N/A
N=49
Case Managers for CVD Risk Reduction in HIV Clinic
Cardiovascular Disease · HIV
Bottom Line
View on ClinicalTrials.gov: NCT03839394 ↗Enrolled (actual)
49
Serious AEs
12.2%
Results posted
Sep 2024
Primary outcome: Primary: Change in Ambulatory Systolic Blood Pressure — 1.9; -10.7 mmHg — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telephone (Behavioral); Educational pamphlets (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ambulatory Systolic Blood Pressure |
1.9; -10.7 | 0.012 sig |
| PRIMARY Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline |
7; 10 | 0.05 |
| PRIMARY Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels |
-5.7; -1.5 | 0.750 |
| SECONDARY Total Change in Body Weight |
-1.8; -2.1 | 0.860 |
| SECONDARY Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score |
-1.0; -0.4 | 0.760 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03839394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.