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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-UMIN000049643
Enrollment
264
Registered
2022-11-29
Start date
2022-10-31
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) Communication of CV risk: The increased CV risk probability will be communicated to patients using the risk metric &quot
2) Physician delivered risk reduction discussion: The physician and the patient will discuss a personalized, realistic risk reduction objective that is achievable by the time of the next consultation

Sponsors

Department of General Practice, Kashima Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 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) 2) Patients whose HbA1c>= 7.0% at the last routine clinical check 3) Patients who are able to complete the self-administered questionnaire 4) Patient who are able to understand the materials explaining about this study and agree in writing

Exclusion criteria

Exclusion criteria: 1) Insulin users 2) Co-morbidities or disorders incompatible with T2D self-care behaviours at the time of the study 3) Learning or communication difficulties

Design outcomes

Primary

MeasureTime frame
Change in HbA1c levels at 6 months

Secondary

MeasureTime frame
1) Perceptions of cardiovascular (CV) risk 2) Psychological responses to CV risk 3) CV risk score reliability 4) Intentions to change behaviour 5) Shared decision-making 6) Provider communication satisfaction 7) Self-efficacy 8) Change in prescription of therapeutic drugs 9) Self-management score 10) CV event risk communication 11) Achievement of glycaemic control goal

Countries

Japan

Contacts

Public ContactMei Endo

Hoshi Yokozuka Clinic Department of Family Practice

nakame08157@yahoo.co.jp0249567778

Outcome results

None listed

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