NCT07241078

WhatsApp-Based and Family-Involved Diabetes Self-Management Education Study

The Effect of WhatsApp-Based and Family-Involved Self-Management Education and Support on HbA1c, Family Support, and Self-Management in Individuals With Type 2 Diabetes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Koç University · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effects of a WhatsApp-based and family-involved self-management education program on self-management, family support, and HbA1c levels among individuals with type 2 diabetes mellitus (T2DM). Hypotheses: * H1: There will be a significant difference in self-management scores between the intervention group receiving the WhatsApp-based and family-involved self-management education and the control group. * H2: There will be a significant difference in HbA1c levels between the intervention group receiving the WhatsApp-based and family-involved self-management education and the control group. * H3: There will be a significant difference in family support scores between the intervention group receiving the WhatsApp-based and family-involved self-management education and the control group. This randomized controlled trial will be conducted with 44 individuals diagnosed with T2DM who meet the inclusion criteria and one family member per participant (total 88 participants). Eligible patients will be randomly assigned to either the intervention or control group using a computer-generated randomization list. Participants (people with diabetes and their family members) in the intervention group will receive a 12-week, WhatsApp-based self-management education program. Educational modules (videos, visuals, and written materials) will be shared separately with each person with diabetes and their participating family member via WhatsApp twice a week. To reinforce learning, a five-question quiz will be sent separately to both the person with diabetes and the family member every Thursday. In addition, a brief follow-up phone call (approximately 10 minutes) will be conducted once a week only with the person with diabetes to review progress and provide feedback. Data collection will occur at baseline and at the end of the 12th week. Participants in the control group will continue their routine outpatient follow-ups for three months and complete the same measurement tools at baseline and post-intervention. Data will be collected using the Diabetic Participant Demographic Form, Family Member Demographic Form, Diabetes Self Management Questionnaire, Hensarling's Diabetes Family Support Scale, and the Diabetes Knowledge Scale for Adults. Statistical analyses will be performed using SPSS software. Group comparisons will be analyzed with independent t-tests or Mann-Whitney U tests, and pre-post comparisons with paired t-tests or Wilcoxon tests. A significance level of p\<0.05 will be used.

Detailed description

This randomized controlled trial investigates a 12-week WhatsApp-based self-management education program for adults with type 2 diabetes mellitus (T2DM) and one designated family member per participant. The program is delivered through mobile presentations-including videos, visuals, and text-based materials-sent separately to the person with diabetes and their family member twice weekly, on Mondays and Tuesdays. Weekly reinforcement is provided through a five-question quiz, sent individually to both participants every Thursday, and a brief (\~10-minute) telephone call with the person with diabetes on Friday or Saturday, according to their preference, to review weekly progress, provide feedback, and address challenges. The intervention aims to support adherence to self-care behaviors, enhance diabetes knowledge, and strengthen family involvement. Diabetic participants in the control group will continue their usual care, including routine physician appointments and consultations with a diabetes nurse if needed. Family members will maintain their normal daily activities without any structured intervention. Data collection occurs at baseline and after the 12-week intervention. The study employs standardized, validated instruments including the Diabetic Participant Demographic Form, Family Member Demographic Form, Diabetes Self Management Questionnaire, Hensarling's Diabetes Family Support Scale, and the Diabetes Knowledge Scale for Adults. Data Collection for Participants with Diabetes: * Baseline (Week 0): * Diabetic Participant Demographic Form * Diabetes Self-Management Questionnaire * Hensarling's Diabetes Family Support Scale * Diabetes Knowledge Scale for Adults * Post-intervention (Week 12): * Diabetes Self-Management Questionnaire * Hensarling's Diabetes Family Support Scale * Diabetes Knowledge Scale for Adults Data Collection for Family Members: * Baseline (Week 0): * Family Member Demographic Form * Diabetes Knowledge Scale for Adults * Post-intervention (Week 12): * Diabetes Knowledge Scale for Adults This study demonstrates a digitally-supported, family-involved intervention model, leveraging WhatsApp to increase accessibility, continuity, and sustainability of diabetes self-management practices. By delivering structured educational content, individualized feedback, and support from more knowledgeable family members, the program aims to enhance self-management behaviors and metabolic outcomes among adults with T2DM.

Conditions

• Diabetes Mellitus, Type 2
• Diabete Mellitus
• Diabetes Education
• Self-management

Interventions

Type	Name	Description
BEHAVIORAL	WhatsApp-based Family-Involved Diabetes Self-Management Education	Participants in the intervention group will receive a 12-week family-involved diabetes self-management education program delivered via WhatsApp. Education materials, including videos and visual guides, will be sent twice weekly (Monday and Tuesday) to both the diabetic participant and a designated family member. Participants will complete a 5-question quiz each Thursday to reinforce learning. Additionally, diabetic participants will have a weekly 10-minute phone call (Friday or Saturday) with the researcher to review progress and receive individualized feedback. Data collection will occur at baseline and at the end of the 12-week intervention using standardized forms and validated scales.
OTHER	Standard Care (in control arm)	Participants in the control group will continue their usual outpatient follow-up visits. This includes attending scheduled appointments with their physician and, if needed, consulting with the clinic's diabetes nurse. No additional educational intervention or structured self-management program will be provided. Data collection will occur at baseline (week 0) and at the end of week 12 using. Family members of control participants will also complete relevant forms at baseline and week 12.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Turkey (Türkiye)