UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Improving risk communication in Type 2 diabetics to initiate self-management behaviour change
Acronym
FEEDBACK Study
Scientific Title
Fukushima Study for Engaging People with Type 2 Diabetes in Behaviour Associated Change (FEEDBACK): A cluster randomised controlled trial in primary care
Scientific Title:Acronym
FEEDBACK Study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c score
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
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
Interventions/Control_2
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
Insulin users
Co-morbidities or disorders incompatible with T2D self-care behaviours at the time of the study
Learning or communication difficulties
Target sample size
264
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Moriyama |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
+81822575365
morimich@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kanke |
Organization
Kitakata City Centre for Community and Family Medicine
Division name
Department of Family Medicine
Zip code
966-0083
Address
Rokumaiosa 4212, Kitakata, Fukushima
TEL
+81241245320
Homepage URL
satoshi.kanke@gmail.com
Sponsor or person
Institute
Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel
+81 82 257 1551
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049369
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