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Interdisciplinary Team Approach to Stroke Rehabilitation in Home Care

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interprofessional Team Approach
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, home care services, effectiveness, quantitative research, interdisciplinary, cost, health services research, integrated

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Nursing, McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interprofessional Team Approach

Usual Home Care Services

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Stroke Impact Scale - 16
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 (range from 16 to 80), with higher scores indicating higher levels of health-related quality of life and function.
Reintegration to Normal Living Index
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. Minimum score is "0" and maximum score is "22". The individual items sum to provide a total score, with 22 indicating the highest degree of reintegration.
Short Portable Mental Status Questionnaire.
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, ranging from 0-10; with greater than 4 errors indicating some degree of intellectual impairment. The higher the score, the less impairment.
Centre for Epidemiological Studies in Depression Scale (CES-D)
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. Values were determined by taking the value of the 12-month data (Timepoint 2) and subtracting them from the baseline data (Timepoint 1).
Personal Resource Questionnaire (PRQ85-Part Two)
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. Scores range from a minimum of 25 to maximum score of 175; a higher score indicates a greater perception of social support.
Kessler - 10
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.

Full Information

First Posted
April 18, 2007
Last Updated
November 7, 2018
Sponsor
McMaster University
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
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1. Study Identification

Unique Protocol Identification Number
NCT00463229
Brief Title
Interdisciplinary Team Approach to Stroke Rehabilitation in Home Care
Official Title
The Comparative Acceptability, Safety, Effects and Expense of Specialized, Integrated, and Interdisciplinary Community Rehabilitation for Stroke Survivors and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, home care services, effectiveness, quantitative research, interdisciplinary, cost, health services research, integrated

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interprofessional Team Approach
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Home Care Services
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Interprofessional Team Approach
Other Intervention Name(s)
Interdisciplinary Stroke Rehabilitation Team
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (pre-randomization) and 12 months
Secondary Outcome Measure Information:
Title
Stroke Impact Scale - 16
Description
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 (range from 16 to 80), with higher scores indicating higher levels of health-related quality of life and function.
Time Frame
Baseline (pre-randomization) and 12 months
Title
Reintegration to Normal Living Index
Description
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. Minimum score is "0" and maximum score is "22". The individual items sum to provide a total score, with 22 indicating the highest degree of reintegration.
Time Frame
Baseline (pre-randomization) and 12 months
Title
Short Portable Mental Status Questionnaire.
Description
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, ranging from 0-10; with greater than 4 errors indicating some degree of intellectual impairment. The higher the score, the less impairment.
Time Frame
Baseline (pre-randomization) and 12 months
Title
Centre for Epidemiological Studies in Depression Scale (CES-D)
Description
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. Values were determined by taking the value of the 12-month data (Timepoint 2) and subtracting them from the baseline data (Timepoint 1).
Time Frame
Baseline and 12 months
Title
Personal Resource Questionnaire (PRQ85-Part Two)
Description
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. Scores range from a minimum of 25 to maximum score of 175; a higher score indicates a greater perception of social support.
Time Frame
Baseline (pre-randomization) and 12 months
Title
Kessler - 10
Description
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.
Time Frame
Baseline (pre-randomization) and 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Markle-Reid, RN MScN PhD
Organizational Affiliation
McMaster University, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21320840
Citation
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.
Results Reference
derived

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Interdisciplinary Team Approach to Stroke Rehabilitation in Home Care

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