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

NCT05940350 | Recruiting DMC

• 1 other identifier: 1234
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke; Coaching

Keywords

Coaching Interventions; Ischemic Stroke; Nursing; Randomized Controlled Trial; Modifiable Risk Factors

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (1)

• Metabolic Parameter Evaluation Form

  12 weeks

Other Outcomes (1)

• Unplanned Hospital Applications Follow-up Form

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Telerehabilitation Stroke Coaching of Program (TeleSCoP) group

Control group

NO INTERVENTION

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

Interventions

Telerehabilitation Stroke Coaching of Program (TeleSCoP) group BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Having a contact phone (for phone calls)
• Support can be obtained from first-degree situations)
• Having no barriers to answering questions physically and mentally

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07060, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Hicran Bektas, PhD, RN

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamile Topcu, MSc

CONTACT

+905418651989; kamile-m@hotmail.com

Hicran Bektas, PhD, RN

CONTACT

hbaydin@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be divided into groups according to the randomization list created to assign each patient to a group. Two independent researchers will conduct the assigned participants to the intervention and control groups and the evaluated the outcome measurement data. Researchers will not be blinded because they will perform these interventions. However, the participants will be blinded because they do not know which group they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Akdeniz University Hospital

Model Details: 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 Record Dates

• First Submitted: June 5, 2023
• First Posted: July 11, 2023
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)