- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07617207
Impact of the Training to Aid Patients With Stroke Program on Caregiver Knowledge, Burden, and Quality of Life
29 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
22
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
National Capital Region
-
Manila, National Capital Region, Filippine, 1000
- University of the Philippines Philippine General Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in caregiver knowledge scores following participation in the Training to Aid Patients With Stroke (TAP-S) Program
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Cattedra di studio: Cynthia D. Ang, Doctor of Medicine, Department of Rehabilitation Medicine, Philippine General Hospital, University of the Philippines Manila
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 novembre 2025
Completamento primario (Effettivo)
26 gennaio 2026
Completamento dello studio (Effettivo)
26 gennaio 2026
Date di iscrizione allo studio
Primo inviato
21 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 maggio 2026
Primo Inserito (Effettivo)
1 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-0344-01
- PHRR260301-009736 (Identificatore di registro: Philippine Health Research Registry)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .