StrokeCARE-LUTSNCT07480642
Caregiver Burden and Psychological Outcomes in Caregivers of Stroke Patients With Lower Urinary Tract Symptoms
An observational study of Stroke and Fatigue Syndrome, Chronic, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to evaluate caregiver burden, fatigue, sleep quality, and depression among family caregivers of stroke patients with lower urinary tract symptoms (LUTS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Fatigue Syndrome, Chronic, Caregiver
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Dec 2024
- Phase
- Observational
- 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
Study population: Family caregivers of stroke patients with lower urinary tract symptoms who were admitted to the Physical Medicine and Rehabilitation outpatient clinic between June 2023 and June 2024 were included in this study. Caregivers who met the eligibility criteria and agreed to participate completed questionnaires assessing caregiver burden, fatigue, sleep quality, depression, and caregiving reactions.
Who may be able to join
- Adult family caregivers (≥18 years old) providing care for patients with stroke who have lower urinary tract symptoms.
- Caregivers who have been providing care for at least 3 months.
- Caregivers who are able to read and understand the questionnaires.
- Caregivers who voluntarily agree to participate in the study.
Who cannot join
- Caregivers with a previously diagnosed severe psychiatric disorder.
- Caregivers with cognitive impairment preventing completion of questionnaires.
- Caregivers who declined participation or provided incomplete questionnaire data.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler physical therapy and rehabilitation
Ankara, Yenimahalle, 06680
About this study
Official title: Caregiver Burden, Fatigue, Sleep Quality, and Depression in Family Caregivers of Stroke Patients With Lower Urinary Tract Symptoms: A Cross-Sectional Study
This cross-sectional observational study aims to evaluate caregiver burden, fatigue, sleep quality, and depression among family caregivers of stroke patients with lower urinary tract symptoms (LUTS). Stroke survivors frequently experience urinary dysfunction, which may increase caregiving demands and negatively affect caregiver well-being. A total of 70 family caregivers of stroke patients with LUTS receiving inpatient or outpatient rehabilitation care were included. Caregiver outcomes were assessed using validated instruments including the Caregiver Strain Index (CSI), Fatigue Severity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory (BDI). The study also examined the relationship between caregiver outcomes and patient-related clinical variables such as stroke severity and cognitive status.
- Conditions
- Stroke, Fatigue Syndrome, Chronic, Caregiver
- Medical subject headings
- Stroke, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers of Stroke Patients With LUTS | Family caregivers of stroke patients with lower urinary tract symptoms receiving inpatient or outpatient rehabilitation care. Caregiver burden, fatigue, sleep quality, and depression were assessed using validated questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver burden measured by the Caregiver Strain Index (CSI)
The Caregiver Strain Index (CSI) is a validated questionnaire used to assess caregiver burden. It consists of 13 items evaluating strain related to caregiving activities. Higher scores indicate greater caregiver burden
Measured: Baseline
Secondary outcomes (4)
Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a validated instrument used to assess sleep quality and disturbances over the past month. Higher scores indicate poorer sleep quality
Measured: baseline
Depression measured by the Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a widely used self-report instrument that assesses depressive symptoms. Higher scores indicate greater depression severity.
Measured: baseline
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire used to assess the severity and impact of fatigue on daily functioning. Higher scores indicate greater fatigue severity.
Measured: baseline
Caregiving Reactions Questionnaire
The Caregiving Reactions Questionnaire is a self-report instrument used to assess caregivers' emotional and psychological reactions associated with providing care to a family member with a chronic health condition.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- SEFA G ASLAN, Principal investigator, gaziler physcial therapy and rehabilitation hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480642
- Sponsor's protocol ID
- GPHR-LUTS-70
- Acronym
- CARE-LUTS
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden, Fatigue, Sleep Quality, and Depression in Family Caregivers of Stroke Patients With Lower Urinary Tract Symptoms: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07480642
- Acronym / sponsor ID
- CARE-LUTS / GPHR-LUTS-70
- Conditions
- Stroke, Fatigue Syndrome, Chronic, Caregiver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Mar 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.
This cross-sectional observational study aims to evaluate caregiver burden, fatigue, sleep quality, and depression among family caregivers of stroke patients with lower urinary tract symptoms (LUTS). Stroke survivors frequently experience urinary dysfunction, which may increase caregiving demands and negatively affect caregiver well-being. A total of 70 family caregivers of stroke patients with LUTS receiving inpatient or outpatient rehabilitation care were included. Caregiver outcomes were assessed using validated instruments including the Caregiver Strain Index (CSI), Fatigue Severity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory (BDI). The study also examined the relationship between caregiver outcomes and patient-related clinical variables such as stroke severity and cognitive status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers of Stroke Patients With LUTS | – | –Family caregivers of stroke patients with lower urinary tract symptoms receiving inpatient or outpatient rehabilitation care. Caregiver burden, fatigue, sleep quality, and depression were assessed using validated questionnaires. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Family caregivers of stroke patients with lower urinary tract symptoms who were admitted to the Physical Medicine and Rehabilitation outpatient clinic between June 2023 and June 2024 were included in this study. Caregivers who met the eligibility criteria and agreed to participate completed questionnaires assessing caregiver burden, fatigue, sleep quality, depression, and caregiving reactions.
Key inclusion criteria (4 listed)
- Adult family caregivers (≥18 years old) providing care for patients with stroke who have lower urinary tract symptoms.
- Caregivers who have been providing care for at least 3 months.
- Caregivers who are able to read and understand the questionnaires.
- Caregivers who voluntarily agree to participate in the study.
Key exclusion criteria (3 listed)
- Caregivers with a previously diagnosed severe psychiatric disorder.
- Caregivers with cognitive impairment preventing completion of questionnaires.
- Caregivers who declined participation or provided incomplete questionnaire data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caregiver burden measured by the Caregiver Strain Index (CSI)
Time frame: Baseline
The Caregiver Strain Index (CSI) is a validated questionnaire used to assess caregiver burden. It consists of 13 items evaluating strain related to caregiving activities. Higher scores indicate greater caregiver burden
4 secondary outcomes
Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline
Depression measured by the Beck Depression Inventory (BDI)
Time frame: baseline
Fatigue Severity Scale (FSS)
Time frame: baseline
Caregiving Reactions Questionnaire
Time frame: baseline
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 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
SEFA G ASLAN principal investigator
gaziler physcial therapy and rehabilitation hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Fatigue Syndrome, Chronic, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 3 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 18 Mar 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?
Caregiver burden measured by the Caregiver Strain Index (CSI) (time frame: Baseline). 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 18 Mar 2026.