Clinical trial NCT00958607: Optimizing Stroke Family Caregiver Support Across the Care Continuum by Improving the Timing of Intervention Delivery
Official title: Optimizing Stroke Family Caregiver Support Across the Care Continuum by Improving the Timing of Intervention Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Caregiver Social Support
Caregiver Mental Health
Caregiver Sense of Control Over Life
Caregiver Participation
Keywords: Caregivers
Stroke
Social support
Phase specific care
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: University Health Network, Toronto
name: Foothills Medical Centre
name: Pembroke Regional Hospital
name: South Shore District Health Authority
name: Champlain Region Sroke Centre
name: University of Ottawa
name: Dalhousie University
name: Canadian Stroke Strategy
name: Toronto Rehabilitation Institute
First posted: 2009-08-13
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

1. Assess whether the intervention improves caregivers outcomes (via quantitative analysis)
2. Assess how the intervention improves caregiver outcomes (via qualitative analysis)
3. Assess how the intervention is delivered (via stroke support person journals)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Caregivers of terminally ill stroke survivors or of survivors discharged to complex continuing care, long-term care or assisted retirement residences.

Primary outcomes:
measure: The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale.
timeFrame: Baseline, 3, 6 and 12-months post-stroke
Secondary outcomes:
measure: 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
timeFrame: Baseline, 3, 6 and 12-months post-stroke
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto -- Dpt. of Occupational Science and Occupational Therapy
state: Ontario
Study officials:
affiliation: University of Toronto
name: Jill Cameron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Cameron 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.