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

May 28, 2026 updated by: Dave Albert D. Patrimonio, University of the Philippines Manila - Philippine General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • National Capital Region
      • Manila, National Capital Region, Philippines, 1000
        • University of the Philippines Philippine General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training to Aid Patients with Stroke (TAP-S) Program Intervention Group
Participants in this arm received the TAP-S Program, a structured caregiver education and training intervention designed for informal caregivers of stroke patients. The program included lectures, demonstrations, and supervised practical training on stroke education, rehabilitation principles, positioning and transfers, home exercises, prevention of complications, activities of daily living assistance, and caregiver self-care.
Behavioral: Training to Aid Patients with Stroke (TAP-S) Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately post-intervention, and two weeks post-discharge
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.
Baseline, immediately post-intervention, and two weeks post-discharge
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.
Baseline, immediately post-intervention, and two weeks post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Philippines Manila - Philippine General Hospital

Investigators

  • Study Chair: Cynthia D. Ang, Doctor of Medicine, Department of Rehabilitation Medicine, Philippine General Hospital, University of the Philippines Manila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Actual)

January 26, 2026

Study Completion (Actual)

January 26, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0344-01
  • PHRR260301-009736 (Registry Identifier: Philippine Health Research Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared due to the inclusion of potentially identifiable and sensitive information, including demographic and caregiving-related data. De-identified data may be made available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe