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Improving risk communication in Type 2 diabetics to initiate self-management behaviour change

Fukushima Study for Engaging People with Type 2 Diabetes in Behaviour Associated Change (FEEDBACK): A cluster randomised controlled trial in primary care - FEEDBACK Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043928
Enrollment
264
Registered
2021-04-14
Start date
2021-04-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Intervention arm 1) Risk communication of CV risk by using &quot
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, rese
Risk Score&quot
calculated as probability 2) None 3) Standard lifestyle reviews and provision of behavioural change information 4) None 5) None

Sponsors

Graduate School of Biomedical and Health Sciences, Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Insulin users Co-morbidities or disorders incompatible with T2D self-care behaviours at the time of the study Learning or communication difficulties

Design outcomes

Primary

MeasureTime frame
Change in HbA1c score

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactSatoshi Kanke

Kitakata City Centre for Community and Family Medicine Department of Family Medicine

satoshi.kanke@gmail.com+81241245320

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026