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StrokeNCT07617207

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

A study testing Training to Aid Patients with Stroke (TAP-S) Program in people with Stroke and Stroke Rehabilitation, run by University of the Philippines Manila - Philippine General Hospital at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Training to Aid Patients with Stroke (TAP-S) Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 sitePhilippines
Study dates
11 Nov 2025to 26 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Philippines1 site
  • University of the Philippines Philippine General Hospital

    Manila, National Capital Region, 1000

Other trials in Philippines

About this study

Official title: 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?
Read more

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.
Being tested
Training to Aid Patients with Stroke (TAP-S) Program
Keywords
Stroke rehabilitation, Caregiver training, Quality of life
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training to Aid Patients with Stroke (TAP-S) ProgramBehavioural

    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.

Study groups in NCT07617207
Study groupRoleWhat they receive
Training to Aid Patients with Stroke (TAP-S) Program Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Training to Aid Patients with Stroke (TAP-S) Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, immediately post-intervention, and two weeks post-discharge

  2. 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.

    Measured: Baseline, immediately post-intervention, and two weeks post-discharge

  3. 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.

    Measured: Baseline, immediately post-intervention, and two weeks post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start11 Nov 2025
  3. Primary completion26 Jan 2026
  4. Study completion26 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07617207
Sponsor's protocol ID
2025-0344-01
Other IDs
PHRR260301-009736
Status last verified
May 2026
First submitted
21 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 27017120
  • 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.

    PubMed 34496626
  • 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.

    PubMed 40868655
  • 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)

  • 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.

    PubMed 31473982
  • 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.

    PubMed 34737502
  • 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.

    PubMed 40062006
  • 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.

    PubMed 39308875
  • 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.

    PubMed 30936715
  • 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.

    PubMed 39664630
  • 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.

    PubMed 38020842
  • 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.

    PubMed 31406848

Questions about this trial

What is this clinical trial studying?

A study testing Training to Aid Patients with Stroke (TAP-S) Program in people with Stroke and Stroke Rehabilitation, run by University of the Philippines Manila - Philippine General Hospital at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in caregiver knowledge scores following participation in the Training to Aid Patients With Stroke (TAP-S) Program (time frame: Baseline, immediately post-intervention, and two weeks post-discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07617207, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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