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Type 2 Diabetes Mellitus (T2DM)WEPS-PNCT07207694

WhatsApp-Based Education Program for Stroke Patients

A study testing WhatsApp-based education group and Active Comparator: Routine Education in people with Type 2 Diabetes Mellitus (T2DM) and Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM), Stroke
What is being tested?
WhatsApp-based education group and Active Comparator: Routine Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
No sites listed yet
Study dates
15 Oct 2025to 15 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

nilgün aras, Ph.D. contact

+90 5054521883

nilgunozsoy@yahoo.com

Büşra Nur Yüksek, MSN contact

+903121416

About this study

Official title: The Effect of WhatsApp-Supported Education and Counseling on Healthy Lifestyle Behaviors, Glycemic Control, and Knowledge Levels in Patients With Stroke

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.

Read more

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.

Read the detailed description

Stroke remains the second leading cause of mortality and long-term disability worldwide. Type 2 diabetes mellitus (T2DM) is a well-established risk factor, doubling the risk of ischemic stroke compared with non-diabetic individuals. Glycemic dysregulation occurs in approximately two-thirds of patients after acute stroke and is directly correlated with both the severity of the acute cerebrovascular event and the likelihood of recurrence. Persistent poor glycemic control following stroke further increases the risk of recurrent events and reflects poor adherence to treatment regimens. Therefore, interventions that enhance glycemic control and promote adherence are of paramount importance in the secondary prevention of stroke among T2DM patients.

Educational and counseling interventions play a central role in diabetes self-management. Timely and appropriate insulin administration is essential for maintaining blood glucose levels within target ranges. Previous studies have demonstrated that structured diabetes and insulin education improves patients' glycemic outcomes and treatment adherence. In recent years, mobile health technologies and digital platforms have been increasingly used to support self-management and education. WhatsApp, a widely available and user-friendly communication platform, has proven effective in improving diabetes knowledge, self-efficacy, and self-management behaviors in individuals with T2DM. Nevertheless, there is a paucity of research evaluating the use of WhatsApp-based education and counseling specifically in stroke patients with coexisting T2DM, despite their high vulnerability to complications and recurrent stroke.

This randomized controlled trial was designed to address this gap by investigating the effectiveness of WhatsApp-supported education and counseling in improving healthy lifestyle behaviors, glycemic control, and knowledge levels among stroke patients undergoing insulin therapy. The study will be conducted at SBÜ Gaziler Physical Training and Rehabilitation Research Hospital.

Eligible participants will be adults aged 18 years and older with a diagnosis of ischemic stroke and T2DM, a Mini-Mental Test score greater than 18, and who are receiving insulin therapy. Exclusion criteria include incomplete data collection, major organ failure, or severe T2DM-related complications (e.g., diabetic foot, nephropathy, cardiovascular disease). Based on power analysis using a prior study on diabetes knowledge improvement, a total of 84 participants (42 in each group) will be recruited. Randomization will be performed in a 1:1 ratio using block randomization with four-unit blocks and six possible combinations, conducted independently via an online randomization tool (randomizer.org).

The control group will receive routine face-to-face diabetes education and insulin injection training delivered verbally during hospitalization. The intervention group will receive the same routine education plus a structured four-week WhatsApp-based education program. The WhatsApp intervention will deliver weekly educational content, including booklets, photos, and videos, covering the following topics:

Week 1: Definition, types, and symptoms of T2DM

Week 2: Complications of T2DM; recognition and management of hypoglycemia and hyperglycemia; importance of foot care

Week 3: Nutrition and exercise in diabetes management

Week 4: Diabetes treatment, including oral antidiabetic agents, insulin therapy, and insulin injection demonstration

In addition, participants in the intervention group will be able to ask questions through WhatsApp, which will be answered by the research team to ensure interactive and continuous support.

Data will be collected at baseline (T0) and six months after the intervention (T1). Tools include the Revised Diabetes Knowledge Test-2 (23 items), the Healthy Lifestyle Behavior Scale (34 items, 5-point Likert), and a demographic/clinical data form including sociodemographic characteristics, comorbidities, medications, fasting glucose, fasting insulin, HbA1c, and HOMA-IR levels. The Revised Diabetes Knowledge Test-2 has been validated in Turkish, and the Healthy Lifestyle Behavior Scale has demonstrated high reliability (Cronbach's alpha = 0.86).

All assessments will be conducted by a trained nurse in the stroke clinic. Data analysis will use SPSS software, applying descriptive statistics, normality tests, and appropriate parametric or non-parametric tests. Reliability will be assessed using Cronbach's alpha. A p-value of <0.05 will be considered statistically significant.

Ethical approval has been granted by the Ethics Committee of SBÜ Gaziler Physical Training and Rehabilitation Research Hospital (Approval No: E-34215015). Written informed consent will be obtained from all participants prior to enrollment.

The study is expected to demonstrate that WhatsApp-supported education and counseling, when integrated with routine hospital-based education, enhance patient knowledge, foster healthier lifestyle behaviors, and improve glycemic control in stroke patients with T2DM. If proven effective, this intervention may provide an accessible, cost-effective, and scalable approach for integrating mobile health tools into rehabilitation nursing and chronic disease management programs, ultimately contributing to better long-term outcomes and reduced recurrence of stroke.

Being tested
WhatsApp-based education group, Active Comparator: Routine Education
Keywords
Healthy Lifestyle Behaviors, type 2 diabetes mellitus, stroke
Medical subject headings
Diabetes Mellitus, Type 2, Stroke

What participants receive

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

  • WhatsApp-based education groupBehavioural

    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.

  • Active Comparator: Routine EducationBehavioural

    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.

Study groups in NCT07207694
Study groupRoleWhat they receive
control groupActive comparatorParticipants 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.
Receives: Behavioral: Active Comparator: Routine Education
WhatsApp-based education groupExperimentalParticipants 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.
Receives: Behavioral: WhatsApp-based education group

What is being measured

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

  1. 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.

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

  2. Change in HbA1c

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

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

  3. 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

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Timeline

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

  1. First posted6 Oct 2025
  2. Study start15 Oct 2025 (estimated)
  3. Primary completion15 Aug 2026 (estimated)
  4. Study completion15 Nov 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07207694
Sponsor's protocol ID
E-34215015-771
Other IDs
E-34215015
Acronym
WEPS-P
Status last verified
Aug 2025
First submitted
25 Sep 2025
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing WhatsApp-based education group and Active Comparator: Routine Education in people with Type 2 Diabetes Mellitus (T2DM) and Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

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 nilgün aras, Ph.D. (+90 5054521883, nilgunozsoy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Diabetes Knowledge (time frame: Baseline (T0) and 6 months after intervention (T1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Oct 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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