Unique ID issued by UMIN | UMIN000043928 |
---|---|
Receipt number | R000049369 |
Scientific Title | Fukushima Study for Engaging People with Type 2 Diabetes in Behaviour Associated Change (FEEDBACK): A cluster randomised controlled trial in primary care |
Date of disclosure of the study information | 2021/04/14 |
Last modified on | 2022/10/25 14:24:30 |
Improving risk communication in Type 2 diabetics to initiate self-management behaviour change
FEEDBACK Study
Fukushima Study for Engaging People with Type 2 Diabetes in Behaviour Associated Change (FEEDBACK): A cluster randomised controlled trial in primary care
FEEDBACK Study
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism | Adult |
Others
NO
To reveal the effects of newly developed interventions based on behavioral science findings on disease control and behavioral and psychological aspects of patients with type 2 diabetes who visit a primary care outpatient clinic.
Safety,Efficacy
Change in HbA1c score
1) Perceptions of cardiovascular (CV) risk
2) Psychological reaction to CV risk
3) Reliability of CV risk score
4) Intentions to change behaviour
5) Shared decision-making
6) Provider communication satisfaction
7) Self-efficacy score
8) Change in prescription of therapeutic drug
9) Self-management score
10) Risk communication for CV events
11) Achievement of glycemic control goal
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Other |
Intervention arm
1) Risk communication of CV risk by using "Heart Age"
2) Goal setting by consensus between the doctor and patient
3) Action plans setting by consensus between the doctor and patient
4) Active participation in the action plans
5) Reassess CV risk, reset the goal and action plans
Control arm
1) Risk communication of CV risk by using "Risk Score" calculated as probability
2) None
3) Standard lifestyle reviews and provision of behavioural change information
4) None
5) None
20 | years-old | <= |
70 | years-old | > |
Male and Female
Patients who have been diagnosed with Type 2 Diabetes (T2D) (diagnosis based on 2 recorded diagnostic-level tests, based on HbA1c and/or blood glucose)
Patients whose HbA1c>= 7.0% at the last routine clinical check
Patients who are able to complete the self-administered questionnaire
Patient who are able to understand the materials explaining about this study and agree in writing
Insulin users
Co-morbidities or disorders incompatible with T2D self-care behaviours at the time of the study
Learning or communication difficulties
264
1st name | Michiko |
Middle name | |
Last name | Moriyama |
Hiroshima University
Graduate School of Biomedical and Health Sciences
734-8551
Kasumi 1-2-3 Minami-ku, Hiroshima
+81822575365
morimich@hiroshima-u.ac.jp
1st name | Satoshi |
Middle name | |
Last name | Kanke |
Kitakata City Centre for Community and Family Medicine
Department of Family Medicine
966-0083
Rokumaiosa 4212, Kitakata, Fukushima
+81241245320
satoshi.kanke@gmail.com
Graduate School of Biomedical and Health Sciences, Hiroshima University
Grants-in-Aid for Scientific Research
Other
Ethical Committee for Clinical Research of Hiroshima University
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
+81 82 257 1551
iryo-seisaku@office.hiroshima-u.ac.jp
NO
只見町国民健康保険朝日診療所(福島県)、保原中央クリニック(福島県)、喜多方市 地域・家庭医療センター(福島県)、ほし横塚クリニック(福島県)、医療法人北海道家庭医療学センター(北海道)
Tadami Town National Health Insurance Asahi Clinic (Fukushima), Hobara Central Clinic (Fukushima), Kitakata Centre for Community and Family Medicine (Fukushima), Hoshi Yokozuka Clinic (Fukushima), The Hokkaido Centre for Family Medicine (Hokkaido)
2021 | Year | 04 | Month | 14 | Day |
Unpublished
Terminated
2021 | Year | 01 | Month | 18 | Day |
2021 | Year | 04 | Month | 14 | Day |
2021 | Year | 04 | Month | 14 | Day |
2022 | Year | 07 | Month | 31 | Day |
2021 | Year | 04 | Month | 14 | Day |
2022 | Year | 10 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049369
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