Caregiver Burden and Psychological Outcomes in Caregivers of Stroke Patients With Lower Urinary Tract Symptoms

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Caregiver Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziler physical therapy and rehabilitation

Ankara, Yenimahalle, 06680, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Secondary outcomes

Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)

Time frame: baseline

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
Depression measured by the Beck Depression Inventory (BDI)

Time frame: baseline

The Beck Depression Inventory (BDI) is a widely used self-report instrument that assesses depressive symptoms. Higher scores indicate greater depression severity.
Fatigue Severity Scale (FSS)

Time frame: baseline

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.
Caregiving Reactions Questionnaire

Time frame: baseline

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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Caregiver Burden, Fatigue, Sleep Quality, and Depression in Family Caregivers of Stroke Patients With Lower Urinary Tract Symptoms: A Cross-Sectional Study

Acronym: CARE-LUTS

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 18, 2026
Registry last updated: Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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