- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940350
Telerehabilitation-Based Coaching Interventions (TeleSCoP) for Patients With Ischemic Stroke
The Effect of Telerehabilitation-Based Coaching Interventions (TeleSCoP) on Self-Efficacy, Modifiable Risk Factors, and Repeated Hospitalizations in Patients With Ischemic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kamile Topcu, MSc
- Phone Number: +905418651989
- Email: kamile-m@hotmail.com
Study Contact Backup
- Name: Hicran Bektas, PhD, RN
- Email: hbaydin@akdeniz.edu.tr
Study Locations
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-
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Antalya, Turkey (Türkiye), 07060
- Recruiting
- Akdeniz University Hospital
-
Contact:
- Hicran Bektas, PhD, RN
- Email: hbaydin@akdeniz.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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 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.
|
|
No Intervention: Control group
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Stroke Self-Efficacy Questionnaire
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic Parameter Evaluation Form
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unplanned Hospital Applications Follow-up Form
Time Frame: 12 weeks
|
As a result of the telerehabilitation-based coaching intervention of the patients in the intervention group, it is predicted that the number of repeated hospitalizations and unplanned hospital admissions will decrease.
For this purpose, an Unplanned Hospital Application Form was prepared by the researchers to evaluate unplanned hospital admissions.
With this form, unplanned hospital or emergency service admission, unplanned hospitalization, unplanned outpatient admission, and unplanned need for a new medication in the last three months of ischemic stroke patients in the intervention group will be evaluated.
In addition, the patient's applications to the health institution within the last three months will be evaluated by the researcher through the hospital automation system.
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12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hicran Bektas, PhD, RN, Akdeniz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1234 (Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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