Case Managers for CVD Risk Reduction in HIV Clinic

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2023-09-14

Brief Summary

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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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Detailed Description

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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).

Conditions

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Cardiovascular Disease HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Educational pamphlets + telephone

Group Type EXPERIMENTAL

Telephone

Intervention Type 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

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Educational pamphlets

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.