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Diabetes Mellitus, Type 2WAF-DSMESNCT07241078

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

A study testing WhatsApp-based Family-Involved Diabetes Self-Management Education in people with Diabetes Mellitus, Type 2 and Diabete Mellitus, run by Koç University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 74 years
What is being tested?
WhatsApp-based Family-Involved Diabetes Self-Management Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteTurkey (Türkiye)
Study dates
Nov 2025to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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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Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Turkey (Türkiye)1 site
  • Koç University Hospital

    Istanbul

    Aleyna Özkan, PhD Student, +90 538 545 70 89, aleynaozkan16@ku.edu.tr

    Aleyna Özkan, PhD Student

Other trials in Turkey (Türkiye)

About this study

Official 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

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:

Read more
  • 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.

Read the 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.

Being tested
WhatsApp-based Family-Involved Diabetes Self-Management Education, Standard Care (in control arm)
Keywords
diabetes, family involved, WhatsApp based, family support, HbA1c, self management, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WhatsApp-based Family-Involved Diabetes Self-Management EducationBehavioural

    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.

Study groups in NCT07241078
Study groupRoleWhat they receive
Intervention armExperimental22 adults with type 2 diabetes and their 22 family members will receive a 12-week WhatsApp-supported, family-involved diabetes self-management education program.
Receives: Behavioral: WhatsApp-based Family-Involved Diabetes Self-Management Education
Control armOther22 adults with type 2 diabetes and their 22 family members will continue standard outpatient care for 12 weeks, according to their routine clinic appointments.
Receives: Other: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (week 0) and 12 weeks

  2. Diabetes Self-Management

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

    Measured: Baseline (week 0) and 12 weeks

  3. 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.

    Measured: Baseline (week 0) and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study startNov 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07241078
Sponsor's protocol ID
2025.332.IRB2.154
Acronym
WAF-DSMES
Status last verified
Oct 2025
First submitted
16 Nov 2025
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Results from this study will be shared with the scientific community through peer-reviewed publications.

Publications

  • 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.

    PubMed 25455793
  • 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.

    PubMed 29150863
  • 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.

    PubMed 34078208
  • 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.

    PubMed 34492544
  • 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.

    PubMed 33360516
  • 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.

    PubMed 37471273

Questions about this trial

What is this clinical trial studying?

A study testing WhatsApp-based Family-Involved Diabetes Self-Management Education in people with Diabetes Mellitus, Type 2 and Diabete Mellitus, run by Koç University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleyna Özkan, PhD Candidate (+90 538 545 70 89, aleynaozkan16@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c Level (time frame: Baseline (week 0) and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07241078, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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