- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06341881
Understanding the Need and Feasibility of Transitional Care Training Program Among Family Caregivers of Geriatric Stroke Survivors in Pakistan
June 23, 2025 updated by: Dr. Najma Naz, Khyber Medical University Peshawar
The main intention of the study is to understand the need and feasibility of transitional care training program among family caregivers of geriatric stroke survivors in Pakistan
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to explore the training needs of family caregivers of caring their elderly stroke patients at homes in Pakistan.
Secondly the study aims to develop transitional care training program based on the identified needs for family caregivers of geriatric stroke survivors.
Furthermore; the study intends to evaluate the feasibility/efficacy of transitional care training program among family caregivers of geriatric stroke survivors.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- MTI- Lady Reading Hospital (LRH)
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- MTI-HMC (Medical Teaching Institution-Hayatabad Medical Complex), -Peshawar
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Family caregivers of both genders geriatric stroke survivors will be included
- Family caregivers who care patients both with the Ischemic/hemorrhagic stroke
- Caregivers who have taken care of the patient at least with 1-time hospitalization
- Family caregivers who have taken care for at least 1-weeks at home.
Exclusion Criteria:
- Family Caregivers who are not willing to participate in the study
- Caregivers who has taken with any training regarding the stroke transitional care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
A total of 30 participants would be exposed to the nursing care training (intervention) randomly.
|
A nursing based transitional care training intervention would be carried out to prepare the family caregivers to take care of their elderly stroke survivors at home.
The intervention would be carried out for a tentative time of 2 to 3 hours to educate the family caregivers at their homes after hospitalization.
The study participants would be evaluated after 8 weeks of the intervention.
A structured, validated and literature based assessment checklist will be devised to assess the usefulness and feasibility of the intervention.
Assistance of senior nurses and health professionals, specialized in stroke care will be taken during the training part of the program.
|
|
No Intervention: Control Group
A sample of 30 study participants would not be exposed to the training and would be kept in the control group.
They would be a group who would receive usual care and routine awareness by their health care professionals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire
Time Frame: Upto 7 months
|
Physical care of the geriatric population having a stroke will be evaluated using the physical care section of the standardized Training evaluation assessment checklist (TEAC) questionnaire developed from the qualitative work package of the protocol.
This part of the questionnaire includes Hygiene care, range of motion, Bedsore prevention, falls prevention, medication administration, dietary care and elimination care etc.
The mean scores will be calculated for the overall population to find the effectiveness of the training program for the geriatric stroke population as compared to the control group.
|
Upto 7 months
|
|
Psychological care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire
Time Frame: Upto 7 months
|
Psychological care of the geriatric with stroke will be assessed using a psychological section of the standardized Training Evaluation Assessment Checklist (TEAC) questionnaire developed from the qualitative work package of the protocol.
This part of the questionnaire includes evaluation of the psychological needs and stress management activities.
The mean scores will be calculated for the overall population to find the effectiveness of the training program for the geriatric stroke population as compared to the control group.
|
Upto 7 months
|
|
Social Care measured via Training Evaluation Assessment Checklist (TEAC)
Time Frame: Upto 7 months
|
Social care of the geriatric population with stroke will be assessed using a social care section of the standardized Training Evaluation Assessment Checklist (TEAC) questionnaire developed from the qualitative work package of the protocol.
In this domain, TEAC questionnaire includes questions related to social care and spiritual care.
The mean scores will be calculated for the overall population to find the effectiveness of the training program for the geriatric stroke population as compared to the control group.
|
Upto 7 months
|
|
Training Need Assessment
Time Frame: Upto 2 months
|
To explore the training needs of family caregivers of caring their elderly stroke patients at homes in Pakistan.
(Qualitative Exploration).
Training needs of the study participants would be explored qualitatively with the study guided questions.
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Upto 2 months
|
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Training Program Development
Time Frame: Upto 2 months
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To develop transitional care training program based on the identified needs for family caregivers of geriatric stroke survivors.
(Based on qualitative parameters during need assessment).
A nursing based transitional care training intervention would be planned to prepare family care givers of geriatric stroke survivors.
|
Upto 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sardar Ali, PhD Nursing Scholar, Khyber Medical University Peshawar
- Study Director: Dildar Muhammad, PHD Nursing, Khyber Medical University Peshawar
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
- Cao LL, Tang YF, Xia YQ, Wei JH, Li GR, Mu XM, Jiang CZ, Jin QZ, He M, Cui LJ. A survey of caregiver burden for stroke survivors in non-teaching hospitals in Western China. Medicine (Baltimore). 2022 Dec 16;101(50):e31153. doi: 10.1097/MD.0000000000031153.
- Lui SK, Nguyen MH. Elderly Stroke Rehabilitation: Overcoming the Complications and Its Associated Challenges. Curr Gerontol Geriatr Res. 2018 Jun 27;2018:9853837. doi: 10.1155/2018/9853837. eCollection 2018.
- Caro CC, Costa JD, Da Cruz DMC. Burden and Quality of Life of Family Caregivers of Stroke Patients. Occup Ther Health Care. 2018 Apr;32(2):154-171. doi: 10.1080/07380577.2018.1449046. Epub 2018 Mar 26.
- Steigleder T, Kollmar R, Ostgathe C. Palliative Care for Stroke Patients and Their Families: Barriers for Implementation. Front Neurol. 2019 Mar 6;10:164. doi: 10.3389/fneur.2019.00164. eCollection 2019.
- Lou S, Carstensen K, Jorgensen CR, Nielsen CP. Stroke patients' and informal carers' experiences with life after stroke: an overview of qualitative systematic reviews. Disabil Rehabil. 2017 Feb;39(3):301-313. doi: 10.3109/09638288.2016.1140836. Epub 2016 Feb 17.
- Anwar A, Saleem S, Aamir A, Diwan M. Organization of Stroke Care in Pakistan. Int J Stroke. 2020 Jul;15(5):565-566. doi: 10.1177/1747493019879663. Epub 2019 Sep 30.
- Krishnan S, Hay CC, Pappadis MR, Deutsch A, Reistetter TA. Stroke Survivors' Perspectives on Post-Acute Rehabilitation Options, Goals, Satisfaction, and Transition to Home. J Neurol Phys Ther. 2019 Jul;43(3):160-167. doi: 10.1097/NPT.0000000000000281.
- Merati-Fashi F, Dalvandi A, Parsa Yekta Z. Stroke Survivors and Their Family Caregivers' Experiences of Health Information Seeking: A Qualitative Study. Int J Community Based Nurs Midwifery. 2022 Oct;10(4):269-278. doi: 10.30476/IJCBNM.2022.94489.1997.
- Venketasubramanian N, Yoon BW, Pandian J, Navarro JC. Stroke Epidemiology in South, East, and South-East Asia: A Review. J Stroke. 2017 Sep;19(3):286-294. doi: 10.5853/jos.2017.00234. Epub 2017 Sep 29.
- Owolabi MO, Thrift AG, Mahal A, Ishida M, Martins S, Johnson WD, Pandian J, Abd-Allah F, Yaria J, Phan HT, Roth G, Gall SL, Beare R, Phan TG, Mikulik R, Akinyemi RO, Norrving B, Brainin M, Feigin VL; Stroke Experts Collaboration Group. Primary stroke prevention worldwide: translating evidence into action. Lancet Public Health. 2022 Jan;7(1):e74-e85. doi: 10.1016/S2468-2667(21)00230-9. Epub 2021 Oct 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2024
Primary Completion (Actual)
February 10, 2025
Study Completion (Actual)
March 25, 2025
Study Registration Dates
First Submitted
March 18, 2024
First Submitted That Met QC Criteria
March 25, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
June 24, 2025
Last Update Submitted That Met QC Criteria
June 23, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMU/DIR/CTU/2024/006
- KMU-CTU-2024-2001 (Other Identifier: Khyber Medical University Clinical Trial Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring.
Data or samples shared will be coded, with no PHI included.
Prior permission of the investigators, participants and concerned departments will be obtained.
IPD Sharing Time Frame
Data requests can be submitted starting 12 months after article publication
IPD Sharing Access Criteria
Access can be requested by qualified researchers through proper approval of the investigators.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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