Cardiovascular Disease, HIV
Conditions
Brief summary
The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.
Detailed description
Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum delivered over 24 weeks \[intervention arm\], or the educational pamphlets alone \[control arm\]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from patients to assess the efficacy of the intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL).
Interventions
BEHAVIORALTelephone
A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
OTHEREducational pamphlets
A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months * On antiretroviral therapy * 2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of either hypertension or hyperlipidemia * English literate (able to speak and read at a 6th grade level) * Subjects must have the capacity to give legally effective consent.
Exclusion criteria
* Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ambulatory Systolic Blood Pressure | Baseline, 24 weeks, 48 weeks, 72 weeks | Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve \>5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks. |
| Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline | Baseline, 72 weeks | — |
| Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels | Baseline, 24 weeks, 48 weeks, 72 weeks | Assessment of the absolute change in fasting calculated non-high density lipoprotein cholesterol over the study period. Reported here is the change from baseline to 72 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Change in Body Weight | Baseline, 24 weeks, 48 weeks, 72 weeks | Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks. |
| Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score | Baseline, 24 weeks, 48 weeks, 72 weeks | The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator. The ASCVD risk score is a calculation of the 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. The ASCVD risk score is given as a percentage, which represents the chance of having heart disease or stroke in the next 10 years. 0 to 4.9 = low risk, 5 to 7.4 = borderline risk, 7.5 to 20 = intermediate risk, \>20 = high risk. Reported here is the change from baseline to 72 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Educational Pamphlets + Telephone Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. | 25 |
| Educational Pamphlets Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Educational Pamphlets + Telephone | Total | Educational Pamphlets |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 6.1 | 56.5 years STANDARD_DEVIATION 7.7 | 54.0 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 47 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 35 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 11 Participants | 7 Participants |
| Region of Enrollment United States | 25 Participants | 49 Participants | 24 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 20 Participants | 39 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 9 / 25 | 3 / 24 |
| serious Total, serious adverse events | 3 / 25 | 3 / 24 |
Outcome results
Primary
Change in Ambulatory Systolic Blood Pressure
Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve \>5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Pamphlets + Telephone | Change in Ambulatory Systolic Blood Pressure | 1.9 mmHg | Standard Deviation 15 |
| Educational Pamphlets | Change in Ambulatory Systolic Blood Pressure | -10.7 mmHg | Standard Deviation 10.9 |
Comparison: This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.p-value: 0.012t-test, 2 sided
Primary
Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels
Assessment of the absolute change in fasting calculated non-high density lipoprotein cholesterol over the study period. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Pamphlets + Telephone | Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels | -5.7 mg/dL | Standard Deviation 36.2 |
| Educational Pamphlets | Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels | -1.5 mg/dL | Standard Deviation 37.4 |
Comparison: This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.p-value: 0.75t-test, 2 sided
Primary
Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline
Time frame: Baseline, 72 weeks
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Pamphlets + Telephone | Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline | 7 Participants |
| Educational Pamphlets | Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline | 10 Participants |
Comparison: This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.p-value: 0.05Z-test of Proportions
Secondary
Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score
The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator. The ASCVD risk score is a calculation of the 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. The ASCVD risk score is given as a percentage, which represents the chance of having heart disease or stroke in the next 10 years. 0 to 4.9 = low risk, 5 to 7.4 = borderline risk, 7.5 to 20 = intermediate risk, \>20 = high risk. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Pamphlets + Telephone | Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score | -1.0 percentage of risk | Standard Deviation 4.1 |
| Educational Pamphlets | Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score | -0.4 percentage of risk | Standard Deviation 3.3 |
Comparison: This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.p-value: 0.76t-test, 2 sided
Secondary
Total Change in Body Weight
Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Pamphlets + Telephone | Total Change in Body Weight | -1.8 kg | Standard Deviation 5.1 |
| Educational Pamphlets | Total Change in Body Weight | -2.1 kg | Standard Deviation 4.8 |
Comparison: This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.p-value: 0.86t-test, 2 sided