Interdisciplinary Team Approach to Stroke Rehabilitation in Home Care

Stroke Clinical Trial

Official title:

The Comparative Acceptability, Safety, Effects and Expense of Specialized, Integrated, and Interdisciplinary Community Rehabilitation for Stroke Survivors and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463229
• Other study ID #: PHE-78692
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: November 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	School of Nursing, McMaster University	Hamilton	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Greater Toronto Area Rehabilitation Network, Heart and Stroke Foundation of Ontario, Ontario Ministry of Health and Long Term Care, Toronto Central Community Care Access Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (pre-randomization) and 12 months
Secondary	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.	Baseline (pre-randomization) and 12 months
Secondary	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.	Baseline (pre-randomization) and 12 months
Secondary	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).	Baseline and 12 months
Secondary	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.	Baseline (pre-randomization) and 12 months
Secondary	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.	Baseline (pre-randomization) and 12 months