| 研究課題/領域番号 |
20K18934
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| 研究機関 | 一橋大学 |
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研究代表者 |
Rouyard Thomas 一橋大学, 社会科学高等研究院, 特任助教 (40859542)
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| 研究期間 (年度) |
2020-04-01 – 2022-03-31
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| キーワード | type 2 diabetes / self-management / behavioural intervention / risk communication / heart age / primary care / cluster randomised trial |
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| 研究実績の概要 |
The study aims to evaluate the effects of a personalised behavioural intervention (‘FEEDBACK’) developed to improve self-management behaviour in adults with type 2 diabetes. FEEDBACK is a resource-minimising intervention designed to be delivered by general practitioners (GPs) in routine primary care settings. The study is a cluster randomised 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-centred 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.
2020:
Study design and intervention have been refined following presentation of the planned protocol at an international conference; International collaboration has been strengthened: two medical statisticians from the National University of Singapore have joined the research team; Finalized study protocol has been granted ethical approval by the Research Ethics Committee of Hiroshima University; A manuscript of the finalized protocol is currently under preparation for submission for publication in an international peer-reviewed journal; Recruitment of clusters (general practices) has started in Fukushima and Hokkaido prefecture. We have been facing challenges and delays in the recruitment process due to the restrictions and additional burden imposed on GPs by the COVID-19 pandemic.
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| 現在までの達成度 (区分) |
現在までの達成度 (区分)
4: 遅れている
理由
The start of the study has been delayed. We have been facing challenges in the recruitment process due to the restrictions and additional burden imposed on GPs by the management of the COVID-19 pandemic. Despite these difficulties, recruitment of GP practices has started in Fukushima and Hokkaido prefecture. We hope to be able to complete the recruitment process by the second half of 2021.
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| 今後の研究の推進方策 |
- The action plan has not changed.
- If the planned number of GP practices cannot be recruited due to COVID-19 restrictions, 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 opting for a cluster design with providers, rather than practices, as the unit of randomisation.
- We expect the study to be brought to the attention of a large international audience of clinicians and health policymakers. A manuscript of the finalized protocol is currently under preparation for submission for publication in an international peer-reviewed journal.
- Findings of the study will also be disseminated to the largest possible audience through presentations at international conferences and publication in international peer-reviewed journals.
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| 次年度使用額が生じた理由 |
Due to the delays imposed on our recruitment process by the COVID-19 pandemic, we have postponed the hiring of a research assistant (RA) who will be facilitating data collection at the clinical sites. Moreover, 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) travels to meetings and conferences, 2) RA wages, 3) compensation for volunteer GPs participating in the study (additional time spent with patients + administrative burden associated with data collection).
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| 備考 |
A manuscript of the finalized protocol is currently under preparation for submission for publication in an international peer-reviewed journal.
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