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

29 maj 2026 uppdaterad av: 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:

  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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

22

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of the Philippines Manila - Philippine General Hospital

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 november 2025

Primärt slutförande (Faktisk)

26 januari 2026

Avslutad studie (Faktisk)

26 januari 2026

Studieregistreringsdatum

Först inskickad

21 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

1 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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