Adapting Tools to Implement Stroke Risk Management to Veterans
TOOLS
3 other identifiers
interventional
174
1 country
2
Brief Summary
The purpose of this study is to develop and evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and evidence based guidelines for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider. We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2006
CompletedFirst Posted
Study publicly available on registry
July 21, 2006
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
February 10, 2015
CompletedOctober 11, 2018
September 1, 2018
2.4 years
July 18, 2006
July 15, 2014
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stroke Specific Health Related Quality of Life
* Stroke Specifc, Health Related Quality of Life (SSQoL) * Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369. * Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores. We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05.
6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
Self-Efficacy to Manage Stroke Symptoms
Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.
6 months
Secondary Outcomes (3)
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment
baseline, 6 months
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management
baseline, 6 months
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management
Baseline, 6 months
Study Arms (2)
Arm 1 Secondary Risk Factor Management
EXPERIMENTALPatient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence
Attention Control Group
PLACEBO COMPARATORReceived Phone Calls from Staff to Control for Attention
Interventions
Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA
Received Phone Calls from Staff to Control for Attention
Eligibility Criteria
You may qualify if:
- Veterans 18 years or older hospitalized with stroke or Transient Ischemic Attack at Indianapolis Veterans Administration Medical Center and Houston Veteran Administration Medical Center;
- willing to participate;
- access to telephone;
- speaks and understands English;
- no severe cognitive impairments;
- life expectancy of at least 6 mos;
- willingness to follow-up in Veterans Administration outpatient care.
You may not qualify if:
- Severe aphasia or cognitive impairment;
- active alcohol or substance abuse;
- cannot or unwilling to participate;
- does not speak or understand English;
- life expectancy less than 6 mos;
- no access to telephone;
- no Veterans Administration outpatient follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Indiana Universitycollaborator
Study Sites (2)
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030, United States
Related Publications (4)
Schmid AA, Andersen J, Kent T, Williams LS, Damush TM. Using intervention mapping to develop and adapt a secondary stroke prevention program in Veterans Health Administration medical centers. Implement Sci. 2010 Dec 15;5:97. doi: 10.1186/1748-5908-5-97.
PMID: 21159171RESULTDamush TM, Jackson GL, Powers BJ, Bosworth HB, Cheng E, Anderson J, Guihan M, LaVela S, Rajan S, Plue L. Implementing evidence-based patient self-management programs in the Veterans Health Administration: perspectives on delivery system design considerations. J Gen Intern Med. 2010 Jan;25 Suppl 1(Suppl 1):68-71. doi: 10.1007/s11606-009-1123-5.
PMID: 20077155RESULTCrocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PMID: 34813082DERIVEDDamush TM, Myers L, Anderson JA, Yu Z, Ofner S, Nicholas G, Kimmel B, Schmid AA, Kent T, Williams LS. The effect of a locally adapted, secondary stroke risk factor self-management program on medication adherence among veterans with stroke/TIA. Transl Behav Med. 2016 Sep;6(3):457-68. doi: 10.1007/s13142-015-0348-6.
PMID: 27349906DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Both our intervention and control groups experienced attrition during the study period but the rate between groups did not differ significantly.
Results Point of Contact
- Title
- Teresa Damush, Ph.D.
- Organization
- VA Stroke QUERI Center, Roudebush VAMC
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa M. Damush, PhD
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2006
First Posted
July 21, 2006
Study Start
January 1, 2009
Primary Completion
June 1, 2011
Study Completion
December 1, 2013
Last Updated
October 11, 2018
Results First Posted
February 10, 2015
Record last verified: 2018-09