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

Stroke Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

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 all — Click 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