Effects of Training Caregivers on the Outcomes of Stroke Survivors and Caregivers in Zimbabwe
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|ClinicalTrials.gov Identifier: NCT02569099|
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Caregiver training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||376 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomised Controlled Study to Compare the Effects of Standardised Care Plus Conventional Care Versus Conventional Care Only on the Outcomes of Stroke Survivors (HIV+ and HIV-) and Their Family Caregivers in Harare and Chitungwiza|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||May 15, 2017|
Experimental: Intervention using standardised care
Caregiver training /standardised care: where the participants (caregivers)s are trained on caring for relative who has survived a stroke once only for one hour using a developed curriculum.
Plus Conventional care: where the participants continue to receive the usual care as offered in protocols for treatment of stroke in Zimbabwe.
Other: Caregiver training
One hour training of family caregivers on the basic function of the brain and the stroke condition and its management in the home.
No Intervention: Control
No training offered to caregivers but conventional care only where the people who have survived a stroke receive the usual care as offered in protocols for treatment of stroke in Zimbabwe.
- Quality of life of stroke patients and family caregivers using the Euroqol - Five Dimensions (EQ-5D) [ Time Frame: Change from baseline EQ-5D at 12 months ]Health related quality of life tested using the Euroqol - Five Dimensions (EQ-5D)
- burden of care of family caregivers [ Time Frame: Change from baseline Caregiver Strain Index (CSI) at 12 months ]Changes in caregiver strain experienced by family caregivers over time
- Functional outcome of stroke patients [ Time Frame: Change from baseline Functional Independence Measure (FIM) at 12months ]Changes in level of function of stroke patients over time using the Functional Independence Measure (FIM)
- Community reintegration of stroke patients [ Time Frame: At 3 months and 12 months ]Determining whether patient was reintegrated into community
- Socio demographic characteristics of the participants [ Time Frame: Change from baseline scoidemographic characteristics at 12 months ]There may be changes that occur to these over time such as marital status and place of residence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569099
|University of Zimbabwe|
|Principal Investigator:||Farayi Kaseke, Masters||University of Zimbabwe|