Ischemic StrokeTOOLSNCT00355147
Adapting Tools to Implement Stroke Risk Management to Veterans
A study testing Physician stroke guideline adherence and Stroke Self Management in people with Ischemic Stroke and Transient Ischemic Attack, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Physician stroke guideline adherence and Stroke Self Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
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.
Read the detailed description
Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the American Heart Association, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary Quality Enhancement Research Initiative work indicates that stroke risk factors are often undermanaged in the Veterans Health Administration.
This proposed study of a stroke risk factor management program may benefit the Veteran Health System in several ways. First, it offers a systematic program for reduction in stroke risk factors leading to better health for our veterans and a reduction in inpatient and outpatient rehabilitation and home health services for these events. Second, the Veteran Stroke Prevention Program takes into account the varied resources and services offered in VAMCs across the nation, allowing the program to be tailored both to a given facility and to the individual veteran's needs and readiness to change. Importantly, the program could allow all VA facilities to offer guideline-concurrent stroke risk reduction programs and therefore increase compliance with VA/Department of Defense, American Heart Association, and the Joint Commission stroke care guidelines and improve their quality of stroke care.
Comparison(s): We will compare two regionally matched facilities on rates of secondary stroke prevention guideline care during the course of the study at the intervention sites.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- Physician stroke guideline adherence, Stroke Self Management, Attention Control Group
- Keywords
- Ischemic stroke, Preventive medicine, Transient Ischemic Attack, Neurology, Risk management
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician stroke guideline adherenceBehavioural
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
Stroke Self ManagementBehavioural
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
Attention Control GroupOther
Received Phone Calls from Staff to Control for Attention
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Secondary Risk Factor Management | Experimental | Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence Receives: Behavioral: Physician stroke guideline adherence; Behavioral: Stroke Self Management |
| Attention Control Group | Placebo comparator | Received Phone Calls from Staff to Control for Attention Receives: Other: Attention Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment
- Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data
- Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)
- Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%
Measured: baseline, 6 months
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management
- Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
- Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).
- Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%.
Measured: baseline, 6 months
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management
- Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
- Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)
- Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Teresa M. Damush, PhD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355147
- Sponsor's protocol ID
- IAB 05-297
- Other IDs
- 0608-01B, 1009001684
- Acronym
- TOOLS
- Status last verified
- Sep 2018
- First submitted
- 18 Jul 2006
- Last updated
- 11 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21159171Damush 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.
PubMed 20077155Crocker 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.
PubMed 34813082Damush 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.
PubMed 27349906
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Tools to Implement Stroke Risk Management to Veterans
- ClinicalTrials.gov ID
- NCT00355147
- Acronym / sponsor ID
- TOOLS / IAB 05-297
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- Ischemic stroke, Preventive medicine, Transient Ischemic Attack, Neurology, Risk management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Indiana University
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Jul 2006 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the American Heart Association, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary Quality Enhancement Research Initiative work indicates that stroke risk factors are often undermanaged in the Veterans Health Administration.
This proposed study of a stroke risk factor management program may benefit the Veteran Health System in several ways. First, it offers a systematic program for reduction in stroke risk factors leading to better health for our veterans and a reduction in inpatient and outpatient rehabilitation and home health services for these events. Second, the Veteran Stroke Prevention Program takes into account the varied resources and services offered in VAMCs across the nation, allowing the program to be tailored both to a given facility and to the individual veteran's needs and readiness to change. Importantly, the program could allow all VA facilities to offer guideline-concurrent stroke risk reduction programs and therefore increase compliance with VA/Department of Defense, American Heart Association, and the Joint Commission stroke care guidelines and improve their quality of stroke care.
Comparison(s): We will compare two regionally matched facilities on rates of secondary stroke prevention guideline care during the course of the study at the intervention sites.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Secondary Risk Factor Management | Experimental | Behavioral: Physician stroke guideline adherence, Behavioral: Stroke Self ManagementPatient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence |
| Attention Control Group | Placebo comparator | Other: Attention Control GroupReceived Phone Calls from Staff to Control for Attention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician stroke guideline adherenceProvided 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 | Behavioural | Arm 1 Secondary Risk Factor Management |
| Stroke Self ManagementProvided 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 | Behavioural | Arm 1 Secondary Risk Factor Management |
| Attention Control GroupReceived Phone Calls from Staff to Control for Attention | Other | Attention Control Group |
Primary outcome
Stroke Specific Health Related Quality of Life
Time frame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
* 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.
Self-Efficacy to Manage Stroke Symptoms
Time frame: 6 months
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.
3 secondary outcomes
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment
Time frame: baseline, 6 months
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management
Time frame: baseline, 6 months
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21159171Schmid 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.
- Results publication: PubMed 20077155Damush 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.
- Derived from this study: PubMed 34813082Crocker 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.
- Derived from this study: PubMed 27349906Damush 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa M. Damush, PhD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician stroke guideline adherence and Stroke Self Management in people with Ischemic Stroke and Transient Ischemic Attack, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Specific Health Related Quality of Life (time frame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00355147, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.