Ireland
--:--IST
Starting soon Not applicable

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

NCT07241078 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11
Last updated
2025-11-21

Condition(s) studied

Diabetes Mellitus, Type 2Diabete MellitusDiabetes EducationSelf-management

Investigational drug(s) / intervention(s)

WhatsApp-based Family-Involved Diabetes Self-Management EducationStandard Care (in control arm)

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria: People diagnosed with type 2 diabetes at least six months prior, receiving insulin and/or oral antidiabetic therapy, with an HbA1c value of 7% or higher, capable of communicating in Turkish, literate, and possessing the ability to use a smartphone and WhatsApp, as well as having internet access. Participants are required to agree to participate together with a family member who can provide support related to diabetes. Family members involved in the intervention are expected to be able to communicate in Turkish, literate, able to use a smartphone and WhatsApp, have internet access, and reside within reach of the participant with diabetes. \- Exclusion Criteria: Individuals will be excluded if they have type 1 diabetes or gestational diabetes, severe cognitive impairment, advanced visual or hearing loss, any condition preventing the use of digital platforms, or communication or language barriers that would hinder participation. Family members will be excluded if they have diabetes, cognitive impairment, advanced visual or hearing loss, inability to use digital tools, or communication and language barriers. \-

Primary outcome measure(s)

  • HbA1c Level — Baseline (week 0) and 12 weeks
    HbA1c values will be obtained from participants' medical records or recent laboratory results. HbA1c reflects average blood glucose levels over the past 2-3 months. Values are reported as percentages, with higher percentages indicating poorer glycemic control.
  • Diabetes Self-Management — Baseline (week 0) and 12 weeks
    Measured using the Diabetes Self-Management Scale to evaluate participants' self-management behaviors. Higher scores indicate better self-management behaviors.
  • Family Support — Baseline (week 0) and 12 weeks
    Perceived family support in diabetes management will be assessed using Hensarling's Diabetes Family Support Scale (HDFSS). The scale includes 24 items across 4 subscales and uses a 5-point Likert response format, where higher scores indicate greater perceived family support.

Trial sites (1)

FacilityCityRegionStatus
Koç University Hospital Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07241078 on ClinicalTrials.gov ↗ ← All trials in Turkey