Stroke Patients and Their CaregiversNCT07640412
MPACT OF A HOME CARE GUIDE FOR DAILY LIVING ACTIVITIES ON STROKE CAREGIVERS' BURDEN AND EXPERIENCE
A study testing Training and Materials in people with Stroke Patients and Their Caregivers, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to develop a home care guide, led by nurses, for stroke patients to maintain their activities of daily living, based on evidence-based current literature and guidelines, and to test the effect of this guide on caregiver burden. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Patients and Their Caregivers
- What is being tested?
- Training and Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals who have a patient diagnosed with stroke at least 6 months ago,
- Those who are in the position of providing continuous care,
- Those whose care recipients have a score below 60 on the Barthel Activities of Daily Living Index,
- Individuals who volunteer to participate in the study will be included in the study.
Who cannot join
- Individuals who have participated in a similar study in which training on home care for stroke patients was provided,
- Those who have physical, cognitive, or memory-related problems,
- Those whose care recipients have a score of 60 or above on the Barthel Activities of Daily Living Index,
- Individuals who do not agree to participate in the study will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF A HOME CARE GUIDE DEVELOPED FOR ACTIVITIES OF DAILY LIVING ON THE CAREGIVER BURDEN AND EXPERIENCES OF STROKE PATIENT CAREGIVERS
The study aims to develop a home care guide, led by nurses, for stroke patients to maintain their activities of daily living, based on evidence-based current literature and guidelines, and to test the effect of this guide on caregiver burden. The results expected from this study are anticipated to contribute to the continuity of care in stroke patients, enhance self-care abilities through participation in daily activities, ensure adherence to treatment and care, control symptoms, reduce repeated hospitalizations, and improve the quality of life of caregivers by alleviating their caregiver burden.
The study was conducted in the home environment with caregivers of stroke patients registered at the Home Health Services unit of Sivas Numune Hospital.
- Conditions
- Stroke Patients and Their Caregivers
- Being tested
- Training and Materials
- Keywords
- Activities of Daily Living, Home Care Guide, Caregiver Burden, Stroke Patients, Caregiver Experiences
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and MaterialsOther
The home care guide developed for activities of daily living was provided to the intervention group, and training related to it was delivered.
| Study group | Role | What they receive |
|---|---|---|
| HOME CARE GUIDE | Active comparator | The intervention group received training along with the developed home care guide, and pre-test, mid-test, and post-test were administered. Receives: Other: Training and Materials |
| Control Group | No intervention | In the control group, pre-test and post-test were administered without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form for Caregivers
It includes items such as the caregiver's demographic data (age, gender, marital status, number of children, education level, occupation, degree of relationship to the patient, income status), patient care experience, the presence of chronic diseases accompanying the stroke diagnosis, and the duration of caregiving.
Measured: This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
Caregiver Burden Scale
The scale consists of 22 items that determine the impact of caregiving on the lives of individuals who care for a person in need. The scale is a Likert-type instrument ranging from 0 to 4, with the options 'never,' 'rarely,' 'sometimes,' 'quite frequently,' and 'almost always.' The minimum score that can be obtained from the scale is 0 and the maximum score is 88. The items in the scale generally focus on social and emotional aspects, and a higher total score indicates a higher level of distress experienced by the caregiver. The scores are evaluated as follows: 0-20 indicates little or no burden, 21-40 indicates mild to moderate burden, 41-60 indicates moderate to severe burden, and 61-88 indicates severe burden. The Cronbach's alpha reliability coefficient of the scale is 0.95.
Measured: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
Bakas Caregiving Outcomes Scale
The scale consists of 16 items and evaluates the positive and negative life changes experienced as a result of caregiving, ranging from the best direction (+3) to the worst direction (-3) (min. 15, max. 105). The scale has no subdimensions. As the total score obtained from the scale increases, it indicates a 'positive change,' while a decrease in the score indicates a 'negative change.' The Turkish validity and reliability study of the scale was conducted by Can and Cavlak in 2010. In that study, the internal consistency coefficient of the scale was found to be 0.90, and the test-retest reliability was 0.961.
Measured: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 May 2025
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Patients and Their CaregiversStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MESUT DİREK, Cumhuriyet University
- Investigators
- MUKADDER MOLLAOĞLU, Prof.Dr., Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640412
- Sponsor's protocol ID
- 2024-12/43
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A HOME CARE GUIDE DEVELOPED FOR ACTIVITIES OF DAILY LIVING ON THE CAREGIVER BURDEN AND EXPERIENCES OF STROKE PATIENT CAREGIVERS
- ClinicalTrials.gov ID
- NCT07640412
- Acronym / sponsor ID
- 2024-12/43
- Conditions
- Stroke Patients and Their Caregivers
- Keywords
- Activities of Daily Living, Home Care Guide, Caregiver Burden, Stroke Patients, Caregiver Experiences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 Jun 2026 (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.
The study aims to develop a home care guide, led by nurses, for stroke patients to maintain their activities of daily living, based on evidence-based current literature and guidelines, and to test the effect of this guide on caregiver burden. The results expected from this study are anticipated to contribute to the continuity of care in stroke patients, enhance self-care abilities through participation in daily activities, ensure adherence to treatment and care, control symptoms, reduce repeated hospitalizations, and improve the quality of life of caregivers by alleviating their caregiver burden.
The study was conducted in the home environment with caregivers of stroke patients registered at the Home Health Services unit of Sivas Numune Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOME CARE GUIDE | Active comparator | Other: Training and MaterialsThe intervention group received training along with the developed home care guide, and pre-test, mid-test, and post-test were administered. |
| Control Group | No intervention | –In the control group, pre-test and post-test were administered without any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who have a patient diagnosed with stroke at least 6 months ago,
- Those who are in the position of providing continuous care,
- Those whose care recipients have a score below 60 on the Barthel Activities of Daily Living Index,
- Individuals who volunteer to participate in the study will be included in the study.
Key exclusion criteria (4 listed)
- Individuals who have participated in a similar study in which training on home care for stroke patients was provided,
- Those who have physical, cognitive, or memory-related problems,
- Those whose care recipients have a score of 60 or above on the Barthel Activities of Daily Living Index,
- Individuals who do not agree to participate in the study will not be included in the study.
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 |
|---|---|---|
| Training and MaterialsThe home care guide developed for activities of daily living was provided to the intervention group, and training related to it was delivered. | Other | HOME CARE GUIDE |
Primary outcome
Personal Information Form for Caregivers
Time frame: This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
It includes items such as the caregiver's demographic data (age, gender, marital status, number of children, education level, occupation, degree of relationship to the patient, income status), patient care experience, the presence of chronic diseases accompanying the stroke diagnosis, and the duration of caregiving.
Caregiver Burden Scale
Time frame: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
The scale consists of 22 items that determine the impact of caregiving on the lives of individuals who care for a person in need. The scale is a Likert-type instrument ranging from 0 to 4, with the options 'never,' 'rarely,' 'sometimes,' 'quite frequently,' and 'almost always.' The minimum score that can be obtained from the scale is 0 and the maximum score is 88. The items in the scale generally focus on social and emotional aspects, and a higher total score indicates a higher level of distress experienced by the caregiver. The scores are evaluated as follows: 0-20 indicates little or no burden, 21-40 indicates mild to moderate burden, 41-60 indicates moderate to severe burden, and 61-88 indicates severe burden. The Cronbach's alpha reliability coefficient of the scale is 0.95.
Bakas Caregiving Outcomes Scale
Time frame: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
The scale consists of 16 items and evaluates the positive and negative life changes experienced as a result of caregiving, ranging from the best direction (+3) to the worst direction (-3) (min. 15, max. 105). The scale has no subdimensions. As the total score obtained from the scale increases, it indicates a 'positive change,' while a decrease in the score indicates a 'negative change.' The Turkish validity and reliability study of the scale was conducted by Can and Cavlak in 2010. In that study, the internal consistency coefficient of the scale was found to be 0.90, and the test-retest reliability was 0.961.
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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.
MUKADDER MOLLAOĞLU, Prof.Dr. study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and Materials in people with Stroke Patients and Their Caregivers, run by Cumhuriyet 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 4 inclusion and 4 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 10 Jun 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?
Personal Information Form for Caregivers (time frame: This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.). The study lists 3 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 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.