Ischemic Stroke, Transient Ischemic Attack
Conditions
Keywords
Ischemic stroke, Preventive medicine, Transient Ischemic Attack, Neurology, Risk management
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.
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.
Interventions
Received Phone Calls from Staff to Control for Attention
BEHAVIORALPhysician 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
BEHAVIORALStroke Self 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
Sponsors
Indiana University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Specific Health Related Quality of Life | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | baseline, 6 months | * 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% |
| Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | baseline, 6 months | * 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%. |
| Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | Baseline, 6 months | * 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%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 87 |
| Attention Control Group Received Phone Calls from Staff to Control for Attention | 87 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 8 |
| Overall Study | Withdrawal by Subject | 8 | 12 |
Baseline characteristics
| Characteristic | Total | Attention Control Group | Arm 1 Stroke Self Management and Risk Factor Program |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 9.5 | 62.1 years STANDARD_DEVIATION 9.4 | 60.4 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 83 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire (PHQ)9 Depressive Symptoms | 7.00 units on a scale STANDARD_DEVIATION 6.34 | 6.82 units on a scale STANDARD_DEVIATION 6.68 | 7.72 units on a scale STANDARD_DEVIATION 6.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 29 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) White | 105 Participants | 51 Participants | 54 Participants |
| Self-Efficacy to Communicate with Physician | 2.32 units on a scale STANDARD_DEVIATION 1.16 | 2.56 units on a scale STANDARD_DEVIATION 1.28 | 2.08 units on a scale STANDARD_DEVIATION 0.96 |
| Self-Efficacy to Manage Stroke | 8.14 units on a scale STANDARD_DEVIATION 1.6 | 8.30 units on a scale STANDARD_DEVIATION 1.6 | 7.72 units on a scale STANDARD_DEVIATION 1.68 |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 169 Participants | 85 Participants | 84 Participants |
| Stroke Specific, Health-Related Quality of Life | 3.84 units on a scale STANDARD_DEVIATION 0.72 | 3.92 units on a scale STANDARD_DEVIATION 0.72 | 3.72 units on a scale STANDARD_DEVIATION 0.68 |
| Stroke Specific Health Related Quality of Life Perceived Energy | 3.04 units on a scale STANDARD_DEVIATION 1.36 | 3.30 units on a scale STANDARD_DEVIATION 1.36 | 2.62 units on a scale STANDARD_DEVIATION 1.24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 87 | 0 / 87 |
| serious Total, serious adverse events | 0 / 87 | 0 / 87 |
Outcome results
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Stroke Self Management and Risk Factor Program | Self-Efficacy to Manage Stroke Symptoms | 7.90 units on a scale | Standard Deviation 1.78 |
| Attention Control Group | Self-Efficacy to Manage Stroke Symptoms | 8.08 units on a scale | Standard Deviation 1.8 |
p-value: 0.66Mixed Models Analysis
Primary
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.
Time frame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 Stroke Self Management and Risk Factor Program | Stroke Specific Health Related Quality of Life | Overall Total Score | 3.80 units on a scale | Standard Deviation 0.9 |
| Arm 1 Stroke Self Management and Risk Factor Program | Stroke Specific Health Related Quality of Life | Perceived Energy Score | 2.98 units on a scale | Standard Deviation 1.56 |
| Attention Control Group | Stroke Specific Health Related Quality of Life | Overall Total Score | 3.94 units on a scale | Standard Deviation 0.82 |
| Attention Control Group | Stroke Specific Health Related Quality of Life | Perceived Energy Score | 3.04 units on a scale | Standard Deviation 1.42 |
Comparison: This is an analysis of the outcome, Stroke Specific Quality of Life Overall Total Score.p-value: 0.69Mixed Models Analysis
Comparison: This is an analysis of the Perceived Energy Domain within the Stroke Specific Quality of Life Measurep-value: 0.05Mixed Models Analysis
Secondary
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%
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | >=80% Compliance at baseline | 13 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | <80% Compliance at baseline | 19 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | >=80% Compliance at 6 months | 21 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | <80% Compliance at 6 months | 11 participants |
| Attention Control Group | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | <80% Compliance at 6 months | 8 participants |
| Attention Control Group | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | >=80% Compliance at baseline | 8 participants |
| Attention Control Group | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | >=80% Compliance at 6 months | 6 participants |
| Attention Control Group | Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment | <80% Compliance at baseline | 6 participants |
p-value: 0.0695% CI: [0.88, 51.31]Regression, Logistic
Comparison: Within group Intervention Pre Post Comparison Compliance with Diabetes Medicationp-value: 0.03695% CI: [1.08, 10.96]Regression, Logistic
Comparison: Within Group attention control group intervention pre post comparison compliance with Diabetes Medicationp-value: 0.40795% CI: [0.1, 2.7]Regression, Logistic
Secondary
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%.
Time frame: Baseline, 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at baseline | 39 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at baseline | 40 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at 6 months | 61 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at 6 months | 18 participants |
| Attention Control Group | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at 6 months | 22 participants |
| Attention Control Group | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at baseline | 41 participants |
| Attention Control Group | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at 6 months | 48 participants |
| Attention Control Group | Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at baseline | 29 participants |
Comparison: Between Group Intervention Pre Post Comparison Compliance with Hypertension Medicationp-value: 0.09695% CI: [0.86, 6.4]Regression, Logistic
Comparison: Within Group Intervention Pre Post Comparison Compliance with Hypertension Medicationp-value: 0.000495% CI: [1.81, 7.48]Regression, Logistic
Comparison: Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication.p-value: 0.2195% CI: [0.77, 3.21]Regression, Logistic
Secondary
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%.
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at baseline | 16 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at baseline | 56 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at 6 months | 44 participants |
| Arm 1 Stroke Self Management and Risk Factor Program | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at 6 months | 28 participants |
| Attention Control Group | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at 6 months | 32 participants |
| Attention Control Group | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at baseline | 18 participants |
| Attention Control Group | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | >=80% Compliance at 6 months | 39 participants |
| Attention Control Group | Medication (Statins) for Secondary Stroke Prevention Risk Factor Management | <80% Compliance at baseline | 53 participants |
Comparison: Between Group Intervention Pre Post Comparison Compliance with Statin Medicationp-value: 0.0595% CI: [0.54, 4.48]Regression, Logistic
Comparison: Within Group Intervention Pre Post Comparison Compliance with Statin Medicationp-value: 0.000195% CI: [2.81, 12.76]Regression, Logistic
Comparison: Within Group Attention Control Pre Post Comparison Compliance with Statin Medication.p-value: 0.000495% CI: [1.83, 8.01]Regression, Logistic