Case Managers for CVD Risk Reduction in HIV Clinic

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839394
• Other study ID #: Pro00085562
• Secondary ID: K23HL137611-01A1
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: September 14, 2023

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• HIV

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	baseline, 24 weeks, 48 weeks, 72 weeks
Primary	Change in fasting LDL-c levels	Assessment of the absolute change in fasting calculated low density lipoprotein cholesterol over the study period.	baseline, 24 weeks, 48 weeks, 72 weeks
Secondary	Total weight loss	Total weight loss from baseline over the study period.	baseline, 24 weeks, 48 weeks, 72 weeks
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.	baseline, 24 weeks, 48 weeks, 72 weeks

External Links

•   Website referring to educational materials to be shared as part of this intervention
•   Website referring to educational materials to be shared as part of this intervention