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Effects of Training Caregivers on the Outcomes of Stroke Survivors and Caregivers in Zimbabwe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569099
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Farayi Kaseke, University of Zimbabwe

Brief Summary:
The burden of stroke has continued to increase in Zimbabwe in the last 3 decades. resulting in increased burden of care to family caregivers. Caregivers who had cared for survivors for periods exceeding 3 months indicated desire to be taught about basic care before they were discharged from hospital and a curriculum of training based on a targeted needs analysis was developed. One arm of the study will receive caregivers training as the intervention and the other arm will be the control. The outcome of both the caregivers and survivors will be compared based on selected tools. Data will be collected at baseline (at most 2 weeks after suffering a stroke) the participants will be followed up at 3 and 12 months post stroke.

Condition or disease Intervention/treatment Phase
Stroke Other: Caregiver training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Community reintegration of stroke patients [ Time Frame: At 3 months and 12 months ]
    Determining whether patient was reintegrated into community


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

List of Inclusion Criteria:

  1. First ever confirmed clinical diagnosis of stroke. All patients diagnosed of stroke and who are 18 years and above will be recruited.
  2. The stroke patients are likely to return home with residual disability
  3. Both males and females are eligible and should be residing in Harare and Chitungwiza communities during the period of study.
  4. Stroke survivors must have a family caregiver
  5. HIV status may or may not be known
  6. Care giver is willing and able to provide support after discharge
  7. Fulfills the research definition of a family care giver

list of Exclusion criteria:

  1. Stroke patients with other diagnoses of neurological origin and a previous neurological disorder and orthopedic conditions that hamper treatment are not eligible to participate.
  2. Patients with a history of psychiatric illness will be excluded.

Information from the National Library of Medicine

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


Locations
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Zimbabwe
University of Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
University of Zimbabwe
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Farayi Kaseke, Masters University of Zimbabwe
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Responsible Party: Farayi Kaseke, Research Director, University of Zimbabwe
ClinicalTrials.gov Identifier: NCT02569099    
Other Study ID Numbers: UZimbabwe
ID43TWOO9539-03 ( Other Grant/Funding Number: University of California, Berkeley (FOGARTY) )
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: through publication of results and conference presentations.
Keywords provided by Farayi Kaseke, University of Zimbabwe:
stroke survivors
caregivers
burden of care
quality of life
function
community reintegration
caregiver training
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases