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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 SSM Intervention | Experimental | 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. |
|
| Arm 2 Usual Care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stroke Self-Management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 6 months |
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Inclusion Criteria:
Patient eligibility criteria include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa M. Damush, PhD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States | ||
| Richard L. Roudebush VA Medical Center, Indianapolis, IN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29200181 | Background | Chen CX, Kroenke K, Stump TE, Kean J, Carpenter JS, Krebs EE, Bair MJ, Damush TM, Monahan PO. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018 Apr;159(4):775-782. doi: 10.1097/j.pain.0000000000001121. | |
| 30529442 | Result |
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Limited deidentified dataset will be shared after publication completion from study.
Limited de-identified dataset will be shared after publication completion beginning 2022 for 5 years.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 SSM Intervention | 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. |
| FG001 | Arm 2 Usual Care | Usual care for treating a patient presenting with an acute ischemic stroke or TIA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 6 Month Assessment |
| |||||||||||||
| 6 Month to 12 Month Assessment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants were patients discharged with an acute stroke or TIA as the primary diagnoses. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 6 months |
|
Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events.
All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study.
SAE were defined as a health event for which the participant was hospitalized for medical care.
AE were defined as a health event experienced and treated by medical personnel but not hospitalized.
Deaths were reported as any death occurring during the participant enrollment in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 SSM Intervention | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CVD related health event | Vascular disorders | Systematic Assessment | Health event required hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Outpatient Care | General disorders | Systematic Assessment | Participant was not hospitalized Any health event for which medical care was received but not admitted into hospital. |
Participants who agreed to participate may have had a greater interest in managing their health compared to the general population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Damush Ph.D. | VA HSRD PRIS-M QUERI and CHIC HSRD Centers | 317-988-4277 | Teresa.Damush@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2016 | Oct 23, 2018 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Non VA Informed Consent | Feb 11, 2016 | Mar 2, 2018 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: VA Informed consent | Feb 11, 2016 | Mar 2, 2018 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Indianapolis |
| Indiana |
| 46202-2884 |
| United States |
| Chen CX, Kroenke K, Stump T, Kean J, Krebs EE, Bair MJ, Damush T, Monahan PO. Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials. J Pain. 2019 Jun;20(6):664-675. doi: 10.1016/j.jpain.2018.11.010. Epub 2018 Dec 6. |
| 32056864 | Result | Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. J Affect Disord. 2020 Apr 1;266:100-108. doi: 10.1016/j.jad.2020.01.101. Epub 2020 Jan 23. |
| 33541362 | Result | Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health Qual Life Outcomes. 2021 Feb 4;19(1):41. doi: 10.1186/s12955-021-01674-3. |
| 34052655 | Derived | Kroenke K, Stump TE, Kean J, Krebs EE, Damush TM, Bair MJ, Monahan PO. Diagnostic operating characteristics of PROMIS scales in screening for depression. J Psychosom Res. 2021 Aug;147:110532. doi: 10.1016/j.jpsychores.2021.110532. Epub 2021 May 25. |
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| BG001 | Usual Care Arm 2 | Usual care which includes standardized patient education materials on stroke from the American Stroke Association. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Cerebrovascular Events | Participants who had a diagnosed stroke or TIA as primary diagnoses at discharge from an inpatient admission | Count of Participants | Participants |
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| National Institute on Health Stroke Scale (NIHSS) | NIHSS is a clinical assessment of stroke severity and disability at time of stroke. This scale captures total stroke deficits in several domains (consciousness, vision, extraocular movement, facial control, limb strength, ataxia, sensation, and speech and language. Each item is scored and total score is sum of all items. Score ranges from [0 to 42] where 0 reflects no stroke disability and scores between 21-42 indicate severe stroke disability. Scores between 1-4 = minor stroke; Scores between 5-15= moderate stroke; and Scores between 15-20= moderate/severe stroke disability. | Mean | Standard Deviation | units on a scale |
|
| Length of time (days) | Days from hospital discharge to study enrollment | Number | Days |
|
| Stroke Specific Quality of Life | Stroke Specific, Health-Related Quality of Life. Self-reported measure includes 12 domains over 49 items and an Overall Total Score. Items are scored on a 5 point Likert response format with lower score indicating worse function/lower ability on that item and a higher score indicating better function. Domain score were calculated as an unweighted average of item scores in that specific domain. Overall Stroke Specific, Health-Related Quality of Life = average items 50-62 where a lower score indicates worse health now compared to before the stroke event. | Mean | Standard Deviation | units on a scale |
|
| Self-Efficacy to Manage Stroke Symptoms | Assesses confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and 1 denotes no confidence. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Arm 2 Usual Care | Usual care for acute stroke care services |
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|
|
| 2 |
| 129 |
| 44 |
| 129 |
| 72 |
| 129 |
| EG001 | Arm 2 Usual Care | Usual care for acute ischemic stroke | 2 | 129 | 35 | 129 | 61 | 129 |
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| Bone fractures and strains | Musculoskeletal and connective tissue disorders | Systematic Assessment | Falls and injuries |
|
| Infection | Infections and infestations | Systematic Assessment | Infections |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| General disorders | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment | Reported pain other than chest pain |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |