StrokeNCT02569099
Effects of Training Caregivers on the Outcomes of Stroke Survivors and Caregivers in Zimbabwe
A study testing Caregiver training in people with Stroke, run by University of Zimbabwe at 1 site in Zimbabwe.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Caregiver training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteZimbabwe
- Study dates
- Oct 2014to 15 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
List of Inclusion Criteria:
- 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 list of Exclusion criteria:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
SUMMARY
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 family caregivers in Harare and Chitungwiza.
RESEARCH QUESTION 1. What are the effects of a standardised care plus conventional care versus conventional care only on the outcomes of stroke survivors and family caregivers in Harare and Chitungwiza?
RATIONALE FOR RESEARCH
Randomising the participants (people that have survived a stroke and their family caregivers) into trained and untrained groups and following them up using standardised measurement tools will highlight the effect that training has on the quality of life of the stroke survivors and their caregivers as well as function and community reintegration of survivors and burden of care among the caregivers. It is expected this will provide evidence for the need to provide an intervention program that will support family caregivers and improve the outcomes of both. It is against this background that this study aims to determine the effect that a standardised caregiver training program has on the outcomes and quality of life of the caregivers and stroke survivors in Harare and Chitungwiza.
Objectives of the research
Broad Objective
1.To determine the effect of standardized care plus conventional care versus conventional care only on the outcomes of stroke survivors (HIV= and HIV-) and family caregivers over a 12 month period.
Specific Objectives
The objectives of the study were to compare the following in the two arms of the study over a 12 months period:
- quality of life of caregivers
- caregiver burden among caregivers
- functional levels of patients
- quality of life of stroke survivors
- community reintegration among stroke survivors.
- effect of the patient's HIV status on the outcomes of family caregivers.
- effect of the HIV status on the outcomes of stroke survivors.
METHODS This will be a prospective study where the researcher will recruit first ever sufferers of stroke and their family caregivers through hospitals in Harare and Chitungwiza, Zimbabwe. A baseline survey to describe the characteristics of stroke patients and the caregivers will be done at 2 to 14 days post stroke. Medical information about the patients will be taken from their medical records.
A standardized curriculum to train the primary caregivers of stroke patients has been developed using the Kern's six step approach to curriculum development for medical education and will be tested.
The outcomes of the stroke survivors and the family caregivers will then be compared in a randomized control trial with a conventional group to establish any differences.
Participants will be consecutively recruited and randomly allocated into the arm of study using computer generated random numbers. People who have suffered a stroke and admitted in the wards are identified through wards registers. Informed consent and assent for patients who cannot communicate will be sought. Baseline assessment on function and health related quality of life will be done at least 48 hours post stroke for patients. The caregivers who will most likely look after patients will be identified and after giving consent will be assessed on baseline caregiver burden and health related quality of life at recruitment. Research assistants who are trained will be blinded to the arm to which the patients and their caregivers belong. Another research assistant will allocate the participants into the intervention or control arms of the study and communicate with the caregivers for training appointments and the PI who will do all the training for intra-rater reliability.The caregivers are trained on caring for people who have survived a stroke before they are discharged home. The training will include both theoretical input and practical demonstrations. Handouts will be given for their reference later on. training will occur only once. Both the caregiver and patient are then followed up at three months and twelve months. The functional outcomes, quality of life and physical and social reintegration will be elicited from the patients while caregivers will be asked about caregiver burden and quality of life.
RISKS/BENEFITS TO SUBJECTS There will be no risks to the participants for taking part in the study. They would however benefit indirectly by providing useful information to the physiotherapy profession and thus enhance services delivered to them and others affected by stroke.
COST AND COMPENSATION INFORMED CONSENT The participants will not be required to pay anything and neither will they be compensated for taking part in the study.
INFORMED CONSENT Before taking part in the study, participants will be required to read, understand and sign the informed consent which is in Appendix C of the proposal.
CONFIDENTIALITY ASSURANCES The information provided by the participants and their names will not be divulged to anyone. The participants' names or any form of identification will not be required in the questionnaire. The completed questionnaires will be kept securely. The final report may include quotations from the questionnaire but they will be anonymous.
CONFLICT OF INTEREST There are no gains anticipated for carrying out this study except normal scholarly gains for which this study is being carried out.
COLLABORATIVE AGREEMENTS Letters of approval to conduct the study at the study settings are attached.
INTENDED RESULTS The results of the study will be used for purely academic purposes for the fulfillment of a Doctor of Philosophy (DPhil) in physiotherapy.
- Conditions
- Stroke
- Being tested
- Caregiver training
- Keywords
- stroke survivors, caregivers, burden of care, quality of life, function, community reintegration, caregiver training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver trainingOther
One hour training of family caregivers on the basic function of the brain and the stroke condition and its management in the home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline EQ-5D at 12 months
Secondary outcomes (3)
burden of care of family caregivers
Changes in caregiver strain experienced by family caregivers over time
Measured: Change from baseline Caregiver Strain Index (CSI) at 12 months
Functional outcome of stroke patients
Changes in level of function of stroke patients over time using the Functional Independence Measure (FIM)
Measured: Change from baseline Functional Independence Measure (FIM) at 12months
Community reintegration of stroke patients
Determining whether patient was reintegrated into community
Measured: At 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2014
- Primary completion30 Apr 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Farayi Kaseke, University of Zimbabwe
- Investigators
- Farayi Kaseke, Masters, Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569099
- Sponsor's protocol ID
- UZimbabwe
- Other IDs
- ID43TWOO9539-03
- Status last verified
- May 2017
- First submitted
- 27 May 2015
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: through publication of results and conference presentations.
Publications
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.
PubMed 34813082
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02569099
- Acronym / sponsor ID
- UZimbabwe
- Conditions
- Stroke
- Keywords
- stroke survivors, caregivers, burden of care, quality of life, function, community reintegration, caregiver training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2014
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SUMMARY
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 family caregivers in Harare and Chitungwiza.
RESEARCH QUESTION 1. What are the effects of a standardised care plus conventional care versus conventional care only on the outcomes of stroke survivors and family caregivers in Harare and Chitungwiza?
RATIONALE FOR RESEARCH
Randomising the participants (people that have survived a stroke and their family caregivers) into trained and untrained groups and following them up using standardised measurement tools will highlight the effect that training has on the quality of life of the stroke survivors and their caregivers as well as function and community reintegration of survivors and burden of care among the caregivers. It is expected this will provide evidence for the need to provide an intervention program that will support family caregivers and improve the outcomes of both. It is against this background that this study aims to determine the effect that a standardised caregiver training program has on the outcomes and quality of life of the caregivers and stroke survivors in Harare and Chitungwiza.
Objectives of the research
Broad Objective
1.To determine the effect of standardized care plus conventional care versus conventional care only on the outcomes of stroke survivors (HIV= and HIV-) and family caregivers over a 12 month period.
Specific Objectives
The objectives of the study were to compare the following in the two arms of the study over a 12 months period:
- quality of life of caregivers
- caregiver burden among caregivers
- functional levels of patients
- quality of life of stroke survivors
- community reintegration among stroke survivors.
- effect of the patient's HIV status on the outcomes of family caregivers.
- effect of the HIV status on the outcomes of stroke survivors.
METHODS This will be a prospective study where the researcher will recruit first ever sufferers of stroke and their family caregivers through hospitals in Harare and Chitungwiza, Zimbabwe. A baseline survey to describe the characteristics of stroke patients and the caregivers will be done at 2 to 14 days post stroke. Medical information about the patients will be taken from their medical records.
A standardized curriculum to train the primary caregivers of stroke patients has been developed using the Kern's six step approach to curriculum development for medical education and will be tested.
The outcomes of the stroke survivors and the family caregivers will then be compared in a randomized control trial with a conventional group to establish any differences.
Participants will be consecutively recruited and randomly allocated into the arm of study using computer generated random numbers. People who have suffered a stroke and admitted in the wards are identified through wards registers. Informed consent and assent for patients who cannot communicate will be sought. Baseline assessment on function and health related quality of life will be done at least 48 hours post stroke for patients. The caregivers who will most likely look after patients will be identified and after giving consent will be assessed on baseline caregiver burden and health related quality of life at recruitment. Research assistants who are trained will be blinded to the arm to which the patients and their caregivers belong. Another research assistant will allocate the participants into the intervention or control arms of the study and communicate with the caregivers for training appointments and the PI who will do all the training for intra-rater reliability.The caregivers are trained on caring for people who have survived a stroke before they are discharged home. The training will include both theoretical input and practical demonstrations. Handouts will be given for their reference later on. training will occur only once. Both the caregiver and patient are then followed up at three months and twelve months. The functional outcomes, quality of life and physical and social reintegration will be elicited from the patients while caregivers will be asked about caregiver burden and quality of life.
RISKS/BENEFITS TO SUBJECTS There will be no risks to the participants for taking part in the study. They would however benefit indirectly by providing useful information to the physiotherapy profession and thus enhance services delivered to them and others affected by stroke.
COST AND COMPENSATION INFORMED CONSENT The participants will not be required to pay anything and neither will they be compensated for taking part in the study.
INFORMED CONSENT Before taking part in the study, participants will be required to read, understand and sign the informed consent which is in Appendix C of the proposal.
CONFIDENTIALITY ASSURANCES The information provided by the participants and their names will not be divulged to anyone. The participants' names or any form of identification will not be required in the questionnaire. The completed questionnaires will be kept securely. The final report may include quotations from the questionnaire but they will be anonymous.
CONFLICT OF INTEREST There are no gains anticipated for carrying out this study except normal scholarly gains for which this study is being carried out.
COLLABORATIVE AGREEMENTS Letters of approval to conduct the study at the study settings are attached.
INTENDED RESULTS The results of the study will be used for purely academic purposes for the fulfillment of a Doctor of Philosophy (DPhil) in physiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention using standardised care | Experimental | Other: Caregiver trainingCaregiver 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver trainingOne hour training of family caregivers on the basic function of the brain and the stroke condition and its management in the home. | Other | Intervention using standardised care |
Primary outcome
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)
3 secondary outcomes
burden of care of family caregivers
Time frame: Change from baseline Caregiver Strain Index (CSI) at 12 months
Functional outcome of stroke patients
Time frame: Change from baseline Functional Independence Measure (FIM) at 12months
Community reintegration of stroke patients
Time frame: At 3 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Derived from this study: PubMed 34813082Crocker 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.
- Individual participant dataSharing planned: Yes. through publication of results and conference presentations.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farayi Kaseke, Masters principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver training in people with Stroke, run by University of Zimbabwe at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02569099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.