Understanding the Need and Feasibility of Transitional Care Training Program Among Family Caregivers of Geriatric Stroke Survivors in Pakistan

NCT ID: NCT06341881

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-03-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Stroke, Ischemic Stroke Hemorrhagic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The most commonly two armed parallel study design would be used to conduct the current study. The study participants in an intervention group would be compared with that of a control group. Equal number of Participants would be allocated with random assignment in the two groups.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
The study participants would not be informed of what group they are in. Independent outcome assessors would be utilized for the assessment. Further outcomes assessors and data analysts' would be kept unaware of intervention or group allocations to carry out their assessment after inclusion of participants into the study.

This study which includes three research sites will be taken as preliminary strata via the simple random sampling technique. Lottery method as one of the oldest and commonly used approach would then be followed to recruit the sample size. Screening of the participants would be taken place in the first round based on the inclusion and exclusion criteria. The eligible participants would be assigned with a code in the second round before recruiting the participant into the study. Lottery method (law of chance) would then be follow to allocate the participants randomly into treatment or control groups in the study sites.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

A total of 30 participants would be exposed to the nursing care training (intervention) randomly.

Group Type EXPERIMENTAL

Transitional Care Training Program

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transitional Care Training Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Khyber Medical University Peshawar

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Najma Naz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sardar Ali, PhD Nursing Scholar

Role: PRINCIPAL_INVESTIGATOR

Khyber Medical University Peshawar

Dildar Muhammad, PHD Nursing

Role: STUDY_DIRECTOR

Khyber Medical University Peshawar

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MTI- Lady Reading Hospital (LRH)

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

MTI-HMC (Medical Teaching Institution-Hayatabad Medical Complex), -Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36550813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29037005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34756176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29791947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30050573 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29578827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30894836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26882958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31564238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31205230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36274666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26092476 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMU-CTU-2024-2001

Identifier Type: OTHER

Identifier Source: secondary_id

KMU/DIR/CTU/2024/006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.