Dysphagia Management for Caregivers of Stroke Patients (NCT07181629) | Clinical Trial Compass
CompletedNot Applicable
Dysphagia Management for Caregivers of Stroke Patients
Turkey (Türkiye)84 participantsStarted 2021-12-15
Plain-language summary
This randomized controlled experimental study was conducted to evaluate the effects of dysphagia management training provided to caregivers of stroke patients receiving home care. The sample size was determined using power analysis (n=84). Data were collected using the Personal Information Form, Mini Nutritional Assessment-Short Form (MNA-SF), Zarit Caregiver Burden Scale, Short Form-36 (SF-36) Quality of Life Questionnaire, and the Dysphagia Management Knowledge Form for Stroke Patients. Questionnaires were administered to both groups at baseline, the 1st month, and the 3rd month. The first application was administered to the intervention group before the education session.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Caregivers:
The caregiver must be between 18 and 60 years old. The caregiver must be willing and able to participate in the study. The caregiver must have at least a primary school education. The caregiver must be primarily responsible for the patient's care. The caregiver's Mini Mental Test score must be 25 or more. The caregiver's Beck Depression Inventory score must be below 17. The caregiver's Caregiver's Readiness to Care Scale score must be 16 or more.
Patients:
The patient's National Institutes of Health (NIH) Stroke Scale score must be 20 or less.
The patient must be between 18 and 60 years old. The patient must be receiving home care services. The patient must have been diagnosed with a stroke at least six months ago. The patient must have a Barthel index score of 90 or below.
Exclusion Criteria:
Caregivers:
The caregiver has a physical disability or serious health problem that makes caregiving difficult.
The caregiver has a Mini Mental Test score below 25 points. The caregiver has a Beck Depression Inventory score of 17 or higher. The caregiver has a Caregiver Readiness Scale score of 16 or lower. The caregiver has communication difficulties. The caregiver has a depression or psychiatric diagnosis. The caregiver is receiving psychotherapy/psychological support. The caregiver is taking antidepressants and/or anxiolytics. The caregiver has sensory loss related to vision or hearing.
Patients:
The patient has a Barthel index score of 91 or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Care burden level
Timeframe: 0th month (1st day), 1st month and 3rd month
2
Quality of Life level
Timeframe: 0th month (1st day), 1st month and 3rd month
3
Nutritional Assessment level
Timeframe: 0th month (1st day), 1st month and 3rd month
4
Dysphagia management knowledge level
Timeframe: 0th month (1st day), 1st month and 3rd month