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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02569099 |
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Date of registration:
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27/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Training Caregivers on the Outcomes of Stroke Survivors and Caregivers in Zimbabwe
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Scientific title:
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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 |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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376 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02569099 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Farayi Kaseke, Masters |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zimbabwe |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Other: Caregiver training
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Functional outcome of stroke patients
[Time Frame: Change from baseline Functional Independence Measure (FIM) at 12months]
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burden of care of family caregivers
[Time Frame: Change from baseline Caregiver Strain Index (CSI) at 12 months]
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Community reintegration of stroke patients
[Time Frame: At 3 months and 12 months]
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Secondary ID(s)
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ID43TWOO9539-03
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UZimbabwe
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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