Hyperlipidemia, Hypertension, Stroke, TIA
Conditions
Keywords
stroke, recurrence, blood pressure, prevention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTI
Tailored intervention based on the transtheoretical model
BEHAVIORALAP
Attention placebo
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Well-documented history of stroke or TIA that occurred at least 3 months prior to enrollment; * Age 21 years or older; * Continuity of care in the VAMC primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year; * On hypertensive and/or lipid-lowering agents; * A score of \>16 on the Mini-Mental Status Exam; * ability to exercise (assessed by 6-minute walk or timed get up and go).
Exclusion criteria
* Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer; * No telephone number at which patient can be reached; * Plans to relocate outside of the NYC area within the next 6 months; * Inability to communicate over the telephone due to severe cognitive impairment or aphasia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic Blood Pressure | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Adherence | 6 months | Measured by 7-day Physical Activity Recall |
| Total Cholesterol/High Density Lipoprotein Ratio | 6 months | — |
| Dietary Sodium | 6 months | 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) |
| Antihypertensive/ Lipid-lowering Medication Adherence | 6 months | Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Tailored Intervention (TI) Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model | 66 |
| Attention Placebo (AP) General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening) | 74 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Tailored Intervention (TI) | Attention Placebo (AP) | Total |
|---|---|---|---|
| Age, Continuous | 66.38 years STANDARD_DEVIATION 9.86 | 68.73 years STANDARD_DEVIATION 10.3 | 67.62 years STANDARD_DEVIATION 10.13 |
| Race/Ethnicity, Customized Black/African American (non-Hispanic) | 35 participants | 34 participants | 69 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 6 participants | 9 participants | 15 participants |
| Race/Ethnicity, Customized Other | 3 participants | 4 participants | 7 participants |
| Race/Ethnicity, Customized Refused | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White (non-Hispanic) | 21 participants | 27 participants | 48 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 64 Participants | 74 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 66 | 9 / 74 |
| serious Total, serious adverse events | 1 / 66 | 2 / 74 |
Outcome results
Primary
Systolic Blood Pressure
Time frame: 6 months
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tailored Intervention (TI) | Systolic Blood Pressure | 130.83 mm Hg |
| Attention Placebo (AP) | Systolic Blood Pressure | 133.67 mm Hg |
Comparison: Robust regressions were performedp-value: 0.29robust regression
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
Time frame: 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Intervention (TI) | Antihypertensive/ Lipid-lowering Medication Adherence | 3.58 units on a scale | Standard Deviation 0.76 |
| Attention Placebo (AP) | Antihypertensive/ Lipid-lowering Medication Adherence | 3.43 units on a scale | Standard Deviation 0.79 |
p-value: 0.12Regression, Linear
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)
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tailored Intervention (TI) | Dietary Sodium | pre-action | 11 participants |
| Tailored Intervention (TI) | Dietary Sodium | Action or Maintenance | 52 participants |
| Attention Placebo (AP) | Dietary Sodium | Action or Maintenance | 52 participants |
| Attention Placebo (AP) | Dietary Sodium | pre-action | 18 participants |
p-value: 0.25Regression, Logistic
Secondary
Exercise Adherence
Measured by 7-day Physical Activity Recall
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tailored Intervention (TI) | Exercise Adherence | 2.50 hours per week of cardio |
| Attention Placebo (AP) | Exercise Adherence | 2.75 hours per week of cardio |
p-value: 0.81Regression, Linear
Secondary
Total Cholesterol/High Density Lipoprotein Ratio
Time frame: 6 months
Population: Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tailored Intervention (TI) | Total Cholesterol/High Density Lipoprotein Ratio | 3.47 ratio |
| Attention Placebo (AP) | Total Cholesterol/High Density Lipoprotein Ratio | 3.21 ratio |
p-value: 0.11Wilcoxon (Mann-Whitney)