Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stroke Self-Management
Sponsored by

About this trial
This is an interventional health services research trial for Stroke focused on measuring Stroke, Self-Management, Transient ischemic attack, Self-Efficacy
Eligibility Criteria
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).
Sites / Locations
- Jesse Brown VA Medical Center, Chicago, IL
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm 1 SSM Intervention
Arm 2 Usual Care
Arm Description
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.
Usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01507688
First Posted
January 4, 2012
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01507688
Brief Title
Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life
Official Title
Stroke Self-Management: Effect on Function and Stroke Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
August 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Self-Management, Transient ischemic attack, Self-Efficacy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 SSM Intervention
Arm Type
Experimental
Arm Description
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 Title
Arm 2 Usual Care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Stroke Self-Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Stroke Specific Quality of Life
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa M. Damush, PhD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Limited deidentified dataset will be shared after publication completion from study.
IPD Sharing Time Frame
Limited de-identified dataset will be shared after publication completion beginning 2022 for 5 years.
Citations:
PubMed Identifier
29200181
Citation
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.
Results Reference
background
PubMed Identifier
30529442
Citation
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.
Results Reference
result
PubMed Identifier
32056864
Citation
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.
Results Reference
result
PubMed Identifier
33541362
Citation
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.
Results Reference
result
PubMed Identifier
34052655
Citation
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.
Results Reference
derived
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Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life
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