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

NCT07241078 | Not Yet Recruiting

• 1 other identifier: 2025.332.IRB2.154
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

diabetes; family involved; WhatsApp based; family support; HbA1c; self management; type 2 diabetes

Outcome Measures

Primary Outcomes (3)

• HbA1c Level

  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.

  Baseline (week 0) and 12 weeks

• Diabetes Self-Management

  Measured using the Diabetes Self-Management Scale to evaluate participants' self-management behaviors. Higher scores indicate better self-management behaviors.

  Baseline (week 0) and 12 weeks

• Family Support

  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.

  Baseline (week 0) and 12 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

22 adults with type 2 diabetes and their 22 family members will receive a 12-week WhatsApp-supported, family-involved diabetes self-management education program.

Behavioral: WhatsApp-based Family-Involved Diabetes Self-Management Education

Control arm

OTHER

22 adults with type 2 diabetes and their 22 family members will continue standard outpatient care for 12 weeks, according to their routine clinic appointments.

Other: Standard Care (in control arm)

Interventions

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.

Intervention arm

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.

Control arm

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Walker RJ, Gebregziabher M, Martin-Harris B, Egede LE. Understanding the influence of psychological and socioeconomic factors on diabetes self-care using structured equation modeling. Patient Educ Couns. 2015 Jan;98(1):34-40. doi: 10.1016/j.pec.2014.10.002. Epub 2014 Oct 22.

  PMID: 25455793 BACKGROUND

• Vongmany J, Luckett T, Lam L, Phillips JL. Family behaviours that have an impact on the self-management activities of adults living with Type 2 diabetes: a systematic review and meta-synthesis. Diabet Med. 2018 Feb;35(2):184-194. doi: 10.1111/dme.13547. Epub 2017 Dec 8.

  PMID: 29150863 BACKGROUND

• Association of Diabetes Care and Education Specialists; Kolb L. An Effective Model of Diabetes Care and Education: The ADCES7 Self-Care Behaviors. Sci Diabetes Self Manag Care. 2021 Feb;47(1):30-53. doi: 10.1177/0145721720978154.

  PMID: 34078208 BACKGROUND

• Nkhoma DE, Soko CJ, Bowrin P, Manga YB, Greenfield D, Househ M, Li Jack YC, Iqbal U. Digital interventions self-management education for type 1 and 2 diabetes: A systematic review and meta-analysis. Comput Methods Programs Biomed. 2021 Oct;210:106370. doi: 10.1016/j.cmpb.2021.106370. Epub 2021 Aug 26.

  PMID: 34492544 BACKGROUND

• Bekele BB, Negash S, Bogale B, Tesfaye M, Getachew D, Weldekidan F, Balcha B. Effect of diabetes self-management education (DSME) on glycated hemoglobin (HbA1c) level among patients with T2DM: Systematic review and meta-analysis of randomized controlled trials. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):177-185. doi: 10.1016/j.dsx.2020.12.030. Epub 2020 Dec 19.

  PMID: 33360516 BACKGROUND

• Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Lernmark A, Metzger BE, Nathan DM, Kirkman MS. Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus. Diabetes Care. 2023 Oct 1;46(10):e151-e199. doi: 10.2337/dci23-0036.

  PMID: 37471273 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Meryem Yıldız Ayvaz

  Koç University

  STUDY DIRECTOR

Central Study Contacts

Aleyna Özkan, PhD Candidate

CONTACT

+90 538 545 70 89; aleynaozkan16@ku.edu.tr

Meryem Yıldız Ayvaz, Dr.

CONTACT

+90 554 379 83 73; mayvaz@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Findings from this study are anticipated to be made available through publication within two years and will remain accessible indefinitely.
• Access Criteria: Following publication, researchers working on diabetes will be able to access the study findings via the published reports.

Locations

TU (1)