Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 0608-01B | Other Grant/Funding Number | US Veterans Health Administration | |
| 1009001684 | Other Grant/Funding Number | US Veterans Health Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indiana University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Attention Control Group | Placebo Comparator | Received Phone Calls from Staff to Control for Attention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician stroke guideline adherence | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Specific Health Related Quality of Life |
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment |
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teresa M. Damush, PhD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21159171 | Result | 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. | |
| 20077155 | Result | Damush 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 Stroke Prevention Intervention | Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support. |
| FG001 | Arm 2 Control Group | Received usual care, follow up telephone calls to control for contact, and educational materials |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Compared groups on strata, age, sex, race/ethnicity, education level, living status, has Caregiver Number of participants were determined by protocol and followed intention to treat. For 3 and 6 month outcomes, we included respondent's last score assuming no change among those with missing data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 Stroke Self Management and Risk Factor Program | Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support Physician stroke guideline adherence: 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 Secondary Stroke Self-Management and Risk Factor Management: 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/Transcient Ischemic Attack |
| 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 | Stroke Specific Health Related Quality of Life |
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. | 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. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, and time. | Posted | Mean | Standard Deviation | units on a scale | 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain |
Continuously throughout study intervention period of 6 months
Not provided
Not provided
| 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 Stroke Self Management and Risk Factor Program | Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support Physician stroke guideline adherence: 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 Secondary Stroke Self-Management and Risk Factor Management: 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 |
Not provided
Not provided
Both our intervention and control groups experienced attrition during the study period but the rate between groups did not differ significantly.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Damush, Ph.D. | VA Stroke QUERI Center, Roudebush VAMC | 317-988-4277 | Teresa.Damush@va.gov |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Stroke Self Management | Behavioral | 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 Group | Other | Received Phone Calls from Staff to Control for Attention |
|
| 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 |
| Michael E. DeBakey VA Medical Center, Houston, TX |
| Houston |
| Texas |
| 77030 |
| United States |
| 34813082 | Derived | Crocker 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. |
| 27349906 | Derived | Damush 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. |
| BG001 | Attention Control Group | Received Phone Calls from Staff to Control for Attention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Self reported description of respondent's sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Stroke Specific, Health-Related Quality of Life | Stroke, specific, health-related quality of life (SSQoL) is a self-reported survey by LS Williams et al Stroke. 1999;30:1362-1369. Includes 12 domains and 49 items which are scored on a 5pt 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. Each Domain Score and the Overall Total Score all range from 1-5 with 1 being worst and 5 best best. | Mean | Standard Deviation | units on a scale |
|
| Self-Efficacy to Manage Stroke | This scale is modified from the Arthitis Self-Efficacy scale and is designed to measure Confidence to Manage Stroke Symptoms. The items measure the 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. The scale score is the average score of the items. | Mean | Standard Deviation | units on a scale |
|
| Self-Efficacy to Communicate with Physician | The scale designed by K Lorig measures the confidence to communicate with a physician about the patient's health. The response items range from 1-10 where 10 denotes a lot of confidence and a 1 denotes no confidence. The score equals the average of the items. | Mean | Standard Deviation | units on a scale |
|
| Stroke Specific Health Related Quality of Life Perceived Energy | Perceived Energy Subdomain of the Stroke Specific Quality of Life measures perceived energy after stroke. Item response is on a 5 point Likert scale where 1 denotes worse functioning and 5 denotes best functioning. Domain score was calculated as an unweighted average of item scores in the Energy subdomain. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire (PHQ)9 Depressive Symptoms | PHQ9 is a commonly used scale to measure the degree by which a respondent was bothered by depressive symptoms during the past 2 weeks by Spitzer, Williams, and Kroenke. Each of the 9 items use a 0-3 item response where 0 = "not at all" and 3 ="nearly every day." Total score is the sum of the 9 items. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Arm 1 Stroke Self Management and Risk Factor Program | Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support Physician stroke guideline adherence: 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 Secondary Stroke Self-Management and Risk Factor Management: 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 |
| OG001 | Attention Control Group | Received Phone Calls from Staff to Control for Attention |
|
|
|
| Primary | 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. | We hypothesized the intervention group would report significantly greater self-efficacy to manage stroke symptoms than the control group. Level of significance was set to .05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, & time. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment |
| We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses. | Posted | Number | participants | baseline, 6 months |
|
|
|
|
| Secondary | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management |
| We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses. | Posted | Number | participants | baseline, 6 months |
|
|
|
|
| Secondary | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management |
| We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses. | Posted | Number | participants | Baseline, 6 months |
|
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | Attention Control Group | Received Phone Calls from Staff to Control for Attention | 0 | 87 | 0 | 87 |
Not provided
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| >=80% Compliance at 6 months |
|
| <80% Compliance at 6 months |
|
| 0.036 |
| Odds Ratio (OR) |
| 3.45 |
| 2-Sided |
| 95 |
| 1.08 |
| 10.96 |
| Superiority or Other |
| Within Group attention control group intervention pre post comparison compliance with Diabetes Medication | Regression, Logistic | 0.407 | Odds Ratio (OR) | 0.51 | 2-Sided | 95 | 0.10 | 2.70 | Superiority or Other |
| >=80% Compliance at 6 months |
|
| <80% Compliance at 6 months |
|
| Regression, Logistic |
| 0.0001 |
| Odds Ratio (OR) |
| 5.98 |
| 2-Sided |
| 95 |
| 2.81 |
| 12.76 |
| Superiority or Other |
| Within Group Attention Control Pre Post Comparison Compliance with Statin Medication. | Regression, Logistic | 0.0004 | Odds Ratio (OR) | 3.83 | 2-Sided | 95 | 1.83 | 8.01 | Superiority or Other |
| >=80% Compliance at 6 months |
|
| <80% Compliance at 6 months |
|
| Regression, Logistic |
| 0.0004 |
| Odds Ratio (OR) |
| 3.68 |
| 2-Sided |
| 95 |
| 1.81 |
| 7.48 |
| Superiority or Other |
| Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication. | Regression, Logistic | 0.21 | Odds Ratio (OR) | 1.57 | 2-Sided | 95 | 0.77 | 3.21 | Superiority or Other |