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NCT Number: NCT07241078

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

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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University Hospital

Istanbul, Turkey (Türkiye)

Location contact

Aleyna Özkan, PhD Student

CONTACT

[email protected]

+90 538 545 70 89

Aleyna Özkan, PhD Student

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

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Treatment and study plan

WhatsApp-based Family-Involved Diabetes Self-Management Education

Behavioral

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)

Other

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.

Primary outcomes

  1. HbA1c Level

    Time frame: 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.

  2. Diabetes Self-Management

    Time frame: 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.

  3. Family Support

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleyna Özkan, PhD Candidate

CONTACT

[email protected]

+90 538 545 70 89

Meryem Yıldız Ayvaz, Dr.

CONTACT

[email protected]

+90 554 379 83 73

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

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

Acronym: WAF-DSMES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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