NCT00958607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

4.1 years

First QC Date

August 12, 2009

Last Update Submit

January 20, 2014

Conditions

StrokeCaregiver Social SupportCaregiver Mental HealthCaregiver Sense of Control Over LifeCaregiver Participation

Keywords

CaregiversStrokeSocial supportPhase specific care

Outcome Measures

Primary Outcomes (1)

  • The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale.

    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

    Baseline, 3, 6 and 12-months post-stroke

Study Arms (3)

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"

Interventions

Timing it Right Stroke Family Support Person InterventionBEHAVIORAL

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

Stroke Support Person
Self-directed programBEHAVIORAL

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

Self-Directed Program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto -- Dpt. of Occupational Science and Occupational Therapy

Toronto, Ontario, M5G 1V7, Canada

Location

Related Publications (3)

  • 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.

    PMID: 18155388BACKGROUND

  • 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: 34813082DERIVED

  • 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.

    PMID: 24433234DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jill Cameron, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jill Cameron, PhD

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

CA(1)