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Effects of an Individual and Family Self-management support with Motivational Interviewing program on self-management behaviors and clinical outcomes among adults with diabetic retinopathy: A Randomized Controlled Trial

Effects of an Individual and Family Self-management support with Motivational Interviewing program on self-management behaviors and clinical outcomes among adults with diabetic retinopathy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250606005
Enrollment
108
Registered
2025-06-06
Start date
2024-01-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Adult patients who have type 2 diabetes mellitus and diabetic retinopathy complication. Individual and Family, Self-Management, Motivational Interviewing, Self-Management Behaviors, Diabetic Retinopathy

Interventions

Week 1: Pre-test: Samples: The Diabetes Self-Management Questionnaire (DSMQ), The Diabetes Family-Behavior Checklist version II, blood checking for HbA1C level, and checking fundus by fundus camera, P
Experimental Behavioral,No Intervention No treatment
Individual and Family Self-Management support with Motivational Interviewing program : Experimental group,Comparison

Sponsors

Thammasat University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
23 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. The samples who Being aged between 23-59 years, 2. Diagnosed with type 2 Diabetes Mellitus and moderate to severe non-proliferative diabetic retinopathy by the level of the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale between 43 and 53, 3. HbA1C level more than 7% at least 2 consecutive times before entering the program, 4.Using only oral medication to control blood sugar level, 5.Having smartphone or tablet, 6. Be able to use Line application, and 7.Can be communicate, read, and write in Thai, 8. Inclusion criteria for family members are person who being aged more than 18 years, 9. Living in the same household with the samples and being primary caregiver, and 10. Can be communicate, read, write in Thai

Exclusion criteria

Exclusion criteria: 1. The samples who have severe complications or severe other conditions which make them unable to participate in the program, such as heart failure, diabetes crisis, and end stage renal disease, 2. Receiving diabetic retinopathy treatment such as laser therapy, anti VEGF drugs, and intraocular surgery within 6 months

Design outcomes

Primary

MeasureTime frame
The diabetes self-management questionnaire (DSMQ) baseline (week 1), week 16, week 24 Likert scale 1-5,The Diabetes Family-Behavior Checklist version II (DFBC II) baseline (week 1), week 16, week 24 Likert scale 1-5,The Diabetes knowledge questionnaire (DKQ) baseline (week1), week 16, week 24 Dichotomous scale (Right/Wrong)

Secondary

MeasureTime frame
HbA1C level baseline (week 1), week 24 Percent,The Early Treatment Diabetic Retinopathy Study (ETDRS) scale baseline (week1), week 24 Report fundus photograph into 13 numbered levels

Countries

Thailand

Contacts

Public ContactPrasanee Pankasikorn

Faculty of Nursing, Thammasat University

prasaneepan@gmail.com029869213

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026