Stroke
Conditions
Keywords
stroke, rehabilitation, home care services, effectiveness, quantitative research, interdisciplinary, cost, health services research, integrated
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.
Interventions
OTHERInterprofessional 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.
Sponsors
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
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (pre-randomization) and 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Reintegration to Normal Living Index | Baseline (pre-randomization) and 12 months | 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. | Baseline (pre-randomization) and 12 months | 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. |
| Stroke Impact Scale - 16 | Baseline (pre-randomization) and 12 months | 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. |
| Personal Resource Questionnaire (PRQ85-Part Two) | Baseline (pre-randomization) and 12 months | 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 | Baseline (pre-randomization) and 12 months | 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. |
| Centre for Epidemiological Studies in Depression Scale (CES-D) | Baseline and 12 months | 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). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interprofessional Team Approach Participants in the experimental 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. | 52 |
| 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. | 49 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 3 |
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | Usual Home Care Services | Interprofessional Team Approach | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 42 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 10 Participants | 23 Participants |
| Age, Continuous | 72.32 years STANDARD_DEVIATION 14.14 | 76.18 years STANDARD_DEVIATION 12.35 | 74.31 years STANDARD_DEVIATION 13.33 |
| Region of Enrollment Canada | 49 participants | 52 participants | 101 participants |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 49 |
| serious Total, serious adverse events | 0 / 52 | 0 / 49 |
Outcome results
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.
Time frame: Baseline (pre-randomization) and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interprofessional Team Approach | 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 | 28.84 Units on a scale | Standard Deviation 30.68 |
| Usual Home Care Services | 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 | 28.85 Units on a scale | Standard Deviation 28.48 |
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).
Time frame: Baseline and 12 months
Population: Timepoint 2 minus Timepoint 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interprofessional Team Approach | Centre for Epidemiological Studies in Depression Scale (CES-D) | -2.77 units on a scale | Standard Deviation 9.52 |
| Usual Home Care Services | Centre for Epidemiological Studies in Depression Scale (CES-D) | -2.13 units on a scale | Standard Deviation 9.34 |
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.
Time frame: Baseline (pre-randomization) and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interprofessional Team Approach | Kessler - 10 | -1.66 units on a scale | Standard Deviation 4.79 |
| Usual Home Care Services | Kessler - 10 | -0.46 units on a scale | Standard Deviation 5.3 |
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.
Time frame: Baseline (pre-randomization) and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interprofessional Team Approach | Personal Resource Questionnaire (PRQ85-Part Two) | 4.5 units on a scale | Standard Deviation 14.09 |
| Usual Home Care Services | Personal Resource Questionnaire (PRQ85-Part Two) | 1.01 units on a scale | Standard Deviation 17.74 |
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.
Time frame: Baseline (pre-randomization) and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interprofessional Team Approach | Reintegration to Normal Living Index | 14.84 units on a scale | Standard Deviation 5.71 |
| Usual Home Care Services | Reintegration to Normal Living Index | 15.44 units on a scale | Standard Deviation 5.29 |
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.
Time frame: Baseline (pre-randomization) and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interprofessional Team Approach | Short Portable Mental Status Questionnaire. | 0.38 units on a scale | Standard Deviation 2.17 |
| Usual Home Care Services | Short Portable Mental Status Questionnaire. | 0.67 units on a scale | Standard Deviation 1.38 |
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.
Time frame: Baseline (pre-randomization) and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interprofessional Team Approach | Stroke Impact Scale - 16 | -2.11 units on a scale | Standard Deviation 16.65 |
| Usual Home Care Services | Stroke Impact Scale - 16 | -0.49 units on a scale | Standard Deviation 18.81 |