Impact of the Training to Aid Patients With Stroke Program on Caregiver Knowledge, Burden, and Quality of Life
29 de mayo de 2026 actualizado por: Dave Albert D. Patrimonio, University of the Philippines Manila - Philippine General Hospital
Impact of the Training to Aid Patients With Stroke Program on Caregiver Knowledge, Burden, and Quality of Life: A Pilot Study
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:
- Does participation in the TAP-S Program improve caregiver knowledge regarding stroke management, rehabilitation, and home care?
- Does participation in the TAP-S Program reduce caregiver burden and improve caregiver quality of life across multiple assessment phases?
Participants will:
- 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.
- Complete outcome assessments at baseline (pre-intervention), immediately post-intervention, and two weeks post-discharge.
- Answer questionnaires measuring caregiver knowledge, caregiver strain, and quality of life.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
National Capital Region
-
Manila, National Capital Region, Filipinas, 1000
- University of the Philippines Philippine General Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in caregiver knowledge scores following participation in the Training to Aid Patients With Stroke (TAP-S) Program
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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Baseline, immediately post-intervention, and two weeks post-discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Silla de estudio: Cynthia D. Ang, Doctor of Medicine, Department of Rehabilitation Medicine, Philippine General Hospital, University of the Philippines Manila
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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)
- 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.
- 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
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de noviembre de 2025
Finalización primaria (Actual)
26 de enero de 2026
Finalización del estudio (Actual)
26 de enero de 2026
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-0344-01
- PHRR260301-009736 (Identificador de registro: Philippine Health Research Registry)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .