Being in Young People With Type 1 Diabetes: Design of a Randomized Controlled Trial

    Abstract:

    Background: Young people with type 1 diabetes experience elevated levels of emotional distress that impact negatively on their diabetes self-care, quality of life, and disease-related morbidity and mortality. While the need is great and clinically significant, a range of structural (eg, service availability), psychological (eg, perceived stigma), and practical (eg, time and lifestyle) barriers mean that a majority of young people do not access the support they need to manage the emotional and behavioral challenges of type 1 diabetes. Objective: The aim of this study is to examine the effectiveness of a fully-automated cognitive behavior therapy-based mobile phone and Web-based psychotherapeutic intervention (myCompass) for reducing mental health symptoms and diabetes-related distress, and improving positive well-being in this vulnerable patient group. Methods: A two-arm randomized controlled trial will be conducted. Young people with type 1 diabetes and at least mild psychological distress will be recruited via outpatient diabetes centers at three tertiary hospitals in Sydney, Australia, and referred for screening to a study-specific website. Data will be collected entirely online. Participants randomized to the intervention group will use the myCompass intervention for 7 weeks, while at the same time a control group will use an active placebo program matched to the intervention on duration, mode of delivery, and interactivity. Results: The primary outcome will be mental well-being (ie, depression, anxiety, diabetes-related distress, and positive well-being), for which data will be collected at baseline, post-intervention, and after 3 months follow-up. Secondary outcomes will be functional (work and social functioning and diabetes self-care), biochemical measures (HbA1c), and mental health self-efficacy. We aim to recruit 280 people into the study that will be conducted entirely online. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Conclusions: We hypothesize that scores on the outcome measures will improve significantly for young people who use the mobile phone and Web-based intervention compared to the control group. myCompass is a public health intervention that is broadly available and free to use. If effective, the program has the capacity to provide convenient and accessible evidenced-based care to the large group of young people with type 1 diabetes who do not currently access the psychosocial support they need. Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12614000974606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366607 (Archived by WebCite at http://www.webcitation.org/6YGdeT0Dk).

  • A tablet connected to the Mindwave mobile to reduce post-operative pain in lung cancer patients.

    A Neurofeedback-Based Intervention to Reduce Post-Operative Pain in Lung Cancer Patients: Study Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Thoracic surgery appears to be the treatment of choice for many lung cancers. Nevertheless, depending on the type of surgery, the chest area may be painful for several weeks to months after surgery. This painful state has multiple physical and psychological implications, including respiratory failure, inability to clear secretions by coughing, and even anxiety and depression that have negative effects on recovery. Objective: The aim of this study is to evaluate the effect of a neurofeedback-based intervention on controlling acute post-surgery pain and improving long-term recovery in patients who undergo thoracotomy for lung resection for non-small cell lung cancer (NSCLC) at an academic oncologic hospital. Methods: This study will be based on a 2-parallel group randomized controlled trial design, intervention versus usual care, with multiple in-hospital assessments and 2 clinical, radiological, and quality of life follow-ups. Participants will be randomized to either the intervention group receiving a neurofeedback-based relaxation training and usual care, or to a control group receiving only usual care. Pain intensity is the primary outcome and will be assessed using the Numeric Pain Rating Scale (NRS) in the days following the operation. Secondary outcomes will include the effect of the intervention on hospital utilization for pain crisis, daily opioid consumption, anxiety, patient engagement, blood test and chest x-ray results, and long-term clinical, radiological, and quality of life evaluations. Outcome measures will be repeatedly taken during hospitalization, while follow-up assessments will coincide with the follow-up visits. Pain intensity will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations. Results: We expect to have results for this study before the end of 2016. Conclusions: The proposed innovative, neurofeedback- and relaxation-based approach to support post-surgery pain management could lead to significant improvements in patient short and long-term outcomes.

  • PARO, a social robotic seal.

    Use of a Therapeutic, Socially Assistive Pet Robot (PARO) in Improving Mood and Stimulating Social Interaction and Communication for People With Dementia:...

    Abstract:

    Background: Socially assistive robotics is a growing area for geriatric research. Objective: This single-blind, randomized controlled trial (RCT) aims to investigate the use of PARO, a therapeutic, socially assistive pet robot, in improving mood, and stimulating social interaction and communication for people with dementia in the community. Methods: For the study, 40 community-dwelling older Chinese adults (≥60 years) with mild to moderate dementia will be recruited and randomly assigned to the PARO therapy group or the psychosocial activities control group. Both treatments consist of six, 30-minute weekly sessions, which will be conducted in a geriatric day hospital. Subjects in both groups will be assessed by a trained research assistant at baseline (pre-), during, and post-treatment. Mood (assessed with a simplified face scale), social interaction, and communication (ie, facial expressions and reactions towards each treatment, assessed with an observation table) will be the primary outcome measures. Secondary outcome measures will include assessments on cognitive function (Mini-Mental State Examination) and depressive symptoms (Cornell Scale for Depression in Dementia), as well as caregiver burden (Zarit Burden Inventory). Subjective impression towards each treatment and qualitative comments from the caregivers, facilitator, and therapists will also be obtained. Results: Recruitment to the pilot study began in 2014 and the last subject is expected to complete their post-treatment assessment in 2015. Conclusions: This will be the first RCT using PARO to improve mood, and stimulate social interaction and communication in the care of older people with dementia, as well as provide an evidence basis for the use of PARO in dementia care in Hong Kong. Trial Registration: The Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000037606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000037606 (Archived by WebCite at http://www.webcitation.org/6Xi7uXdu9).

  • Screenshots of the Online Wellbeing Centre website.

    Development of an Online Well-Being Intervention for Young People: An Evaluation Protocol

    Abstract:

    Background: Research has shown that improving well-being using positive mental health interventions can be useful for predicting and preventing mental illness. Implementing online interventions may be an effective way to reach young people, given their familiarity with technology. Objective: This study will assess the effectiveness of a website called the “Online Wellbeing Centre (OWC),” designed for the support and improvement of mental health and well-being in young Australians aged between 16 and 25 years. As the active component of the study, the OWC will introduce a self-guided app recommendation service called “The Toolbox: The best apps for your brain and body” developed by ReachOut.com. The Toolbox is a responsive website that serves as a personalized, ongoing recommendation service for technology-based tools and apps to improve well-being. It allows users to personalize their experience according to their individual needs. Methods: This study will be a two-arm, randomized controlled trial following a wait-list control design. The primary outcome will be changes in psychological well-being measured by the Mental Health Continuum Short Form. The secondary outcomes will be drawn from a subsample of participants and will include depression scores measured by the Center for Epidemiologic Studies Depression Scale, and quality of life measured by the Assessment of Quality of Life-four dimensions (AQOL-4D) index. Cost-effectiveness analysis will be conducted based on a primary outcome of cost per unique visit to the OWC. Utility-based outcomes will also be incorporated into the analysis allowing a secondary outcome to be cost per quality-adjusted life year gained (based on the AQOL-4D values). Resource use associated with both the intervention and control groups will be collected using a customized questionnaire. Online- and community-based recruitment strategies will be implemented, and the effectiveness of each approach will be analyzed. Participants will be recruited from the general Australian population and randomized online. The trial will last for 4 weeks. Results: Small but clinically significant increases in well-being symptoms are expected to be detected in the intervention group compared with the control group. Conclusions: If this intervention proves to be effective, it will have an impact on the future design and implementation of online-based well-being interventions as a valid and cost-effective way to support mental health clinical treatment. Findings regarding recruitment effectiveness will also contribute to developing better ways to engage this population in research. ClinicalTrial: This study is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000710628.

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  • Multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: design of a randomized controlled trial

    Date Submitted: May 21, 2015

    Open Peer Review Period: May 22, 2015 - Jun 5, 2015

    Background: Background: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing quality of life (QoL) and increasing morbidity and morta...

    Background: Background: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing quality of life (QoL) and increasing morbidity and mortality. For either single disease, a multidisciplinary disease-management approach supported by telecommunications technologies offers the best outcome in terms of prolonged survival and reduced hospital-readmissions. But no data exist in patients with combined COPD/CHF. Objective: Objective. We planned a randomized controlled trial to investigate the feasibility and efficacy of an integrated multidisciplinary telehealth home-based program versus conventional care in patients with coexisting CHF/COPD. The purpose of the paper is to the rationale and design of the trial. Methods: Methods: Patients, after inpatient rehabilitation, were randomly assigned to Intervention or Control, followed for 4 months at home, then assessed at 4 and 6 months. The intervention group followed a telesurveillance (phone-contacts by nurse and remote monitoring of cardiorespiratory parameters) and telerehabilitation home-based program (≥3 sessions/week of mini-ergometer, callisthenic exercises and twice weekly pedometer-driven walking, plus phone-contacts by physiotherapist). Telephone follow-up served to verify compliance to therapy, maintain exercise motivation, educate for early recognition of signs/symptoms, and verify the skills acquired. At baseline and 4 and 6 months, the 6-min walk test, dyspnea and fatigue at rest (Borg scale), oxygenation (PaO2/FiO2), physical activity profile (PASE questionnaire), and QoL (Minnesota and CAT questionnaires) were assessed. During the study, serious clinical events (hospitalizations or deaths) were recorded. Results: The data, currently being processed, will show whether telehealth management in combined COPD/CHF – complex, frail patients at high risk of exacerbations - is effective. Conclusions: Currently, no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF. Our study will show whether this approach is effective in the management of such complex, frail patients with very high risk of exacerbations. Clinical Trial: Trial registration: Clinical Trials NCT02269618

  • Guided Internet-based parent training for challenging behaviour in children with Fetal Alcohol Spectrum Disorder (Strongest FamiliesTM FASD): study protocol for a randomized controlled trial

    Date Submitted: May 21, 2015

    Open Peer Review Period: May 22, 2015 - Jun 5, 2015

    Background: Fetal Alcohol Spectrum Disorder (FASD) is a term used to encompass the full range of neurobehavioural and cognitive dysfunction that may occur as a consequence of prenatal alcohol exposure...

    Background: Fetal Alcohol Spectrum Disorder (FASD) is a term used to encompass the full range of neurobehavioural and cognitive dysfunction that may occur as a consequence of prenatal alcohol exposure. There is relatively little research on intervention strategies that specifically target the behavioural problems of children with FASD. Availability and access to services are barriers to timely and effective care for families. The Strongest Families FASD intervention was recently adapted from the Strongest FamiliesTM “Parenting the Active Child” program to include FASD specific content delivered via an internet-based application in conjunction with 11 telephone coaching sessions. Objective: 1) To evaluate the effectiveness of Strongest Families FASD in reducing externalizing problems [primary outcome], internalizing problems, and parent distress [secondary outcomes] in children aged between 4 and 12 years diagnosed with FASD when compared to a control group with access to a static resource webpage. 2) To evaluate the effectiveness of Strongest Families FASD in improving social competence [secondary outcome] in school-aged children aged between 6 and 12 diagnosed with FASD when compared to an online psychoeducation control. 3) To explore parental satisfaction with the Strongest Families FASD online parenting program. Methods: Parents and caregivers (n=200) of children diagnosed with FASD who have significant behavioural challenges, ages 4-12, are being recruited into a two-arm randomized trial. The trial is designed to evaluate the effectiveness of the web-based Strongest Families FASD parenting intervention on child behaviour and caregiver distress, compared to a control group receiving access to a static resource webpage (i.e., a list of FASD specific websites, readings, videos and organizations). Results: The primary outcome will be externalizing problems measured by the Child Behaviour Checklist (CBCL). Secondary outcomes include 1) internalizing problems and 2) social competence, both outcomes measured by the CBCL, 3) parental distress measured by the Depression Anxiety Stress Scale – 21. The Client Satisfaction Questionnaire (CSQ-8) and the Satisfaction Survey are completed by the intervention group at the end of session eleven. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials (CONSORT) Statement. Conclusions: It is hypothesized that the Strongest Families FASD intervention group will improve child behaviour and parental distress. Caregiver satisfaction is anticipated to be positive. Advancing evidence on the effectiveness and acceptance of distance services can inform policy and adoption of ehealth programs. Clinical Trial: (ClinicalTrials.gov Identifier) NCT02210455