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NCT Number: NCT07617207

Impact of the Training to Aid Patients With Stroke Program on Caregiver Knowledge, Burden, and Quality of Life

The goal of this clinical trial is to evaluate the effect of the Training to Aid Patients with Stroke (TAP-S) Program on caregiver outcomes among informal caregivers of adult stroke patients during the early post-stroke period. The main questions it aims to answer are:

1. Does participation in the TAP-S Program improve caregiver knowledge regarding stroke management, rehabilitation, and home care? 2. Does participation in the TAP-S Program reduce caregiver burden and improve caregiver quality of life across multiple assessment phases?

Participants will:

1. Attend a structured caregiver education and training program covering basic stroke care, rehabilitation principles, positioning, transfers, home exercises, prevention of complications, and caregiver self-care. 2. Complete outcome assessments at baseline (pre-intervention), immediately post-intervention, and two weeks post-discharge. 3. Answer questionnaires measuring caregiver knowledge, caregiver strain, and quality of life.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Quality of Life Stroke Rehabilitation Stroke Rehabilitation and Caregivers Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Philippines Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Caregivers of adult patients diagnosed with stroke
  • Caregivers of patients admitted to the inpatient rehabilitation or neurology services during the study period
  • Caregivers directly involved in providing daily care to the stroke patient
  • Caregivers aged 18 years and older
  • Caregivers able to understand and communicate in Filipino or English

Exclusion criteria

  • Caregivers of patients with unstable medical conditions that prevented completion of the intervention or assessments
  • Caregivers unable to attend the educational sessions or follow-up assessments
  • Caregivers with significant cognitive, hearing, or communication impairments limiting participation
  • Professional or paid caregivers not primarily responsible for the patient's care

Treatment and study plan

Training to Aid Patients with Stroke (TAP-S) Program

Behavioral

A structured caregiver education and training program designed to improve caregiver knowledge, reduce caregiver burden, and enhance quality of life among informal caregivers of stroke patients through multidisciplinary instruction, demonstrations, and supervised practical training sessions.

Primary outcomes

  1. Change in caregiver knowledge scores following participation in the Training to Aid Patients With Stroke (TAP-S) Program

    Time frame: Baseline, immediately post-intervention, and two weeks post-discharge

    Caregiver knowledge regarding stroke, rehabilitation principles, and home care will be assessed using a structured 15-item caregiver knowledge questionnaire developed by the study investigators based on established stroke rehabilitation, caregiver education, and home care recommendations. The questionnaire was designed to evaluate caregivers' understanding of stroke management, prevention of complications, rehabilitation principles, and safe home-based care practices. Prior to implementation, the questionnaire underwent expert review by rehabilitation medicine professionals for content validity. Total scores range from 0 to 15, with higher scores indicating greater caregiver knowledge and understanding of stroke management and home care.

  2. Change in caregiver burden following participation in the Training to Aid Patients With Stroke (TAP-S) Program

    Time frame: Baseline, immediately post-intervention, and two weeks post-discharge

    Caregiver burden will be assessed using the Modified Caregiver Strain Index (MCSI), a 13-item instrument that evaluates strain related to caregiving across physical, psychological, social, personal, and financial domains. Each item is scored as 0 ("No"), 1 ("Sometimes"), or 2 ("Yes"), resulting in a total score ranging from 0 to 26. Higher scores indicate greater caregiver strain and burden.

  3. Change in caregiver quality of life following participation in the Training to Aid Patients With Stroke (TAP-S) Program

    Time frame: Baseline, immediately post-intervention, and two weeks post-discharge

    Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), a 26-item validated instrument that evaluates four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Items are rated on a 5-point Likert scale, with raw domain scores transformed according to WHO guidelines to a scale ranging from 0 to 100. Higher scores indicate better perceived quality of life. The Physical Health domain ranges from 0-100, the Psychological Health domain ranges from 0-100, the Social Relationships domain ranges from 0-100, and the Environment domain ranges from 0-100, with each domain analyzed separately across assessment phases.

Sponsors and collaborators

Lead sponsor

University of the Philippines Manila - Philippine General Hospital

Other

Registry information

Official study title

Impact of the Training to Aid Patients With Stroke Program on Caregiver Knowledge, Burden, and Quality of Life: A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 3, 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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