Stroke
Conditions
Keywords
Stroke, Self-Management, Transient ischemic attack, Self-Efficacy
Brief summary
The experience of a stroke event may result in a disruption to the survivor's daily life. Patients with stroke have reported fears of permanent disability and major concerns over their ability to recover and be productive and engaged with family, friends and coworkers. To enhance recovery from stroke, the investigators designed a stroke self-management program and have pilot tested the program among Veterans recovering from stroke/TIA. The study is a three-site, randomized controlled trial designed to test the efficacy of a stroke self-management program. The intervention program includes 6 bi-weekly sessions over months 1-3 followed by monthly telephone calls as the investigators administered in the investigators' pilot study during months 4-6 for a total length of program duration of 6 months. The investigators have added 3 monthly group support sessions during months 4-6 for additional peer support. Thus, participants will receive bi-monthly support during months 4-6. The three intervention sites include the Jesse Brown VAMC in Chicago, the Roudebush VAMC in Indianapolis, and the IU Health Methodist Hospital in Indianapolis, Indiana. The three hospitals represent facilities with a small, moderate, and large volume of acute stroke care, respectively. Additionally, Methodist Hospital includes a greater proportion of women which enables us to study the patterns and preferences of women with stroke/TIA and tailor the investigators' future programs to prepare for the increasing female Veteran population.
Detailed description
Stroke Self-Management: Effect on Function and Stroke Quality of Life Anticipated Impacts on Participant's Healthcare: This planned evaluation of the investigators' stroke self-management program may improve the patient's healthcare by establishing an evidence-based program for which VA case managers may implement to improve patient self-management and the health-related quality of life of stroke survivors. This program produced standardized manuals for case managers and stroke survivors that may be used in the field, in the patient medical care home and via telehealth. Project Background: Stroke is prevalent and associated with increased morbidity and mortality. Stroke is the leading cause of long-term disability in the US. Within the VA, approximately 60,000 patients had a primary outpatient encounter for stroke during fiscal year 2010 (FY10). Data from the Office of Quality and Performance (OQP) Stroke Special Study demonstrate that more than 5,000 Veterans were admitted to a VA facility for acute ischemic stroke in FY07 and another 5000 Veterans with a transient ischemic attack (TIA) or mini-stroke, were admitted in a VA facility or received care at an urgent clinic or emergency department in VA. The total VA cost of stroke treatment was almost $315 million in FY05, with a cost per patient of over $18,000. Stroke/TIA survivors are at elevated risk for future vascular events and yet, there are no systematic post stroke programs offered widely in VA designed to reduce this risk and increase stroke specific quality of life in Veterans. The investigators recently developed and pilot tested a stroke self-management program that adapted the Stanford Chronic Disease program for stroke. Project Objectives: The objectives of this project were to: 1. Conduct a randomized trial comparing stroke survivors randomly assigned to receive a stroke self-management program on patient functioning, stroke self-management, and stroke specific quality of life compared to stroke survivors assigned to usual care; and 2. Conduct a summative evaluation among VA clinical providers, patients with stroke and their caregivers to understand the barriers and facilitators of implementing the stroke self-management program. Project Methods: To accomplish these aims, the investigators employed mixed methods. For the first aim, the investigators conducted a randomized controlled trial comparing subjects randomly assigned to the stroke self-management intervention to subjects randomly assigned to usual care. Subjects from both groups were assessed at baseline, 3, 6, and 12 months. We delivered the stroke self-management program over 6 months (12 weeks biweekly sessions followed by 12 weeks of bimonthly telephone and group support sessions). Usual care participants received written stroke risk factor materials. The primary outcomes were stroke specific quality of life and the secondary outcomes were stroke self-management, self-efficacy, functioning, and post stroke depression. We are evaluating clinical risk factor management after stroke.
Interventions
BEHAVIORALStroke Self-Management
Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient eligibility criteria include: * age 18 or older; * acute diagnosis of ischemic stroke or TIA within past 12 months; * able to speak and understand English; * no severe cognitive impairment; * access to a telephone; * willing to follow-up in VA/IU Health outpatient care; * had a previous outpatient primary care visit during the past 12 months in VA/IU Health outpatient care; * willing to attend all individual phone and group meetings during the 6 month intervention; and * life expectancy of at least 6 months as defined by the patient's neurologist at stroke event.
Exclusion criteria
* Short Portable Mental Status score \< 7; * Significant language comprehension (NIH Stroke Scale commands score \> 0); or * Receptive language deficits (NIH Stroke Scale aphasia score \> 2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Stroke Specific Quality of Life | Change from baseline to 6 months | A 49-item instrument that assesses 12 domains relevant to stroke patients' health-related quality of life including: energy, mobility, work, upper extremity function, activities of daily living, family roles, social roles, vision, language, thinking, mood, and personality. A lower score indicates poorer functioning and a higher score indicates better functioning. The minimum value was 1 and maximum value was 5. A Total Stroke Specific Quality of Life Score was calculated as the mean of the 49-items. |
Countries
United States
Participant flow
Recruitment details
Recruitment period ran from Jan 7, 2013 through March 31, 2016. Recruitment sites included 2 Veterans Health Administration Medical Facilities, 1 Joint Commission Stroke Center in an urban Hospital, and 1 Safety Net Urban Hospital.
Participants by arm
| Arm | Count |
|---|---|
| SSM Intervention Arm 1 Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.
Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6. | 129 |
| Usual Care Arm 2 Usual care which includes standardized patient education materials on stroke from the American Stroke Association. | 129 |
| Total | 258 |
Baseline characteristics
| Characteristic | SSM Intervention Arm 1 | Usual Care Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 61.09 years STANDARD_DEVIATION 10.77 | 62.41 years STANDARD_DEVIATION 10.87 | 61.75 years STANDARD_DEVIATION 10.82 |
| Cerebrovascular Events Stroke | 109 Participants | 109 Participants | 218 Participants |
| Cerebrovascular Events Transient Ischemic Attack (TIA) | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 127 Participants | 254 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Length of time (days) | 85.74 Days | 77.20 Days | 81.47 Days |
| National Institute on Health Stroke Scale (NIHSS) | 3.00 units on a scale STANDARD_DEVIATION 3.2 | 2.96 units on a scale STANDARD_DEVIATION 2.81 | 2.98 units on a scale STANDARD_DEVIATION 3.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 32 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 77 Participants | 89 Participants | 166 Participants |
| Region of Enrollment United States | 129 Participants | 129 Participants | 258 Participants |
| Self-Efficacy to Manage Stroke Symptoms | 8.27 units on a scale STANDARD_DEVIATION 1.72 | 8.47 units on a scale STANDARD_DEVIATION 1.55 | 8.37 units on a scale STANDARD_DEVIATION 1.64 |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Male | 106 Participants | 103 Participants | 209 Participants |
| Stroke Specific Quality of Life | 3.06 units on a scale STANDARD_DEVIATION 0.76 | 3.16 units on a scale STANDARD_DEVIATION 0.73 | 3.11 units on a scale STANDARD_DEVIATION 0.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 129 | 2 / 129 |
| other Total, other adverse events | 72 / 129 | 61 / 129 |
| serious Total, serious adverse events | 44 / 129 | 35 / 129 |
Outcome results
Primary
Total Stroke Specific Quality of Life
A 49-item instrument that assesses 12 domains relevant to stroke patients' health-related quality of life including: energy, mobility, work, upper extremity function, activities of daily living, family roles, social roles, vision, language, thinking, mood, and personality. A lower score indicates poorer functioning and a higher score indicates better functioning. The minimum value was 1 and maximum value was 5. A Total Stroke Specific Quality of Life Score was calculated as the mean of the 49-items.
Time frame: Change from baseline to 6 months
Population: Participants were patients discharged with an acute stroke or TIA as the primary diagnoses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 SSM Intervention | Total Stroke Specific Quality of Life | 12 months outcome | 4.02 units on a scale | Standard Deviation 0.76 |
| Arm 1 SSM Intervention | Total Stroke Specific Quality of Life | 3 months outcome | 4.01 units on a scale | Standard Deviation 0.72 |
| Arm 1 SSM Intervention | Total Stroke Specific Quality of Life | Mean Change from 0 to 6 months | 0.268 units on a scale | Standard Deviation 0.06 |
| Arm 1 SSM Intervention | Total Stroke Specific Quality of Life | Baseline | 3.80 units on a scale | Standard Deviation 0.73 |
| Arm 1 SSM Intervention | Total Stroke Specific Quality of Life | Mean Change from 0 to 12 months | 0.214 units on a scale | Standard Deviation 0.04 |
| Arm 1 SSM Intervention | Total Stroke Specific Quality of Life | 6 months outcome | 4.07 units on a scale | Standard Deviation 0.75 |
| Arm 2 Usual Care | Total Stroke Specific Quality of Life | Mean Change from 0 to 12 months | 0.181 units on a scale | Standard Deviation 0.04 |
| Arm 2 Usual Care | Total Stroke Specific Quality of Life | Baseline | 3.82 units on a scale | Standard Deviation 0.768 |
| Arm 2 Usual Care | Total Stroke Specific Quality of Life | 3 months outcome | 3.94 units on a scale | Standard Deviation 0.79 |
| Arm 2 Usual Care | Total Stroke Specific Quality of Life | 6 months outcome | 3.95 units on a scale | Standard Deviation 0.78 |
| Arm 2 Usual Care | Total Stroke Specific Quality of Life | Mean Change from 0 to 6 months | 0.133 units on a scale | Standard Deviation 0.05 |
| Arm 2 Usual Care | Total Stroke Specific Quality of Life | 12 months outcome | 4.00 units on a scale | Standard Deviation 0.77 |
Comparison: All the sample size calculations were powered at 80% with a 5% Type I error. We estimated based on our pilot study a change difference of 0.25 on Total Stroke Specific Quality of Life in the intervention group compared to no change in the control group at 6 months. Our power calculations estimated a sample of 226 (113) per group was needed to detect this effect. We used primary outcome row Mean Change from 0 to 6 months for this analysis.p-value: 0.05Mixed Models Analysis
Comparison: We evaluated the mean difference on Total Stroke Specific Quality of Life compared to baseline between the intervention and control groups at 12 months using repeated measures ANCOVA models. We used primary outcome row Mean change from 0 to 12 months for this analysis.p-value: 0.26Mixed Models Analysis