NCT00463229

Brief Summary

As the population ages and the number of stroke survivors increases, information is needed to determine the best way of providing home care services for rehabilitation to stroke survivors and their caregivers while containing health care costs. This project will address this area by developing and testing the effects and costs of a collaborative and specialized team approach to stroke rehabilitation by health professionals, in a home care setting, compared to usual home care services. The overall goal of this way of providing home care services is to improve the quality of life and function of stroke survivors and their caregivers and prevent future strokes, which will reduce the overall cost to the health care system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2006

Typical duration 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

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 15, 2010

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

2.6 years

First QC Date

April 18, 2007

Results QC Date

July 22, 2010

Last Update Submit

November 7, 2018

Conditions

Keywords

strokerehabilitationhome care serviceseffectivenessquantitative researchinterdisciplinarycosthealth services research, integrated

Outcome Measures

Primary Outcomes (1)

  • Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function

    The primary measure of effect was the change in health-related quality of life and functioning from baseline to 12-months as measured by the SF-36 physical functioning score. The range of possible scores for this subscale is 0-100, with a higher score indicating a more favourable health status.

    Baseline (pre-randomization) and 12 months

Secondary Outcomes (6)

  • Stroke Impact Scale - 16

    Baseline (pre-randomization) and 12 months

  • Reintegration to Normal Living Index

    Baseline (pre-randomization) and 12 months

  • Short Portable Mental Status Questionnaire.

    Baseline (pre-randomization) and 12 months

  • Centre for Epidemiological Studies in Depression Scale (CES-D)

    Baseline and 12 months

  • Personal Resource Questionnaire (PRQ85-Part Two)

    Baseline (pre-randomization) and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Interprofessional Team Approach

EXPERIMENTAL

Participants in the experimental group will receive home care services from a team of professional service providers \[Community Care Access Centre (CCAC) Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist\] and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.

Other: Interprofessional Team Approach

Usual Home Care Services

NO INTERVENTION

Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.

Interventions

Subject in the second group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.

Also known as: Interdisciplinary Stroke Rehabilitation Team
Interprofessional Team Approach

Eligibility Criteria

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

You may qualify if:

  • diagnosis of stroke or TIA has been confirmed.
  • newly referred to and eligible for home care services (physiotherapy, speech language therapy, occupational therapy, nursing) through the Toronto Central CCAC.
  • living at home in the community (outside of an institutional setting) up to 18-months post-stroke.
  • English speaking

You may not qualify if:

  • refuse to give informed consent.
  • more than 18 months post-stroke at time of recruitment.
  • unable to read/write English and an appropriate translator is not available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

  • Markle-Reid M, Orridge C, Weir R, Browne G, Gafni A, Lewis M, Walsh M, Levy C, Daub S, Brien H, Roberts J, Thabane L. Interprofessional stroke rehabilitation for stroke survivors using home care. Can J Neurol Sci. 2011 Mar;38(2):317-34. doi: 10.1017/s0317167100011537.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Maureen Markle-Reid
Organization
McMaster University

Study Officials

  • Maureen Markle-Reid, RN MScN PhD

    McMaster University, School of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

February 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 4, 2018

Results First Posted

October 15, 2010

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations