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Completed

NCT Number: NCT03839394

Case Managers for CVD Risk Reduction in HIV Clinic

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases HIV

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone

Behavioral

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

Other

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.

Primary outcomes

  1. Change in Ambulatory Systolic Blood Pressure

    Time frame: 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.

  2. Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline

    Time frame: Baseline, 72 weeks

  3. Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels

    Time frame: 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 outcomes

  1. Total Change in Body Weight

    Time frame: 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.

  2. Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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