Clinical trial NCT05940350: Telerehabilitation-Based Coaching Interventions (TeleSCoP) for Patients With Ischemic Stroke
Official title: The Effect of Telerehabilitation-Based Coaching Interventions (TeleSCoP) on Self-Efficacy, Modifiable Risk Factors, and Repeated Hospitalizations in Patients With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Coaching
Keywords: Coaching Interventions
Ischemic Stroke
Nursing
Randomized Controlled Trial
Modifiable Risk Factors
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Stroke Self-Efficacy Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: Metabolic Parameter Evaluation Form
timeFrame: 12 weeks
Other outcomes:
measure: Unplanned Hospital Applications Follow-up Form
timeFrame: 12 weeks
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Hicran Bektas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: