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

NCT07480642 | Completed

• 1 other identifier: GPHR-LUTS-70
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Secondary Outcomes (4)

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

  baseline

• Depression measured by the Beck Depression Inventory (BDI)

  baseline

• Fatigue Severity Scale (FSS)

  baseline

• Caregiving Reactions Questionnaire

  baseline

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler physical therapy and rehabilitation

Ankara, Yenimahalle, 06680, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• SEFA G ASLAN

  gaziler physcial therapy and rehabilitation hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assitant professor

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)