2021 Fiscal Year Research-status Report
Nudging people with Type 2 diabetes towards sustained adherence to self-management: a cluster randomized controlled trial
| Project/Area Number |
20K18934
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| Research Institution | Hitotsubashi University |
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Principal Investigator |
Rouyard Thomas 一橋大学, 社会科学高等研究院, 特任助教 (40859542)
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| Project Period (FY) |
2020-04-01 – 2023-03-31
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| Keywords | type 2 diabetes / self-management / behavioural intervention / risk communication / heart age / primary care / cluster randomised trial |
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| Outline of Annual Research Achievements |
The study aims to evaluate the effects of a personalized behavioral intervention (‘FEEDBACK’) developed to improve self-management behavior in adults with type 2 diabetes. FEEDBACK is a resource-minimizing intervention designed to be delivered by general practitioners (GPs) in routine primary care settings. The study is a cluster randomized controlled trial (RCT) with six months follow-up.
In Japan, where the implementation of primary care policy has just begun, it is necessary to introduce evidence-based, person-centered diabetic care into the practice of GPs nationwide. If we could link our FEEDBACK intervention with improved patient outcomes and delivery in primary care, this would provide further justification for stronger primary care services and investment in primary care in Japan.
2021:
In line with the difficulties encountered in 2020, we have faced continued challenges and delays in our recruitment process (please see below). Despite considerable efforts, only 6 GP practices could be recruited to date, which corresponds to about 50 potential participants. We will pursue the efforts in 2022, hoping that recruitment will be eased as the detrimental effects of the COVID-19 pandemic recede. The study protocol will be submitted for publication as soon as we can estimate a realistic sample size, in collaboration with statisticians at the National University of Singapore. In parallel, we published an article to discuss the opportunities and challenges associated with using new types of non-coercive behavioral interventions such as FEEDBACK to promote healthier choices.
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| Current Status of Research Progress |
Current Status of Research Progress
4: Progress in research has been delayed.
Reason
In line with the difficulties encountered in 2020, we have faced continued challenges and delays in our recruitment process. For a large part, this has been due to the restrictions and additional burden imposed on GPs by the COVID-19 pandemic. However, we have also come to realize that Japanese GPs are generally not used to engage in clinical intervention research and may feel a little overwhelmed by it, which makes recruitment even more challenging. We hope that the recruitment process will be eased in 2022 as the detrimental effects of the COVID-19 pandemic recede, so that the trial can be completed as planned.
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| Strategy for Future Research Activity |
- If the planned sample size cannot be reached despite our recruitment efforts, or if the coefficient of variation in cluster size turns out to be much higher than expected (making the effective sample size too big given our budget constraint), we will consider the feasibility of opting for a cluster design with GPs, rather than GP practices, as the unit of randomization.
- We expect the study to be brought to the attention of a large international audience of clinicians and health policymakers. The manuscript describing the study protocol has now been finalized and will be submitted for publication as soon as we can estimate a realistic final sample size.
- Findings of the study will be disseminated to the largest possible audience through presentations at international conferences and publication in international peer-reviewed journals.
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| Causes of Carryover |
- Due to the delays imposed on our recruitment process, we have postponed the hiring of a research assistant (RA) who will be facilitating data collection at the clinical sites.
- Travels to attend international conferences and meetings, as well as
domestic meetings, have also been cancelled due to pandemic-related restrictions.
- We hope to be able to spend the funds as initially planned once recruitment will be completed: 1) RA wages, 2) travels to meetings and conferences, 3) compensation for volunteer GPs participating in the study.
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Research Products
(2 results)
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[Journal Article] Boosting healthier choices2022
Author(s)
Rouyard, T., Engelen, B., Papanikitas, A., & Nakamura, R.
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Journal Title
BMJ : British Medical Journal
Volume: 376
Pages: e064225
DOI
Peer Reviewed / Open Access / Int'l Joint Research
