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Ischemic StrokeNCT05940350

Telerehabilitation-Based Coaching Interventions (TeleSCoP) for Patients With Ischemic Stroke

A study testing Telerehabilitation Stroke Coaching of Program (TeleSCoP) group in people with Ischemic Stroke and Coaching, run by Akdeniz University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Ischemic stroke has high morbidity and mortality worldwide. Stroke patients experience physical, psychological, and social problems, and require rehabilitation. The aim of stroke rehabilitation is to support patients in optimizing their physical, functional, mental, social, and occupational aspects. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Ischemic Stroke, Coaching
What is being tested?
Telerehabilitation Stroke Coaching of Program (TeleSCoP) group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2025to 1 Mar 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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients aged 45 years and older who had a stroke (the etiology of ischemic stroke can be seen at an earlier age due to hematological conditions, such as sickle cell anemia, polycythemia vera, factor deficiencies, vasculitis, and arterial dissection).
  • Comply with TOAST classification criteria
  • A score of "0,1,2,3" according to the Modified Rankin Scale at discharge
  • Place, time, person orientation
  • No communication barrier
  • Turkish-speaking writer
Show all 9Show fewer
  • Having a contact phone (for phone calls)
  • Support can be obtained from first-degree situations)
  • Having no barriers to answering questions physically and mentally

Who cannot join

  • Stroke of cryptogenic (etiology unknown) or non-vascular origin (tumor)
  • Have a diagnosed mental or psychiatric illness*
  • With dementia and cognitive deficit*
  • Clinically musculoskeletal or other neurological diseases*
  • With severe aphasia and dysarthria*
  • With terminal illness*
  • Those who score ≥ 10 according to the LACE index
  • Patients whose information cannot be accessed will not be included in the study.

Trial locations and contacts

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

Kamile Topcu, MSc contact

+905418651989

kamile-m@hotmail.com

Hicran Bektas, PhD, RN contact

hbaydin@akdeniz.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Akdeniz University Hospital

    Antalya, 07060

    Hicran Bektas, PhD, RN, hbaydin@akdeniz.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Telerehabilitation-Based Coaching Interventions (TeleSCoP) on Self-Efficacy, Modifiable Risk Factors, and Repeated Hospitalizations in Patients With Ischemic Stroke

Ischemic stroke has high morbidity and mortality worldwide. Stroke patients experience physical, psychological, and social problems, and require rehabilitation. The aim of stroke rehabilitation is to support patients in optimizing their physical, functional, mental, social, and occupational aspects. Telerehabilitation-based coaching interventions are among the individualized interventions applied to patients. This study aimed to examine the effects of telerehabilitation-based coaching interventions on self-efficacy, modifiable risk factors, and repeated hospitalizations in patients with ischemic stroke. It is predicted that discharge education in disease management and telerehabilitation-based coaching interventions will increase self-efficacy, reduce modifiable risk factors (blood pressure, cholesterol, triglyceride, HbA1c levels, body mass index, smoking, and alcohol use), and reduce repeated hospitalizations. With an education booklet prepared for ischemic stroke patients and primary care providers, one-on-one face-to-face education is planned while patients are in the clinic on the fourth or fifth day of stroke. Determination of individual goals with motivational interview, sending educational videos prepared in cooperation with the multidisciplinary health team to the phones or e-mails of the patients, providing telerehabilitation-based coaching a total of seven times for three months after discharge, monitoring the targets set weekly and monthly, and monthly follow-up after three months. It is planned to support patients with practices such as achieving their goals, maintaining healthy lifestyle changes such as diet and physical activity, and monitoring metabolic parameters. The evaluation form of the education booklet, videos prepared with the cooperation of the multidisciplinary team, and phone call evaluation form will be evaluated by 10 experts. The preliminary application will be tested with 6 patients, and the final form will be provided. The second phase of the study was designed as a single-center, single-blind (participant), randomized controlled study. The study will be carried out with a total of 60 patients with ischemic stroke, 30 in the intervention group and 30 in the control group, who continued to be followed up and treated at the Neurology Clinic of Akdeniz University Hospital.

Read the detailed description

Ischemic stroke has high morbidity and mortality worldwide. Stroke patients experience physical, psychological, and social problems, and require rehabilitation. The aim of stroke rehabilitation is to support patients in optimizing their physical, functional, mental, social, and occupational aspects. Telerehabilitation-based coaching interventions are among the individualized interventions applied to patients. This study aimed to examine the effects of telerehabilitation-based coaching interventions on self-efficacy, modifiable risk factors, and repeated hospitalizations in patients with ischemic stroke. It is predicted that discharge education in disease management and telerehabilitation-based coaching interventions will increase self-efficacy, reduce modifiable risk factors (blood pressure, cholesterol, triglyceride, HbA1c levels, body mass index, smoking, and alcohol use), and reduce repeated hospitalizations. With an education booklet prepared for ischemic stroke patients and primary care providers, one-on-one face-to-face education is planned while patients are in the clinic on the fourth or fifth day of stroke. Determination of individual goals with motivational interview, sending educational videos prepared in cooperation with the multidisciplinary health team to the phones or e-mails of the patients, providing telerehabilitation-based coaching a total of seven times for three months after discharge, monitoring the targets set weekly and monthly, and monthly follow-up after three months. It is planned to support patients with practices such as achieving their goals, maintaining healthy lifestyle changes such as diet and physical activity, and monitoring metabolic parameters. The evaluation form of the education booklet, videos prepared with the cooperation of the multidisciplinary team, and phone call evaluation form will be evaluated by 10 experts. The preliminary application will be tested with 6 patients, and the final form will be provided. The second phase of the study was designed as a single-center, single-blind (participant), randomized controlled study. The study will be carried out with a total of 60 patients with ischemic stroke, 30 in the intervention group and 30 in the control group, who continued to be followed up and treated at the Neurology Clinic of Akdeniz University Hospital.

It is predicted that discharge education in disease management and telerehabilitation-based coaching interventions will increase self-efficacy, reduce modifiable risk factors (blood pressure, cholesterol, triglyceride, HbA1c levels, body mass index, smoking, and alcohol use), and reduce repeated hospitalizations.

The research consisted of two stages. The aim was to develop telerehabilitation-based coaching interventions (TeleSCoP) in patients with ischemic stroke in the first stage and to test the effect of second-stage telerehabilitation-based coaching interventions in a randomized controlled study. To improve the self-efficacy of stroke patients, reduce their modifiable risk factors, and prevent repeated hospitalizations, a education booklet will be created, informative videos will be prepared in cooperation with a multidisciplinary team for stroke rehabilitation, and telelerehabilitation-based coaching initiatives will be implemented by making phone follow-ups. Within the scope of stroke management, a education booklet will be prepared in line with current literature, national and international websites, and guidelines. The content of the education booklet is evaluated based on expert opinions and the readability index, and the final shape is determined by testing it with a preliminary application. The second phase of the study was designed as a single-center, single-blind (participant), randomized controlled trial. The study will be carried out with a total of 60 patients with ischemic stroke, 30 in the intervention group and 30 in the control group, who were followed up and treated at the Neurology Clinic of Akdeniz University Hospital, and who met the criteria for inclusion in the sampling. A three-month telerehabilitation-based coaching intervention will be applied to stroke patients in the intervention group. Within the scope of telerehabilitation-based coaching initiatives, coaching initiatives will be planned for the management of the symptoms and complications of modifiable risk factors. The patients in the intervention group will receive discharge education with the education booklet prepared on the 4th or 5th day in the hospital, and informative videos prepared in cooperation with the multidisciplinary team will be shared with the patients. The patients will be called by phone at weeks 1, 2, 3, 4, 6, 8, and 10. The patients in the control group will be given the "Stroke Education Brochure" of the Ministry of Health and will benefit from routine hospital services for three months. Outcome measures in the study will be evaluated using the Personal Information Form, Stroke Self-Efficacy Scale, Modifiable Risk Factors Follow-up Form, Stroke Self-Efficacy Scale, Modifiable Risk Factors Follow-up Form, and Unplanned Hospital Admissions Follow-up Form when the patients are included in the study at the beginning. Research data will be collected by a statistician who does not know which group the patients are in, using descriptive statistics, t-test, One-Way ANOVA, correlation, Cronbach's alpha coefficient, and intention-to-treat analysis in the SPSS 24.0 program.

Being tested
Telerehabilitation Stroke Coaching of Program (TeleSCoP) group
Keywords
Coaching Interventions, Ischemic Stroke, Nursing, Randomized Controlled Trial, Modifiable Risk Factors
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Telerehabilitation Stroke Coaching of Program (TeleSCoP) groupBehavioural

    The sampling criteria will be assigned to the intervention (TeleSCoP) and control groups by stratified randomization (1:1) in patients with acute ischemic stroke. A three-month telerehabilitation-based coaching intervention will be applied to stroke patients in the intervention group. Within the scope of telerehabilitation-based coaching initiative, coaching initiatives will be planned for the management of symptoms and complications for modifiable risk factors. Patients in the intervention group will receive discharge education with the education booklet prepared on the 4th or 5th day in the hospital, and informative videos prepared in cooperation with the multidisciplinary team will be shared with the patients. Patients will be called by phone at weeks 1, 2, 3, 4, 6, 8, and 10. The patients in the control group will be given the "Stroke Education Brochure" of the Ministry of Health and they will benefit from routine hospital services for three months.

Study groups in NCT05940350
Study groupRoleWhat they receive
Intervention groupExperimentalA three-month telerehabilitation-based coaching intervention will be applied to stroke patients in the intervention group. Within the scope of telerehabilitation-based coaching initiative, coaching initiatives will be planned for the management of symptoms and complications for modifiable risk factors. Patients in the intervention group will receive discharge education with the education booklet prepared on the 4th or 5th day in the hospital, and informative videos prepared in cooperation with the multidisciplinary team will be shared with the patients. Patients will be called by phone at weeks 1, 2, 3, 4, 6, 8, and 10.
Receives: Behavioral: Telerehabilitation Stroke Coaching of Program (TeleSCoP) group
Control groupNo interventionThe patients in the control group will be given the "Stroke Education Brochure" of the Ministry of Health and they will benefit from routine hospital services for three months

What is being measured

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

  1. The Stroke Self-Efficacy Questionnaire

    The Stroke Self-Efficacy Questionnaire (SSEQ) will be used to determine the self-efficacy levels of patients with ischemic stroke. It is a form used to determine the self-efficacy levels of patients during the recovery period after stroke. The scale consists of 13 items, and the daily activities and self-management levels of patients with stroke are evaluated. Turkish validity and reliability of the scale were established and the Cronbach's alpha value was found to be 0.93.

    Measured: 12 weeks

Secondary outcomes (1)
  1. Metabolic Parameter Evaluation Form

    Modifiable Risk Factors Follow-up Form was prepared by the researchers to determine modifiable risk factors in patients with ischemic stroke. This form includes information such as blood pressure (mmHg), metabolic parameters (HDL [mg\dL] LDL [mg\dL], total cholesterol [mg\dL], triglyceride [mg\dL], HbA1c [mmol/lt], INR [seconds], APTT [seconds], PT [seconds]), weight (kilograms), height (meters), body mass index (kg/m2) [weight and height will be combined to report BMI in kg/m2], smoking (number of cigarettes/day) and alcohol (number of glasses/day)use.

    Measured: 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 posted11 Jul 2023
  2. Study start1 Feb 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Mar 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
Model description
The sampling criteria will be assigned to the intervention (TeleSCoP) and control groups by stratified randomization (1:1) in patients with acute ischemic stroke. A three-month telerehabilitation-based coaching intervention will be applied to stroke patients in the intervention group. Within the scope of telerehabilitation-based coaching initiative, coaching initiatives will be planned for the management of symptoms and complications for modifiable risk factors. Patients in the intervention group will receive discharge education with the education booklet prepared on the 4th or 5th day in the hospital, and informative videos prepared in cooperation with the multidisciplinary team will be shared with the patients. Patients will be called by phone at weeks 1, 2, 3, 4, 6, 8, and 10. The patients in the control group will be given the "Stroke Education Brochure" of the Ministry of Health and they will benefit from routine hospital services for three months.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940350
Sponsor's protocol ID
1234
Status last verified
Dec 2025
First submitted
5 Jun 2023
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
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 Telerehabilitation Stroke Coaching of Program (TeleSCoP) group in people with Ischemic Stroke and Coaching, run by Akdeniz 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?

The sponsor lists 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Dec 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 Kamile Topcu, MSc (+905418651989, kamile-m@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Stroke Self-Efficacy Questionnaire (time frame: 12 weeks). 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 18 Dec 2025.

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