Overview

This trial is active, not recruiting.

Conditions hiv, cardiovascular disease
Treatment integrated self management support
Sponsor Karen Klassen
Collaborator The Alfred
Start date August 2014
End date March 2017
Trial size 731 participants
Trial identifier NCT02178930, U1111-1150-6489

Summary

The purpose of this study is to improve the health status of people living with HIV in Australia. The overall goal is to rigorously evaluate the impact of interactive health plans and self-management support on chronic condition outcomes in people with HIV.

The specific aims are to:

Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive health plans and self-management support on coronary heart disease risk and other chronic condition outcomes in people living with HIV.

Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive health plans and self-management support.

Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
The intervention involves the introduction of an interactive chronic disease support platform into doctor-patient consultations, in addition to a self-management support program. Specifically, the intervention comprises the following interlinked components: within consultation engagement; at home exploration; phone and web-based health coaching.
integrated self management support
The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
(No Intervention)
The control group will receive usual care from study sites until all study participants have completed 12 months of follow up from their Baseline Visits. At this point access to the study intervention will be expanded to include control sites.

Primary Outcomes

Measure
The primary study endpoint is 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation
time frame: 12 months

Secondary Outcomes

Measure
Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables
time frame: 12 months
Cardiovascular risk as estimated by an HIV-specific risk score
time frame: 12 months
Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study
time frame: 12 months
Fasting total cholesterol and total cholesterol:HDL ratio
time frame: 12 months
Systolic blood pressure
time frame: 12 months
Body mass index and waist circumference
time frame: 12 months
Proportion of patients achieving Australian cardiovascular risk factor management targets
time frame: 12 months
Quality of life as measured by the AQoL-4D instrument
time frame: 12 months
Mental health status as measured by the DASS instrument
time frame: 12 months
Self-management capacity as measured by the heiQ instrument
time frame: 12 months
Proportion of patients with HIV virological suppression
time frame: 12 months
Proportion of patients achieving HIV quality of care measures
time frame: 12 months
Evaluation of the intervention program (intervention arm only)
time frame: 12 months
Health care provider related: Evaluation of the intervention program intervention arm only)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria: - •HIV infected adults aged 30 years or over. - Receiving ongoing primary HIV and general care at a study site and likely to remain in follow up at that site for 12 months. - Willing and able to provide written informed consent. Exclusion Criteria: - •Diagnosed cardiovascular disease, consisting of coronary heart disease, stroke or transient ischaemia attack, or peripheral arterial disease. - Previous participation in a self-management or coaching program.

Additional Information

Official title HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV
Principal investigator Julian Elliott
Description Participants will be consenting adults 30 years or older without evidence of cardiovascular disease.The study is a pragmatic cluster randomized controlled trial of a complex health system intervention with doctor as the unit of randomization and individual patient outcomes defined as primary and secondary endpoints. The primary endpoint will be assessed in each participant after 12 months of follow up.The study intervention will consist of a programme specifically designed for the Australian clinical context that helps people with HIV and their health care providers achieve best practice targets for modifiable cardiovascular risk factors. The programme will be available to use during routine consultations to present laboratory results, discuss health priorities and describe goals and actions. Patients will be able to access the interactive health plan from home, with associated additional resources, including online peer support. Phone and online health coaching will be available for prioritised patients wanting to reduce their cardiovascular risk. The primary objective is to determine the effect of the intervention on 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation. The secondary objective is to alternative cardiovascular risk scores, individual modifiable cardiovascular risk factors, quality of life, mental health, self- management capacity, process and economic outcomes.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Monash University.