Stroke ( 3 Months After Onset)NCT07181629
Dysphagia Management for Caregivers of Stroke Patients
A study testing Dysphagia Management Education in people with Stroke ( 3 Months After Onset) and Dysphagia, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke ( 3 Months After Onset), Dysphagia, Palliative Care
- What is being tested?
- Dysphagia Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 higher. The patient is receiving parenteral nutrition. The patient is receiving immunosuppressive therapy/immunotherapy and/or chemotherapy.
- The patient has been diagnosed with cancer, an endocrine system disease, or a gastrointestinal disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Simav Assoc. Prof. Dr. İsmail Karakuyu State Hospital Home Health Services Unit
Kütahya
About this study
Official title: Effectiveness of a Dysphagia Management Education Program for Caregivers of Stroke Patients Receiving Home Care
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.
Read the detailed description
The experimental randomized controlled trial 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). Patients who met the inclusion criteria were assigned to the experimental (n=42) and control (n=42) groups using a simple randomization technique. Data were collected using the 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.In data evaluation, percentages, means, independent t-tests, Pearson chi-square tests, Yates chi-square tests, repeated measures variance analysis (ANOVA), Pearson correlation tests, and Bonferroni tests were used.
- Conditions
- Stroke ( 3 Months After Onset), Dysphagia, Palliative Care, Caregiver
- Being tested
- Control, Dysphagia Management Education
- Keywords
- Stroke, difficulty swallowing, caregiver, malnutrition, quality of life, caregiver burden
- Medical subject headings
- Stroke, Deglutition Disorders, Malnutrition, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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 administered to caregivers of stroke patients at each interview (at 0, 1, and 3 months).
Dysphagia Management EducationBehavioural
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 administered to caregivers of stroke patients at each interview (at 0, 1, and 3 months). The intervention group received dysphagia management training after the questionnaires were administered at the first meeting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dysphagia Management Education Receives: Behavioral: Dysphagia Management Education |
| Control | Other | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care burden level
The Zarit Care Burden Scale consists of 22 statements. As the score increases, the care burden also increases, and the maximum score is 88. Scores are graded as follows: (0-20) little/no burden, (21-40) moderate burden, (41-60) severe burden, and (61-88) excessive burden.
Measured: 0th month (1st day), 1st month and 3rd month
Quality of Life level
SF-36 Quality of Life Scale: The scale consists of 36 questions and eight subscales. Each subscale is scored separately from 0 to 100. Higher scores indicate better health.
Measured: 0th month (1st day), 1st month and 3rd month
Nutritional Assessment level
The MNA form consists of six questions. The maximum total score is 14. Individuals with a score of 12 or higher are considered to have adequate nutritional status, those with a score between 8 and 11 are at risk for malnutrition, and those with a score of 7 or less are considered malnourished.
Measured: 0th month (1st day), 1st month and 3rd month
Dysphagia management knowledge level
The Dysphagia Management Knowledge Form for Stroke Patients Form for Stroke Patients consists of 26 statements, each answered with a true (0 point) or false (1 point) score. Scale scores range from 0 to 26. Higher scores indicate higher knowledge levels.
Measured: 0th month (1st day), 1st month and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Dec 2021
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke ( 3 Months After Onset)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hicran Yıldız, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181629
- Sponsor's protocol ID
- H.Yıldız1
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Dysphagia Management Education Program for Caregivers of Stroke Patients Receiving Home Care
- ClinicalTrials.gov ID
- NCT07181629
- Acronym / sponsor ID
- H.Yıldız1
- Conditions
- Stroke ( 3 Months After Onset), Dysphagia, Palliative Care, Caregiver
- Keywords
- Stroke, difficulty swallowing, caregiver, malnutrition, quality of life, caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The experimental randomized controlled trial 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). Patients who met the inclusion criteria were assigned to the experimental (n=42) and control (n=42) groups using a simple randomization technique. Data were collected using the 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.In data evaluation, percentages, means, independent t-tests, Pearson chi-square tests, Yates chi-square tests, repeated measures variance analysis (ANOVA), Pearson correlation tests, and Bonferroni tests were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dysphagia Management EducationDysphagia Management Education |
| Control | Other | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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.
- The patient has a Barthel index score of 91 or higher. The patient is receiving parenteral nutrition. The patient is receiving immunosuppressive therapy/immunotherapy and/or chemotherapy.
- The patient has been diagnosed with cancer, an endocrine system disease, or a gastrointestinal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThe 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 administered to caregivers of stroke patients at each interview (at 0, 1, and 3 months). | Other | Control |
| Dysphagia Management EducationThe 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 administered to caregivers of stroke patients at each interview (at 0, 1, and 3 months). The intervention group received dysphagia management training after the questionnaires were administered at the first meeting. | Behavioural | Intervention |
Primary outcome
Care burden level
Time frame: 0th month (1st day), 1st month and 3rd month
The Zarit Care Burden Scale consists of 22 statements. As the score increases, the care burden also increases, and the maximum score is 88. Scores are graded as follows: (0-20) little/no burden, (21-40) moderate burden, (41-60) severe burden, and (61-88) excessive burden.
Quality of Life level
Time frame: 0th month (1st day), 1st month and 3rd month
SF-36 Quality of Life Scale: The scale consists of 36 questions and eight subscales. Each subscale is scored separately from 0 to 100. Higher scores indicate better health.
Nutritional Assessment level
Time frame: 0th month (1st day), 1st month and 3rd month
The MNA form consists of six questions. The maximum total score is 14. Individuals with a score of 12 or higher are considered to have adequate nutritional status, those with a score between 8 and 11 are at risk for malnutrition, and those with a score of 7 or less are considered malnourished.
Dysphagia management knowledge level
Time frame: 0th month (1st day), 1st month and 3rd month
The Dysphagia Management Knowledge Form for Stroke Patients Form for Stroke Patients consists of 26 statements, each answered with a true (0 point) or false (1 point) score. Scale scores range from 0 to 26. Higher scores indicate higher knowledge levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dysphagia Management Education in people with Stroke ( 3 Months After Onset) and Dysphagia, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care burden level (time frame: 0th month (1st day), 1st month and 3rd month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.