Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05940350 |
| Other study ID # |
1234 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Akdeniz University |
| Contact |
Kamile Topcu, MSc |
| Phone |
+905418651989 |
| Email |
kamile-m[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
