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

NCT02569099 | Completed DMC

• 2 other identifiers: UZimbabweID43TWOO9539-03
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke survivors; caregivers; burden of care; quality of life; function; community reintegration; caregiver training

Outcome Measures

Primary Outcomes (1)

• Quality of life of stroke patients and family caregivers using the Euroqol - Five Dimensions (EQ-5D)

  Health related quality of life tested using the Euroqol - Five Dimensions (EQ-5D)

  Change from baseline EQ-5D at 12 months

Secondary Outcomes (3)

• burden of care of family caregivers

  Change from baseline Caregiver Strain Index (CSI) at 12 months

• Functional outcome of stroke patients

  Change from baseline Functional Independence Measure (FIM) at 12months

• Community reintegration of stroke patients

  At 3 months and 12 months

Other Outcomes (1)

• Socio demographic characteristics of the participants

  Change from baseline scoidemographic characteristics at 12 months

Study Arms (2)

Intervention using standardised care

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Caregiver training OTHER

One hour training of family caregivers on the basic function of the brain and the stroke condition and its management in the home.

Intervention using standardised care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zimbabwe: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Zimbabwe

Harare, Zimbabwe

Location

Related Publications (1)

• Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

  PMID: 34813082 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Farayi Kaseke, Masters

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: October 6, 2015
• Study Start: October 1, 2014
• Primary Completion: April 30, 2017
• Study Completion: May 15, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

ZI (1)