StrokeNCT00958607
Optimizing Stroke Family Caregiver Support Across the Care Continuum by Improving the Timing of Intervention Delivery
A study testing Timing it Right Stroke Family Support Person Intervention and Self-directed program in people with Stroke and Caregiver Social Support, run by University of Toronto at 1 site in Canada.
Trial summary
About 50% of stroke survivors have limitations in their activities of daily living on return to the community. Family caregivers provide invaluable support to these individuals during their recovery and rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Caregiver Social Support, Caregiver Mental Health
- What is being tested?
- Timing it Right Stroke Family Support Person Intervention and Self-directed program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must speak and read English and be the primary family caregiver of a person who is receiving care for their first hospitalization for an ischemic or hemorrhagic stroke and whose anticipated ultimate destination after discharge is a private residence or apartment building.
- Stroke survivors must exhibit at least minimal disability (i.e., are referred to at least one rehabilitation health care professional during acute care). They may be admitted to short or long-duration inpatient (maximum duration of 6 months) or outpatient rehabilitation or return directly home.
Who cannot join
- Caregivers of terminally ill stroke survivors or of survivors discharged to complex continuing care, long-term care or assisted retirement residences.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto -- Dpt. of Occupational Science and Occupational Therapy
Toronto, Ontario, M5G 1V7
About this study
About 50% of stroke survivors have limitations in their activities of daily living on return to the community. Family caregivers provide invaluable support to these individuals during their recovery and rehabilitation. Unfortunately, there is no standard clinical practice to prepare caregivers for this role and, as a result, many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of the care needed to thrive in their home. To address this gap, the investigators have developed the Timing it Right Stroke Family Support Program that aims to meet the evolving needs of caregivers. The objective of this multi-province randomized controlled trial is to determine if this program delivered across the stroke care continuum improves caregivers' sense of being supported and emotional well-being. Ultimately this program could be used by stroke care programs from across Canada.
Read the detailed description
The objective of this multi-province randomized controlled trial will be to determine if the TIR Stroke Family Support Program delivered across the care continuum contributes to positive caregiver outcomes. Since this program targets family caregiver support, the primary outcomes of the intervention will be caregivers' perception of being supported in their care-giving role and improvements in caregiver mental health outcomes (e.g., less depression and more psychological well-being). To determine the impact of the intervention on caregiver outcomes, we will compare two modes of intervention delivery with standard care: 1) repeated contact in person and by telephone with a stroke support person and 2) a self-directed program by the caregiver.
We will perform a multi-site, mixed methods RCT. Caregivers of patients who are receiving acute care for their first stroke will be recruited within the first week of hospital admission. Members of the stroke team from the participating hospitals' stroke units will identify potential participants and ask their permission to be approached by each site's research assistant. The research assistant will fully explain the study, answer questions, obtain consent, administer the baseline questionnaires, and then contact the project coordinator who will then randomize participants to one of three groups: A) TIR Stroke Family Support Program delivered by a stroke support person, B) caregiver self-directed TIR Stroke Family Support Program, and C) usual care that includes provision of the Heart and Stroke educational resource "Let's Talk about Stroke". The research assistants will give caregivers a copy of "Let's Talk about Stroke" (if they have not yet received a copy) and introduce them to the stroke support person who will deliver the full intervention and instruct the family in the use of the self-directed arm of the intervention. A second part-time research assistant blinded to group assignment will complete routine follow-up assessments with participants at 3, 6, and 12 months post-stroke. A subset of 36 participants (6 from each site) will also participate in a qualitative interview after completion of their 12-month follow-up assessment.
The goals of this multi-site randomized controlled trial are to:
- Assess whether the intervention improves caregivers outcomes (via quantitative analysis)
- Assess how the intervention improves caregiver outcomes (via qualitative analysis)
- Assess how the intervention is delivered (via stroke support person journals)
- Conditions
- Stroke, Caregiver Social Support, Caregiver Mental Health, Caregiver Sense of Control Over Life, Caregiver Participation
- Being tested
- Timing it Right Stroke Family Support Person Intervention, Self-directed program
- Keywords
- Caregivers, Stroke, Social support, Phase specific care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing it Right Stroke Family Support Person InterventionBehavioural
Intervention delivered by a stroke support person (SSP) in-person during acute care \& by telephone during inpatient rehabilitation and community discharge. SSP provides support, information \& guidance and gives caregivers Stroke Family Support guide as a resource. SSP will have 1 contact with the caregiver during acute care and a 2nd contact during the last week of inpatient acute or rehabilitation care. The 1st contact while the caregiver is at home will occur 2-3 weeks after the stroke survivor has been discharged from inpatient care and then every four weeks until the caregiver passes the marker question. SSP will then encourage caregiver to contact them if they have any specific questions. The SSP will make one final contact about 8 weeks later
Self-directed programBehavioural
Participants in this arm of the trial will have family caregivers self-direct their use of the Timing it Right Stroke Family Support guide. The research assistant will instruct the caregivers how to self-manage their support needs by providing instruction on how to use the guide, which has an additional section regarding self-management. Caregivers will also be instructed that the guide is organized according to the phases of a stroke survivors' recovery. They will be instructed to review the information in each chapter as it becomes relevant to their current situation
| Study group | Role | What they receive |
|---|---|---|
| Self-Directed Program | Active comparator | Not described Receives: Behavioral: Self-directed program |
| Stroke Support Person | Active comparator | Not described Receives: Behavioral: Timing it Right Stroke Family Support Person Intervention |
| Standard Care | No intervention | Participants in this arm receive Standard Care which consists of being given a copy of the Heart\& Stroke Foundation's stroke resource titled "Let's Talk About Stroke" |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale.
Measured: Baseline, 3, 6 and 12-months post-stroke
Secondary outcomes (1)
Positive/negative mental health outcomes will be assessed by the Positive Affect Scale and Centre for Epidemiological Studies Depression Scale, respectively. Caregivers' participation in valued activities will be assessed by the Caregiving Impact Scale
Measured: Baseline, 3, 6 and 12-months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, University Health Network, Toronto, Foothills Medical Centre, Pembroke Regional Hospital, South Shore District Health Authority, Champlain Region Sroke Centre, University of Ottawa, Dalhousie University, Canadian Stroke Strategy, Toronto Rehabilitation Institute
- Responsible party
- Principal investigator, Jill Cameron, University of Toronto
- Investigators
- Jill Cameron, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958607
- Sponsor's protocol ID
- 212054-487481
- Status last verified
- Jan 2014
- First submitted
- 12 Aug 2009
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cameron JI, Gignac MA. "Timing It Right": a conceptual framework for addressing the support needs of family caregivers to stroke survivors from the hospital to the home. Patient Educ Couns. 2008 Mar;70(3):305-14. doi: 10.1016/j.pec.2007.10.020. Epub 2007 Dec 21.
PubMed 18155388Crocker 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 34813082Cameron JI, Naglie G, Gignac MA, Bayley M, Warner G, Green T, Czerwonka A, Huijbregts M, Silver FL, Phillips SJ, Cheung AM. Randomized clinical trial of the Timing it Right Stroke Family Support Program: research protocol. BMC Health Serv Res. 2014 Jan 17;14:18. doi: 10.1186/1472-6963-14-18.
PubMed 24433234
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Stroke Family Caregiver Support Across the Care Continuum by Improving the Timing of Intervention Delivery
- ClinicalTrials.gov ID
- NCT00958607
- Acronym / sponsor ID
- 212054-487481
- Conditions
- Stroke, Caregiver Social Support, Caregiver Mental Health, Caregiver Sense of Control Over Life, Caregiver Participation
- Keywords
- Caregivers, Stroke, Social support, Phase specific care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, University Health Network, Toronto, Foothills Medical Centre, Pembroke Regional Hospital, South Shore District Health Authority, Champlain Region Sroke Centre, University of Ottawa, Dalhousie University, Canadian Stroke Strategy, Toronto Rehabilitation Institute
- Study start
- Sep 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Aug 2009 (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.
About 50% of stroke survivors have limitations in their activities of daily living on return to the community. Family caregivers provide invaluable support to these individuals during their recovery and rehabilitation. Unfortunately, there is no standard clinical practice to prepare caregivers for this role and, as a result, many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of the care needed to thrive in their home. To address this gap, the investigators have developed the Timing it Right Stroke Family Support Program that aims to meet the evolving needs of caregivers. The objective of this multi-province randomized controlled trial is to determine if this program delivered across the stroke care continuum improves caregivers' sense of being supported and emotional well-being. Ultimately this program could be used by stroke care programs from across Canada.
Detailed description
The objective of this multi-province randomized controlled trial will be to determine if the TIR Stroke Family Support Program delivered across the care continuum contributes to positive caregiver outcomes. Since this program targets family caregiver support, the primary outcomes of the intervention will be caregivers' perception of being supported in their care-giving role and improvements in caregiver mental health outcomes (e.g., less depression and more psychological well-being). To determine the impact of the intervention on caregiver outcomes, we will compare two modes of intervention delivery with standard care: 1) repeated contact in person and by telephone with a stroke support person and 2) a self-directed program by the caregiver.
We will perform a multi-site, mixed methods RCT. Caregivers of patients who are receiving acute care for their first stroke will be recruited within the first week of hospital admission. Members of the stroke team from the participating hospitals' stroke units will identify potential participants and ask their permission to be approached by each site's research assistant. The research assistant will fully explain the study, answer questions, obtain consent, administer the baseline questionnaires, and then contact the project coordinator who will then randomize participants to one of three groups: A) TIR Stroke Family Support Program delivered by a stroke support person, B) caregiver self-directed TIR Stroke Family Support Program, and C) usual care that includes provision of the Heart and Stroke educational resource "Let's Talk about Stroke". The research assistants will give caregivers a copy of "Let's Talk about Stroke" (if they have not yet received a copy) and introduce them to the stroke support person who will deliver the full intervention and instruct the family in the use of the self-directed arm of the intervention. A second part-time research assistant blinded to group assignment will complete routine follow-up assessments with participants at 3, 6, and 12 months post-stroke. A subset of 36 participants (6 from each site) will also participate in a qualitative interview after completion of their 12-month follow-up assessment.
The goals of this multi-site randomized controlled trial are to:
- Assess whether the intervention improves caregivers outcomes (via quantitative analysis)
- Assess how the intervention improves caregiver outcomes (via qualitative analysis)
- Assess how the intervention is delivered (via stroke support person journals)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-Directed Program | Active comparator | Behavioral: Self-directed program |
| Stroke Support Person | Active comparator | Behavioral: Timing it Right Stroke Family Support Person Intervention |
| Standard Care | No intervention | –Participants in this arm receive Standard Care which consists of being given a copy of the Heart\& Stroke Foundation's stroke resource titled "Let's Talk About Stroke" |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must speak and read English and be the primary family caregiver of a person who is receiving care for their first hospitalization for an ischemic or hemorrhagic stroke and whose anticipated ultimate destination after discharge is a private residence or apartment building.
- Stroke survivors must exhibit at least minimal disability (i.e., are referred to at least one rehabilitation health care professional during acute care). They may be admitted to short or long-duration inpatient (maximum duration of 6 months) or outpatient rehabilitation or return directly home.
Key exclusion criteria (1 listed)
- Caregivers of terminally ill stroke survivors or of survivors discharged to complex continuing care, long-term care or assisted retirement residences.
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 |
|---|---|---|
| Timing it Right Stroke Family Support Person InterventionIntervention delivered by a stroke support person (SSP) in-person during acute care \& by telephone during inpatient rehabilitation and community discharge. SSP provides support, information \& guidance and gives caregivers Stroke Family Support guide as a resource. SSP will have 1 contact with the caregiver during acute care and a 2nd contact during the last week of inpatient acute or rehabilitation care. The 1st contact while the caregiver is at home will occur 2-3 weeks after the stroke survivor has been discharged from inpatient care and then every four weeks until the caregiver passes the marker question. SSP will then encourage caregiver to contact them if they have any specific questions. The SSP will make one final contact about 8 weeks later | Behavioural | Stroke Support Person |
| Self-directed programParticipants in this arm of the trial will have family caregivers self-direct their use of the Timing it Right Stroke Family Support guide. The research assistant will instruct the caregivers how to self-manage their support needs by providing instruction on how to use the guide, which has an additional section regarding self-management. Caregivers will also be instructed that the guide is organized according to the phases of a stroke survivors' recovery. They will be instructed to review the information in each chapter as it becomes relevant to their current situation | Behavioural | Self-Directed Program |
Primary outcome
The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale.
Time frame: Baseline, 3, 6 and 12-months post-stroke
1 secondary outcome
Positive/negative mental health outcomes will be assessed by the Positive Affect Scale and Centre for Epidemiological Studies Depression Scale, respectively. Caregivers' participation in valued activities will be assessed by the Caregiving Impact Scale
Time frame: Baseline, 3, 6 and 12-months post-stroke
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 22 Jan 2014.
- Background: PubMed 18155388Cameron JI, Gignac MA. "Timing It Right": a conceptual framework for addressing the support needs of family caregivers to stroke survivors from the hospital to the home. Patient Educ Couns. 2008 Mar;70(3):305-14. doi: 10.1016/j.pec.2007.10.020. Epub 2007 Dec 21.
- 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.
- Derived from this study: PubMed 24433234Cameron JI, Naglie G, Gignac MA, Bayley M, Warner G, Green T, Czerwonka A, Huijbregts M, Silver FL, Phillips SJ, Cheung AM. Randomized clinical trial of the Timing it Right Stroke Family Support Program: research protocol. BMC Health Serv Res. 2014 Jan 17;14:18. doi: 10.1186/1472-6963-14-18.
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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.
Jill Cameron, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing it Right Stroke Family Support Person Intervention and Self-directed program in people with Stroke and Caregiver Social Support, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 22 Jan 2014. 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 Canada. 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?
The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale. (time frame: Baseline, 3, 6 and 12-months post-stroke). 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 NCT00958607, which also lists 3 linked publications.
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 22 Jan 2014.