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Interdisciplinary Team Approach to Stroke Rehabilitation in Home Care

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ontario Ministry of Health and Long Term Care
Toronto Central Community Care Access Centre
Heart and Stroke Foundation of Ontario
Greater Toronto Area Rehabilitation Network
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00463229
First received: April 18, 2007
Last updated: September 28, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Stroke
Other: Interprofessional Team Approach
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Acceptability, Safety, Effects and Expense of Specialized, Integrated, and Interdisciplinary Community Rehabilitation for Stroke Survivors and Their Caregivers

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • SF-36 Physical Function Score to Measure the Change in Health-related Quality of Life and Function From Baseline (Pre-randomization)to 12 Months. [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Stroke Impact Scale - 16 [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    The SIS-16 assesses several aspects of health-related quality of life that are important to stroke survivors, caregivers, and healthcare professionals. The SIS-16 consists of 16 items which cover the physical aspects of stroke including: strength, hand function, mobility, and activities of daily living/instrumental activities of daily living. Each item is assigned a score ranging from 1 (could not do at all) to 5 (not difficult at all). The individual items sum to provide a total score, with higher scores indicating higher levels of health-related quality of life and function.

  • Reintegration to Normal Living Index [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    The RNLI assesses global functional status and measures both the stroke survivors' perceptions of their own capabilities and objective indicators of physical, social, and psychological performance. The RNLI consists of 11 items which cover the domains of mobility, self-care abilities, daily activities, recreational and social activities, family roles, and personal relationships, presentation of self and general coping skills. Each item is scored as 0 to 2. The individual items sum to provide a total score, with 22 indicating the highest degree of reintegration.

  • Short Portable Mental Status Questionnaire. [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    The 10-item Short Portable Mental Status Questionnaire (SPMSQ) is used for the screening, diagnosis and assessment of cognition. The SPMSQ is short, easily administered and has been designed, tested, standardized and validated in a variety of populations, including stroke. The SPMSQ consists of 10 items. The individual items sum to provide a total score; with greater than 4 errors indicating some degree of intellectual impairment.

  • Centre for Epidemiological Studies in Depression Scale (CES-D) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    The CES-D scale is a 20-item, self-reported questionnaire that assesses the current frequency of depressive symptoms. Total scores can range from 0 to 60; the higher the score, the more depressed.

  • Caregiver Reaction Assessment Scale. [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    The Caregiver Reaction Assessment Scale is a multidimensional, 5-factor measure designed to assess the negative and positive aspects of caregiving. Each item is scored from 1 to 5 from strongly disagree to strongly agree. There are five subscales: (a) esteem, (b) family support, (c) finances, (d) impact on schedule, and (e) impact on health.

  • Personal Resource Questionnaire (PRQ85-Part Two) [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    The PRQ85-Part Two is a 25-item scale that measures perceived social support along five dimensions: provision for attachment/intimacy; social integration; opportunity for nurturing behaviour; reassurance of worth as an individual and in role accomplishments; and the availability of informational, emotional, and material help. The maximum score is 175; a higher score indicates a greater perception of social support.

  • Health and Social Services Utilization Inventory [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    The costs of use of all types of health services from baseline to 12 months were determined using the Health and Social Services Utilization Inventory (HSSUI), which assesses costs from a societal perspective. The HSSUI consists of questions about the respondent's use of six categories of direct health care services: (1) primary care; (2) emergency department and specialists; (3) hospital days; (4) seven types of other health and social professionals; (5) medications; and (6) lab services. The product of the number of units of service (quantity) and unit cost (price) is total cost.

  • Kessler - 10 [ Time Frame: Baseline (pre-randomization) and 12 months ] [ Designated as safety issue: No ]
    The Kessler-10 assesses level of anxiety and depressive symptoms a person may have experienced in the most recent four-week period. Its main strength is a superior ability to screen for anxiety and affective disorders. Each item is assigned a score ranging from 5 (all of the time) to 1 (none of the time). These 10 items are summed to give scores ranging from 10-50, where 50 indicates high risk of anxiety or depressive disorder. Previous studies have established a cut-off score of 16-29/50 for medium risk, and 30-50/50 as high risk for anxiety and depressive disorders.


Enrollment: 101
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interprofessional Team Approach
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
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.
Other Name: Interdisciplinary Stroke Rehabilitation Team
No Intervention: Usual Home Care Services
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.

Detailed Description:

Stroke is the third leading cause of death in Canada, and is considered to be the most common disabling chronic condition. Approximately 40,000 to 50,000 people in Canada experience a stroke each year and about 80% of these people survive. Many of these people who survive a stroke never fully recover and are left with significant impairments and disabilities, and 12% to 25% will have another stroke within the first year. This results in a significant burden to individuals, families, and society as a whole. Of every 100 people who are hospitalized for a stroke, 15-40 return home and require home care services for rehabilitation. Stroke rehabilitation is one of the key components of stroke care. The goal of rehabilitation is to assist stroke survivors to reach his or her optimal level of physical, social, and emotional function.

Information gained from this study will be used to inform home care practice, policy decisions and the allocation of home care resources and make a national contribution to health care delivery reform.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463229

Locations
Canada, Ontario
School of Nursing, McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Ontario Ministry of Health and Long Term Care
Toronto Central Community Care Access Centre
Heart and Stroke Foundation of Ontario
Greater Toronto Area Rehabilitation Network
Investigators
Principal Investigator: Maureen Markle-Reid, RN MScN PhD McMaster University - School of Nursing
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ms. Marie Townsend, Committee on Scientific Development, McMaster University
ClinicalTrials.gov Identifier: NCT00463229     History of Changes
Other Study ID Numbers: PHE-78692
Study First Received: April 18, 2007
Results First Received: July 22, 2010
Last Updated: September 28, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
stroke
rehabilitation
home care services
effectiveness
quantitative research
interdisciplinary
cost
health services research, integrated

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014