2022 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
|
|---|
| Research Institution | Hitotsubashi University |
|---|
Principal Investigator |
Rouyard Thomas 一橋大学, 社会科学高等研究院, 特任講師 (40859542)
|
|---|
| Project Period (FY) |
2020-04-01 – 2024-03-31
|
| Keywords | type 2 diabetes / self-management / behavioural intervention / risk communication / heart age / primary care / cluster randomised trial |
|---|
| 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.
2022:
- After numerous study implementation challenges and delays encountered in 2020 and 2021 due to the COVID-19 pandemic, we have now managed to make good progress in the recruitment process. Eighteen GP practices have been recruited so far, which is close to our initial sample size objective (n=20). We would like to recruit a few more practices to ensure that our pre-registered minimum effect size of interest can be detectable.
- As we made good process on the recruitment process, we submitted the study protocol for publication in an international peer-reviewed journal in January 2023. The manuscript has been accepted for publication in the journal 'Trials'.
|
| Current Status of Research Progress |
Current Status of Research Progress
4: Progress in research has been delayed.
Reason
For a large part, the project's delay has been due to the restrictions and additional burden imposed on GPs by the COVID-19 pandemic. However, as indicated in last year's report, 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 has made the recruitment process even more challenging. Despite these challenges, our efforts have eventually paid off and we are confident that we will complete recruitment by September 2023.
|
| Strategy for Future Research Activity |
- Once recruitment is completed, we will start the intervention period. We are confident that this will be implemented in the second half of 2023.
- We expect the study to be brought to the attention of a large international audience of clinicians and health policymakers. Findings of the study will be disseminated to the largest possible audience through presentations at international conferences and publication in international peer-reviewed journals.
|
| 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.
- Once recruitment will be fully completed, we will spend the funds as planned: 1) RA wages, 2) compensation for participants in the study, 3) processing charges for manuscripts acccepted for publication
|
Research Products
(1 results)
-
[Journal Article] Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial2023
Author(s)
Rouyard T, Endo M, Nakamura R, Moriyama M, Stanyon M, Kanke S, Nakamura K, Chen C, Hara Y, Ii M, Kassai R
-
Journal Title
Trials
Volume: 24
Pages: 1-15
DOI
Peer Reviewed / Open Access / Int'l Joint Research
