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

NCT07617207 | Completed

• 2 other identifiers: 2025-0344-01PHRR260301-009736
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does participation in the TAP-S Program improve caregiver knowledge regarding stroke management, rehabilitation, and home care?
2. 2.Does participation in the TAP-S Program reduce caregiver burden and improve caregiver quality of life across multiple assessment phases?
3. 3.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.
4. 4.Complete outcome assessments at baseline (pre-intervention), immediately post-intervention, and two weeks post-discharge.
5. 5.Answer questionnaires measuring caregiver knowledge, caregiver strain, and quality of life.

Conditions

Stroke; Stroke Rehabilitation; Stroke Rehabilitation and Caregivers; Quality of Life

Keywords

Stroke rehabilitation; Caregiver training; Quality of life

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines Manila - Philippine General Hospital: lead

Study Sites (1)

University of the Philippines Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

Location

Related Publications (18)

• Chuluunbaatar E, Chou YJ, Pu C. Quality of life of stroke survivors and their informal caregivers: A prospective study. Disabil Health J. 2016 Apr;9(2):306-12. doi: 10.1016/j.dhjo.2015.10.007. Epub 2015 Dec 1.

  PMID: 27017120 BACKGROUND

• Pucciarelli G, Lyons KS, Petrizzo A, Ambrosca R, Simeone S, Alvaro R, Lee CS, Vellone E. Protective Role of Caregiver Preparedness on the Relationship Between Depression and Quality of Life in Stroke Dyads. Stroke. 2022 Jan;53(1):145-153. doi: 10.1161/STROKEAHA.120.034029. Epub 2021 Sep 9.

  PMID: 34496626 BACKGROUND

• Bartoli D, Petrosino F, Nuccio E, Damico V, Rago C, Veronese M, Virgolesi M, Alvaro R, Vellone E, Lombardi E, Pucciarelli G. The Impact of a Video-Educational and Tele-Supporting Program on the Caregiver-Stroke Survivor Dyad During Transitional Care (D-STEPS: Dyadic Support Through Tele-Health and Educational Programs in Stroke Care): A Longitudinal Study Protocol. Healthcare (Basel). 2025 Aug 18;13(16):2039. doi: 10.3390/healthcare13162039.

  PMID: 40868655 BACKGROUND

• Gurjar DNR. Effectiveness of Educational Program on Knowledge and Competence of Home Care Of Stroke Patients among Care Givers. In. 2020 [cited 2026 Feb 27]. Available from: https://www.semanticscholar.org/paper/Effectiveness-of-Educational-Program-on-Knowledge-Gurjar/e2772da72eb3c27810a17965b6787b94ecc9a5c0

  BACKGROUND

• Thayyil MM, Parthasarathy NB, Khanna M. Evaluating the Impact of a Psychoeducation Program on Knowledge of Caregivers for Stroke Survivors: A Longitudinal Study. Vol. 4. 2024;4(6)

  BACKGROUND

• Deyhoul N, Vasli P, Rohani C, Shakeri N, Hosseini M. The effect of family-centered empowerment program on the family caregiver burden and the activities of daily living of Iranian patients with stroke: a randomized controlled trial study. Aging Clin Exp Res. 2020 Jul;32(7):1343-1352. doi: 10.1007/s40520-019-01321-4. Epub 2019 Aug 31.

  PMID: 31473982 BACKGROUND

• Tiwari S, Joshi A, Rai N, Satpathy P. Impact of Stroke on Quality of Life of Stroke Survivors and Their Caregivers: A Qualitative Study from India. J Neurosci Rural Pract. 2021 Sep 22;12(4):680-688. doi: 10.1055/s-0041-1735323. eCollection 2021 Oct.

  PMID: 34737502 BACKGROUND

• Garrett-Jones EC, Anakor EA, Mamin FA, Fatema UK, Das SK. The long-term challenges faced by stroke survivors and their caregivers following a stroke in Bangladesh: a qualitative study. Journal of Global Health Reports. 2019 Nov 21;3:e2019053

  BACKGROUND

• Zhou J, Chen QL, Li QQ, Liu LM, Lei Y, Yang X, Mou WX, He CY, Li FM. Correlation Between the Quality of Life of Stroke Caregivers and the Readiness of Patients and Caregivers for Hospital Discharge. Patient Prefer Adherence. 2025 Mar 3;19:569-582. doi: 10.2147/PPA.S497604. eCollection 2025.

  PMID: 40062006 BACKGROUND

• Gonzalez-Suarez C, Grimmer K, Alipio I, Anota-Canencia EG, Santos-Carpio ML, Dizon JM, et al. Stroke Rehabilitation in the Philippines: An Audit Study. Disability, CBR and Inclusive Development. 2015 Sep 1;26(3):44-67

  BACKGROUND

• Felipe-Dimog EB, Realce Tumulak MJ, Garcia AP, Liang FW, Silao CLT, Hsu MT, Saragih ID, Sia-Ed AB. Caring Behavior of Filipinos toward their Elderly Family Members. Acta Med Philipp. 2024 Aug 30;58(15):6-10. doi: 10.47895/amp.vi0.6880. eCollection 2024.

  PMID: 39308875 BACKGROUND

• Hekmatpou D, Mohammad Baghban E, Mardanian Dehkordi L. The effect of patient care education on burden of care and the quality of life of caregivers of stroke patients. J Multidiscip Healthc. 2019 Mar 20;12:211-217. doi: 10.2147/JMDH.S196903. eCollection 2019.

  PMID: 30936715 BACKGROUND

• Gelisanga MAP, Ocden JHA, Angeles JVS. Duration of In-patient Physical Therapy at a Tertiary Hospital: Implications of a Time and Motion Study. Acta Med Philipp. 2024 Nov 15;58(20):98-106. doi: 10.47895/amp.v58i20.9535. eCollection 2024.

  PMID: 39664630 BACKGROUND

• Deepradit S, Powwattana A, Lagampan S, Thiangtham W. Effectiveness of a family-based program for post-stroke patients and families: A cluster randomized controlled trial. Int J Nurs Sci. 2023 Sep 27;10(4):446-455. doi: 10.1016/j.ijnss.2023.09.020. eCollection 2023 Oct.

  PMID: 38020842 BACKGROUND

• Dharma KK, Damhudi D, Yardes N, Haeriyanto S. Increase in the functional capacity and quality of life among stroke patients by family caregiver empowerment program based on adaptation model. Int J Nurs Sci. 2018 Sep 7;5(4):357-364. doi: 10.1016/j.ijnss.2018.09.002. eCollection 2018 Oct 10.

  PMID: 31406848 BACKGROUND

• Lee KW, Choi SJ, Kim SB, Lee JH, Lee SJ. A Survey of Caregivers' Knowledge About Caring for Stroke Patients. Ann Rehabil Med. 2015 Oct;39(5):800-15. doi: 10.5535/arm.2015.39.5.800. Epub 2015 Oct 26.

  PMID: 26605179 BACKGROUND

• Tziaka E, Tsiakiri A, Vlotinou P, Christidi F, Tsiptsios D, Aggelousis N, Vadikolias K, Serdari A. A Holistic Approach to Expressing the Burden of Caregivers for Stroke Survivors: A Systematic Review. Healthcare (Basel). 2024 Feb 29;12(5):565. doi: 10.3390/healthcare12050565.

  PMID: 38470676 BACKGROUND

• Collantes MV, Zuniga YH, Granada CN, Uezono DR, De Castillo LC, Enriquez CG, Ignacio KD, Ignacio SD, Jamora RD. Current State of Stroke Care in the Philippines. Front Neurol. 2021 Aug 17;12:665086. doi: 10.3389/fneur.2021.665086. eCollection 2021.

  PMID: 34484093 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cynthia D. Ang, Doctor of Medicine

  Department of Rehabilitation Medicine, Philippine General Hospital, University of the Philippines Manila

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: November 11, 2025
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)