Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes

Johnson, Steven T.; Mundt, Clark; Soprovich, Allison; Wozniak, Lisa; Plotnikoff, Ronald C.; Johnson, Jeffrey

doi:10.1186/1471-2458-12-455

Cited by 18 publications

(21 citation statements)

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“…We have described the HEALD intervention elsewhere (17). Briefly, HEALD was a 6-month ES-led, pedometer-based walking intervention for people with type 2 diabetes.…”

Section: Heald Intervention Training and Qualificationsmentioning

confidence: 99%

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Contextualizing the Proven Effectiveness of a Lifestyle Intervention for Type 2 Diabetes in Primary Care: A Qualitative Assessment Based on the RE-AIM Framework

Wozniak

Soprovich

Mundt

et al. 2015

Canadian Journal of Diabetes

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“…We have described the HEALD intervention elsewhere (17). Briefly, HEALD was a 6-month ES-led, pedometer-based walking intervention for people with type 2 diabetes.…”

Section: Heald Intervention Training and Qualificationsmentioning

confidence: 99%

“…Our goal was to determine its overall effectiveness in Alberta's community-based settings (17). HEALD was a 6-month exercise specialist (ES)-led, pedometerbased walking intervention for people with type 2 diabetes that had previously proven to be efficacious (18).…”

Section: Introductionmentioning

confidence: 99%

Contextualizing the Proven Effectiveness of a Lifestyle Intervention for Type 2 Diabetes in Primary Care: A Qualitative Assessment Based on the RE-AIM Framework

Wozniak

Soprovich

Mundt

et al. 2015

Canadian Journal of Diabetes

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“…The design and rationale for controlled evaluations of the effectiveness of the two ABCD pilot interventions have been described elsewhere 8 9. The primary outcome of HEALD-PCN is improvement in physical activity (ie, brisk walking), determined by step pedometers and self-report 8. For TeamCare-PCN, the primary outcome is improvement of depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) items 9.…”

Section: Methods and Analysismentioning

confidence: 99%

Applying the RE-AIM framework to the Alberta's Caring for Diabetes Project: a protocol for a comprehensive evaluation of primary care quality improvement interventions

et al. 2012

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IntroductionDiabetes represents a major public health and health system burden. As part of the Alberta's Caring for Diabetes (ABCD) Project, two quality-improvement interventions are being piloted in four Primary Care Networks in Alberta. Gaps between health research, policy and practice have been documented and the need to evaluate the impact of public health interventions in real-world settings to inform decision-making and clinical practice is paramount. In this article, we describe the application of the RE-AIM framework to evaluate the interventions beyond effectiveness.Methods and analysisTwo quality-improvement interventions were implemented, based on previously proven effective models of care and are directed at improving the physical and mental health of patients with type-2 diabetes. Our goal is to adapt and apply the RE-AIM framework, using a mixed-methods approach, to understand the impact of the interventions to inform policy and clinical decision-making. We present the proposed measures, data sources and data management and analysis strategies used to evaluate the interventions by RE-AIM dimension.Ethics and disseminationEthics approval for the ABCD Project has been granted from the Health Research Ethics Board (HREB #PRO00012663) at the University of Alberta. The RE-AIM framework will be used to structure our dissemination activities by dimension.ResultsIt will be presented at relevant conferences and prepared for publication in peer-reviewed journals. Various products, such as presentations, briefing reports and webinars, will be developed to inform key stakeholders of the findings. Presentation of findings by RE-AIM dimension will facilitate discussion regarding the public health impact of the two interventions within the primary care context of Alberta and lessons learned to be used in programme planning and care delivery for patients with type-2 diabetes. It will also promote the application of evaluation models to better assess the impact of community-based primary healthcare interventions through our dissemination activities.

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“…l reviews of self-management and diabetes (n = 10) 24,25,[58][59][60][61][62][63][64][65] l individual self-management programmes or interventions (n = 22) l research protocols describing individual self-management interventions (n = 8) [88][89][90][91][92][93][94][95] l observational studies reporting influences on self-management -barriers and enablers (n = 31). [29][30][31][32][33] Initially, we extracted data from the papers that described the form or content of self-management.…”

Section: Phases I and Iimentioning

confidence: 99%

Managing with Learning Disability and Diabetes: OK-Diabetes – a case-finding study and feasibility randomised controlled trial

House

Bryant

Russell

et al. 2018

Health Technol Assess

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BackgroundObesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population.ObjectivesTo develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU).DesignObservational study and an individually randomised feasibility RCT.SettingThree cities in West Yorkshire, UK.ParticipantsIn the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA1c) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m2or self-reported physical activity below national guideline levels.InterventionsStandardised SSM. TAU supported by an easy-read booklet.Main outcome measures(1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA1c, BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention.ResultsIn the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA1clevel was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7.1%, SD 1.4%]. The BMI of 65% of participants was > 30 kg/m2and of 21% was > 40 kg/m2. Many participants reported low mood, dissatisfaction with lifestyle and diabetes management and an interest in change. Non-response rates were high (45/147, 31%) for medical data requested from the primary care team. In the RCT, 82 participants were randomised. The mean baseline HbA1clevel was 56 mmol/mol (SD 16.5 mmol/mol; 7.3%, SD 1.5%) and the mean BMI was 34 kg/m2(SD 7.6 kg/m2). All SSM sessions were completed by 35 out of 41 participants. The adherence measure was obtained in 37 out of 41 participants. The follow-up HbA1clevel and BMI was obtained for 75 out of 82 (91%) and 77 out of 82 (94%) participants, respectively. Most participants reported a positive experience of the intervention. A low response rate and difficulty understanding the EuroQol-5 Dimensions were challenges in obtaining data for an economic analysis.LimitationsWe recruited from only 60% of eligible general practices, and 90% of participants were on a general practice learning disability register, which meant that we did not recruit many participants from the wider population with milder learning disability.ConclusionsA definitive RCT is feasible and would need to recruit 194 participants per arm. The main barrier is the resource-intensive nature of recruitment. Future research is needed into the effectiveness of obesity treatments in this population, particularly estimating the longer-term outcomes that are important for health benefit. Research is also needed into improving ways of assessing quality of life in adults with a learning disability.Trial registrationCurrent Controlled Trials ISRCTN41897033.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 26. See the NIHR Journals Library website for further project information.

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Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes

Cited by 18 publications

References 47 publications

Contextualizing the Proven Effectiveness of a Lifestyle Intervention for Type 2 Diabetes in Primary Care: A Qualitative Assessment Based on the RE-AIM Framework

Contextualizing the Proven Effectiveness of a Lifestyle Intervention for Type 2 Diabetes in Primary Care: A Qualitative Assessment Based on the RE-AIM Framework

Applying the RE-AIM framework to the Alberta's Caring for Diabetes Project: a protocol for a comprehensive evaluation of primary care quality improvement interventions

Managing with Learning Disability and Diabetes: OK-Diabetes – a case-finding study and feasibility randomised controlled trial

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