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Optimizing Stroke Family Caregiver Support Across the Care Continuum by Improving the Timing of Intervention Delivery

20 januari 2014 bijgewerkt door: Jill Cameron, University of Toronto
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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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)

Studietype

Ingrijpend

Inschrijving (Werkelijk)

310

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1V7
        • University of Toronto -- Dpt. of Occupational Science and Occupational Therapy

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Self-Directed Program
Gedragsmatig: Self-directed program
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
Actieve vergelijker: Stroke Support Person
Gedragsmatig: Timing it Right Stroke Family Support Person Intervention
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
Geen tussenkomst: Standard Care
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"

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale.
Tijdsspanne: Baseline, 3, 6 and 12-months post-stroke
Baseline, 3, 6 and 12-months post-stroke

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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
Tijdsspanne: Baseline, 3, 6 and 12-months post-stroke
Baseline, 3, 6 and 12-months post-stroke

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Toronto

Medewerkers

University Health Network, Toronto
University of Ottawa
Dalhousie University
Toronto Rehabilitation Institute
Heart and Stroke Foundation of Canada
Foothills Medical Centre
Pembroke Regional Hospital
South Shore District Health Authority
Champlain Region Sroke Centre
Canadian Stroke Strategy

Onderzoekers

  • Hoofdonderzoeker: Jill Cameron, PhD, University of Toronto

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2009

Primaire voltooiing (Werkelijk)

1 oktober 2013

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

12 augustus 2009

Eerst ingediend dat voldeed aan de QC-criteria

12 augustus 2009

Eerst geplaatst (Schatting)

13 augustus 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

22 januari 2014

Laatste update ingediend die voldeed aan QC-criteria

20 januari 2014

Laatst geverifieerd

1 januari 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 212054-487481

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