NCT07207694

Brief Summary

Stroke is one of the leading causes of death and disability worldwide, with type 2 diabetes mellitus (T2DM) being a major risk factor that doubles the risk of ischemic stroke. Glycemic dysregulation is observed in nearly two-thirds of patients after acute stroke and is associated with both the severity of the initial cerebrovascular event and the risk of recurrence. Effective glycemic control, patient education, and adherence to treatment are therefore critical for secondary stroke prevention and improved patient outcomes. Mobile health technologies, particularly social media applications, have become increasingly important in supporting chronic disease management. WhatsApp-based education has been shown to improve self-efficacy, self-management, and diabetes knowledge in patients with T2DM. However, there is a limited number of studies investigating the effect of WhatsApp-supported education and counseling on stroke patients with T2DM, especially regarding healthy lifestyle behaviors, glycemic control, and disease-related knowledge. This randomized controlled trial aims to evaluate the effect of WhatsApp-supported education and counseling on healthy lifestyle behaviors, glycemic control, and knowledge levels among stroke patients receiving insulin therapy. Participants will be randomly assigned to either the intervention group or the control group. The control group will receive routine face-to-face diabetes education and insulin injection training during hospitalization. The intervention group will receive the same routine education plus a structured WhatsApp-based diabetes education program over four weeks. Educational content will include videos, photos, and booklets focusing on diabetes definition and symptoms, complications, hypoglycemia and hyperglycemia management, foot care, nutrition, exercise, oral antidiabetic and insulin therapy, and insulin injection demonstration. Participants' questions will be answered through WhatsApp messages, supporting continuous learning and adherence after discharge. A total of 84 participants (42 per group) will be included, based on power analysis with a 5% significance level, 95% power, and accounting for a 10% dropout rate. Randomization will be conducted using block randomization with six combinations via an independent researcher through an online randomization tool. Data will be collected at baseline (T0) and six months after the intervention (T1). The primary outcomes include diabetes knowledge measured by the Revised Diabetes Knowledge Test-2, healthy lifestyle behaviors assessed using the Healthy Lifestyle Behavior Scale, and glycemic control parameters (fasting glucose, fasting insulin, HbA1c, and HOMA-IR). All assessments will be performed by a trained nurse in the stroke clinic. Data analysis will include descriptive statistics, parametric or non-parametric tests depending on distribution, and reliability analyses using Cronbach's alpha. Ethical approval has been obtained from the Ethics Committee of SBÜ Gaziler Physical Training and Rehabilitation Research Hospital (Approval No: E-34215015). This study is expected to demonstrate that WhatsApp-supported education and counseling improve patient knowledge, promote healthy lifestyle behaviors, and enhance glycemic control in stroke patients with T2DM. These findings may support the integration of digital counseling interventions into rehabilitation programs for secondary prevention and long-term disease management.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Oct 2025Nov 2026

First Submitted

Initial submission to the registry

September 25, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

October 6, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

September 25, 2025

Last Update Submit

October 2, 2025

Conditions

Keywords

Healthy Lifestyle Behaviorstype 2 diabetes mellitusstroke

Outcome Measures

Primary Outcomes (6)

  • Change in Diabetes Knowledge

    Assessed using the Revised Diabetes Knowledge Test-2 (23 items). Scores range from 0 to 23, with higher scores indicating greater diabetes knowledge.

    Baseline (T0) and 6 months after intervention (T1)

  • Change in HbA1c

    Laboratory value HbA1c (%). Lower levels indicate better glycemic control.

    Baseline (T0) and 6 months after intervention (T1)

  • Change in Healthy Lifestyle Behaviors

    Measured by the Healthy Lifestyle Behavior Scale (34 items, 5-point Likert). Scores range from 0-100, with higher scores reflecting healthier lifestyle behaviors

    Baseline (T0) and 6 months after intervention (T1)

  • Change in fasting glucose

    Laboratory value: fasting glucose (mg/dL). Measurement of blood glucose levels after at least 8 hours of fasting. Lower values indicate better glycemic control.

    Baseline (T0) and 6 months after intervention (T1)

  • Change in fasting insulin

    Laboratory value: fasting insulin (µIU/mL). Measurement of circulating insulin levels after at least 8 hours of fasting. Lower levels indicate improved insulin sensitivity and better glycemic control.

    Baseline (T0) and 6 months after intervention (T1)

  • Change in HOMA-IR

    Laboratory value: HOMA-IR (Homeostatic Model Assessment of Insulin Resistance). Calculated from fasting glucose and fasting insulin using the formula: HOMA-IR=Fasting Glucose (mg/dL)×Fasting Insulin (µIU/mL):405 Higher values indicate greater insulin resistance, whereas lower values reflect better glycemic control.

    Baseline (T0) and 6 months after intervention (T1)

Study Arms (2)

control group

ACTIVE COMPARATOR

Participants in the control group will receive routine face-to-face diabetes education and insulin injection training provided during hospitalization. The education is delivered verbally to patients and their caregivers by the clinical staff. After the follow-up period and data collection are completed, participants in the control group will also be offered access to the WhatsApp-based educational materials used in the intervention group.

Behavioral: Active Comparator: Routine Education

WhatsApp-based education group

EXPERIMENTAL

Participants in the intervention group will receive the same routine face-to-face diabetes education and insulin injection training as the control group, plus a structured WhatsApp-based educational program. The WhatsApp intervention will be delivered over four weeks and include booklets/brochures, photos, and videos on diabetes definition and symptoms, complications, recognition and management of hypoglycemia and hyperglycemia, foot care, nutrition, exercise, oral antidiabetic and insulin therapy, and insulin injection demonstration. Participants' questions will be answered through WhatsApp to provide interactive support.

Behavioral: WhatsApp-based education group

Interventions

Participants in the intervention group will receive the same routine face-to-face diabetes education and insulin injection training as the control group, plus a structured WhatsApp-based educational program. The WhatsApp intervention will be delivered over four weeks and include booklets/brochures, photos, and videos on diabetes definition and symptoms, complications, recognition and management of hypoglycemia and hyperglycemia, foot care, nutrition, exercise, oral antidiabetic and insulin therapy, and insulin injection demonstration. Participants' questions will be answered through WhatsApp to provide interactive support.

WhatsApp-based education group

Participants in the control group will receive routine face-to-face diabetes education and insulin injection training provided during hospitalization. The education is delivered verbally to patients and their caregivers by the clinical staff. After the follow-up period and data collection are completed, participants in the control group will also be offered access to the WhatsApp-based educational materials used in the intervention group.

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years and older
  • Diagnosis of ischemic stroke
  • Mini-Mental Test (MMT) score \> 18
  • Receiving insulin therapy for type 2 diabetes mellitus (T2DM)
  • Ability to use WhatsApp on a smartphone (participant or caregiver)
  • Willingness to provide informed consent

You may not qualify if:

  • Presence of major organ failure
  • Development of severe T2DM-related complications (e.g., diabetic foot, nephropathy, cardiovascular disease)
  • Cognitive or communication impairments preventing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Stroke

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

nilgün aras, Ph.D.

CONTACT

Büşra Nur Yüksek, MSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 6, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

October 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share