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Case Managers for CVD Risk Reduction in HIV Clinic

Sponsor
Duke University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03839394
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
50
Enrollment
1
Location
2
Arms
34.6
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telephone
  • Other: Educational pamphlets
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV
Actual Study Start Date :
Oct 12, 2020
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Educational pamphlets + telephone

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.
Active Comparator: Educational pamphlets

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Change in fasting LDL-c levels [baseline, 24 weeks, 48 weeks, 72 weeks]

    Assessment of the absolute change in fasting calculated low density lipoprotein cholesterol over the study period.

Secondary Outcome Measures

  1. Total weight loss [baseline, 24 weeks, 48 weeks, 72 weeks]

    Total weight loss from baseline over the study period.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27701

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Nwora L Okeke, MD, MPH, Duke University

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03839394
Other Study ID Numbers:
  • Pro00085562
  • K23HL137611-01A1
First Posted:
Feb 15, 2019
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Mar 18, 2022