Case Managers for CVD Risk Reduction in HIV Clinic

NCT03839394 | Completed Results DMC

• 2 other identifiers: Pro00085562K23HL137611-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; HIV

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, 24 weeks, 48 weeks, 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

  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.

  Baseline, 24 weeks, 48 weeks, 72 weeks

Secondary Outcomes (2)

• Total Change in Body Weight

  Baseline, 24 weeks, 48 weeks, 72 weeks

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

  Baseline, 24 weeks, 48 weeks, 72 weeks

Study Arms (2)

Educational pamphlets + telephone

EXPERIMENTAL

Behavioral: Telephone; Other: Educational pamphlets

Educational pamphlets

ACTIVE COMPARATOR

Other: Educational pamphlets

Interventions

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 + telephone

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.

Educational pamphlets; Educational pamphlets + telephone

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months
• On antiretroviral therapy
• 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.

You may not qualify if:

• Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Related 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

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Nwora Lance Okeke, MD, MPH
• Organization: Duke University

lance.okeke@duke.edu

919-684-2579

Study Officials

• Nwora L Okeke, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: October 12, 2020
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)