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| ID | Type | Description | Link |
|---|---|---|---|
| PHRR260301-009736 | Registry Identifier | Philippine Health Research Registry |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia D. Ang, Doctor of Medicine | Department of Rehabilitation Medicine, Philippine General Hospital, University of the Philippines Manila | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Philippines Philippine General Hospital | Manila | National Capital Region | 1000 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27017120 | Background | 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. | |
| 34496626 | 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. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 11, 2025 |
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| Baseline, immediately post-intervention, and two weeks post-discharge |
| 40868655 | 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. |
| 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) |
| 31473982 | 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. |
| 34737502 | 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. |
| 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 |
| 40062006 | 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. |
| 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 |
| 39308875 | 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. |
| 30936715 | 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. |
| 39664630 | 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. |
| 38020842 | 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. |
| 31406848 | 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. |
| 26605179 | 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. |
| 38470676 | 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. |
| 34484093 | 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. |
| May 28, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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