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Adults who have had a previous stroke or transient ischemic attack (TIA) remain at risk for having a second serious event, especially if they have uncontrolled blood pressure or cholesterol. However, many patients have difficulty following treatment recommendations for lowering blood pressure and cholesterol. The purpose of this research project is to evaluate the effect of 2 booster sessions of an educational counseling intervention on how well adults who have already participated in a 6-month clinical trial had a stroke or transient ischemic attack (TIA) are able to follow a treatment plan and control their blood pressure and cholesterol levels. We will also examine how effective this intervention is in improving adherence to diet, medication, and physical activity recommendations for adults who have had a prior stroke or TIA.
National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice. We will determine whether a telephone-delivered behaviorally tailored intervention (TI) can lead to sustained change resulting in (a) BP and lipid control and (b) improved adherence to diet, medication, and exercise recommendations in veterans with a history of stroke or TIA compared to an attention placebo (AP) in veterans who have completed 6 months of a clinical trial. In this CDA project, we evaluate the long-term effectiveness of booster sessions in a randomized manner. One arm will receive 6 months of a tailored intervention (TI) followed by two booster TI sessions at 8 and 10 months, and one arm will receive 6 months of an attention placebo (AP) followed by two booster AP sessions at 8 and 10 months. BP (3 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Intervention (TI) | Experimental | Tailored intervention based on the transtheoretical model |
|
| Attention Placebo (AP) | Placebo Comparator | Attention Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TI | Behavioral | Tailored intervention based on the transtheoretical model |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Sodium | self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer P Friedberg, PhD | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | United States |
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Participants were recruited from a prior American Heart Association-funded study testing the effectiveness of a 6-mo TI vs. AP. Participants were recruited at completion of the AHA study to participate in the current study for an additional 6 months. They continued to receive the intervention to which they were originally assigned in the AHA study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Intervention (TI) | Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model |
| FG001 | Attention Placebo (AP) | General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Intervention (TI) | Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model |
| BG001 | Attention Placebo (AP) | General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening) |
| 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 | Systolic Blood Pressure | restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment | Posted | Median | Inter-Quartile Range | mm Hg | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored Intervention (TI) | Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken bone | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Friedberg, Ph.D. | VA New York Harbor Healthcare System | 212-951-3314 | jennifer.friedberg@va.gov |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| AP |
| Behavioral |
Attention placebo |
|
| 6 months |
| Total Cholesterol/High Density Lipoprotein Ratio | 6 months |
| Exercise Adherence | Measured by 7-day Physical Activity Recall | 6 months |
| Antihypertensive/ Lipid-lowering Medication Adherence | Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent | 6 months |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Dietary Sodium | self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago) | Posted | Number | participants | 6 months |
|
|
|
|
| Secondary | Total Cholesterol/High Density Lipoprotein Ratio | Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis | Posted | Median | Inter-Quartile Range | ratio | 6 months |
|
|
|
|
| Secondary | Exercise Adherence | Measured by 7-day Physical Activity Recall | Posted | Median | Inter-Quartile Range | hours per week of cardio | 6 months |
|
|
|
|
| Secondary | Antihypertensive/ Lipid-lowering Medication Adherence | Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent | One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| 1 |
| 66 |
| 9 |
| 66 |
| EG001 | Attention Placebo (AP) | General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening) | 2 | 74 | 9 | 74 |
| Coronary Artery Bypass Graft | Cardiac disorders | Non-systematic Assessment |
|
| Torn Ligament | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bone/Muscle injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |