HealthMap: an Interactive Health Plan Randomised Trial to Prevent Cardiovascular Disease in People With HIV

HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; HIV
• Intervention / Treatment: Other: Integrated self management support

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 731
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Alexandra, New South Wales, Australia, 2015
      • Fountain Street General Practice
    • Coffs Harbour, New South Wales, Australia, 2450
      • Coffs Central Medical Centre
    • Port Macquarie, New South Wales, Australia, 2444
      • CPC Medical Practice
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Sydney, New South Wales, Australia, 2010
      • East Sydney Doctors
  • South Australia
    • Adelaide, South Australia, Australia, 5042
      • Riverside Family Medical Practice
  • Victoria
    • Melbourne, Victoria, Australia, 3168
      • Monash Medical Centre
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
    • Melbourne, Victoria, Australia, 3053
      • Melbourne Sexual Health Centre
    • Melbourne, Victoria, Australia, 3182
      • Centre Clinic
    • Melbourne, Victoria, Australia, 3068
      • Northside Clinic
    • Melbourne, Victoria, Australia, 3181
      • Prahran Market Clinic
    • Melbourne, Victoria, Australia, 3121
      • Richmond Hill Medical Centre
    • Melbourne, Victoria, Australia, 3143
      • Recreation Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Integrated self management support; 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.	Other: Integrated self management support; The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Coronary heart disease Framingham risk equation is obtained from: Wilson P, D'Agostino R, Levy D, Belanger A, Silbershatz H, et al. (1998) Prediction of Coronary Heart Disease Using Risk Factor Categories. Circulation 97: 1837 - 1847.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables		12 months
Cardiovascular risk as estimated by an HIV-specific risk score	(Worm Signe W, Sabin C, Weber R, Reiss P, El Sadr W, et al. (2010) Risk of Myocardial Infarction in Patients with HIV Infection Exposed to Specific Individual Antiretroviral Drugs from the 3 Major Drug Classes: The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study. The Journal of Infectious Diseases 201: 318-330.)	12 months
Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study		12 months
Fasting total cholesterol and total cholesterol:HDL ratio	(measured by serum assay)	12 months
Systolic blood pressure	(using a sphygmomanometer)	12 months
Body mass index and waist circumference	Body mass index (calculated by weight in kilograms divided by height in metres squared; these are measured using a scale and stadiometer) and waist circumference (measured using a flexible steel measuring tape)	12 months
Proportion of patients achieving Australian cardiovascular risk factor management targets	(http://strokefoundation.com.au/healthprofessionals/ clinical-guidelines/guidelines-for-the-assessment-andmanagement- of-absolute-cvd-risk/)	12 months
Quality of life as measured by the AQoL-4D instrument		12 months
Mental health status as measured by the DASS instrument		12 months
Self-management capacity as measured by the heiQ instrument		12 months
Proportion of patients with HIV virological suppression	(Below the lower limit of detection of the assay used )	12 months
Proportion of patients achieving HIV quality of care measures		12 months
Evaluation of the intervention program (intervention arm only)	using a questionnaire designed specifically for this study and using structured interviews.	12 months
Health care provider related: Evaluation of the intervention program intervention arm only)	Evaluation of the intervention program (intervention arm only) using a questionnaire designed specifically for this study and using structured interviews.	12 months

Collaborators and Investigators

• Sponsor: Karen Klassen
• Collaborators: National Health and Medical Research Council, Australia; Monash University; The Alfred; University of Melbourne; Flinders University; Deakin University; Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine; National Association of People with HIV Australia; Victorian AIDS Council; Department of Health & Human Services, State Government of Victoria, Australia; Living Positive Victoria; NSW Ministry of Health
• Investigators: Principal Investigator: Julian Elliott, Monash University

Publications and helpful links

General Publications

• Dodson S, Klassen KM, McDonald K, Millard T, Osborne RH, Battersby MW, Fairley CK, Simpson JA, Lorgelly P, Tonkin A, Roney J, Slavin S, Sterjovski J, Brereton M, Lewin SR, Crooks L, Watson J, Kidd MR, Williams I, Elliott JH. HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV. BMC Infect Dis. 2016 Mar 5;16:114. doi: 10.1186/s12879-016-1422-5.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: June 29, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 1, 2014

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: HIV; quality of life; self-management; cardiovascular disease; self-efficacy; HIV co-morbidities; coronary heart disease risk
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: U1111-1150-6489