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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06341881
Other study ID # KMU/DIR/CTU/2024/006
Secondary ID KMU-CTU-2024-200
Status Recruiting
Phase N/A
First received
Last updated
Start date February 27, 2024
Est. completion date January 2025

Study information

Verified date March 2024
Source Khyber Medical University Peshawar
Contact Sardar Ali, PhD Nursing Scholar
Phone +92 349-5182270
Email sardar.ins@kmu.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 2025
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Behavioral:
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.

Locations

Country Name City State
Pakistan Khyber Medical University Peshawar Khyber Pakhtunkhwa
Pakistan MTI-HMC (Medical Teaching Institution-Hayatabad Medical Complex), -Peshawar Peshawar Khyber Pakhtunkhwa
Pakistan MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan Peshawar Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor Collaborator
Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet Public Health. 2022 Jan;7(1):e14. — View Citation

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. — View Citation

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. Erratum In: J Stroke. 2018 Jan;20(1):142. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Upto 7 months
Primary 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. Upto 7 months
Primary 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. Upto 7 months
Primary 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. Upto 2 months
Primary 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. Upto 2 months
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