AzTrials
AzTrials

StrokeNCT06341881

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

A study testing Transitional Care Training Program in people with Stroke and Stroke, Ischemic, run by Khyber Medical University Peshawar at 3 sites in Pakistan.

Completed

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

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
What is being tested?
Transitional Care Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesPakistan
Study dates
15 Jul 2024to 25 Mar 2025
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Family Caregivers who are not willing to participate in the study
  • Caregivers who has taken with any training regarding the stroke transitional care

Trial locations and contacts

3 sites in 1 country.

Pakistan3 sites

  • MTI- Lady Reading Hospital (LRH)

    Peshawar, Khyber Pakhtunkhwa, 25000

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

    Peshawar, Khyber Pakhtunkhwa, 25000

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

    Peshawar, Khyber Pakhtunkhwa, 25000

Other trials in Pakistan

About this study

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

Read the 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.

Being tested
Transitional Care Training Program
Keywords
Stroke, Geriatrics, Family caregivers, Needs assessment, Nursing, Home care
Medical subject headings
Stroke, Ischemic Stroke, Hemorrhagic Stroke

What participants receive

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

  • Transitional Care Training ProgramBehavioural

    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.

Study groups in NCT06341881
Study groupRoleWhat they receive
Intervention GroupExperimentalA total of 30 participants would be exposed to the nursing care training (intervention) randomly.
Receives: Behavioral: Transitional Care Training Program
Control GroupNo interventionA 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 being measured

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

  1. Physical care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire

    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.

    Measured: Upto 7 months

  2. Psychological care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire

    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.

    Measured: Upto 7 months

  3. Social Care measured via Training Evaluation Assessment Checklist (TEAC)

    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.

    Measured: Upto 7 months

  4. Training Need Assessment

    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.

    Measured: Upto 2 months

  5. Training Program Development

    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.

    Measured: Upto 2 months

Timeline

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

  1. First posted2 Apr 2024
  2. Study start15 Jul 2024
  3. Primary completion10 Feb 2025
  4. Study completion25 Mar 2025

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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341881
Sponsor's protocol ID
KMU/DIR/CTU/2024/006
Other IDs
KMU-CTU-2024-2001
Status last verified
Jun 2025
First submitted
18 Mar 2024
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36550813

  • 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.

    PubMed 29037005

  • 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.

    PubMed 34756176

  • 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.

    PubMed 29791947

  • 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.

    PubMed 30050573

  • 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.

    PubMed 29578827

  • 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.

    PubMed 30894836

  • 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.

    PubMed 26882958

  • 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.

    PubMed 31564238

  • 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.

    PubMed 31205230

  • 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.

    PubMed 36274666

  • 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.

    PubMed 26092476

Questions about this trial

What is this clinical trial studying?

A study testing Transitional Care Training Program in people with Stroke and Stroke, Ischemic, run by Khyber Medical University Peshawar at 3 sites in Pakistan.

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 4 inclusion and 2 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Pakistan. 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?

Physical care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire (time frame: Upto 7 months). The study lists 5 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 NCT06341881, which also lists 12 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 24 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in