Clinical trial NCT02178930: HealthMap: an Interactive Health Plan Randomised Trial to Prevent Cardiovascular Disease in People With HIV
Official title: HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Cardiovascular Disease
Keywords: HIV
cardiovascular disease
self-management
HIV co-morbidities
self-efficacy
coronary heart disease risk
quality of life
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: The Alfred
name: Monash University
name: Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine
name: National Association of People with HIV Australia
name: National Health and Medical Research Council, Australia
name: Victorian AIDS Council
name: Department of Health & Human Services, State Government of Victoria, Australia
name: Flinders University
name: Living Positive Victoria
name: NSW Ministry of Health
name: University of Melbourne
name: Deakin University
First posted: 2014-07-01
Enrollment: 731
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

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
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables
timeFrame: 12 months
measure: Cardiovascular risk as estimated by an HIV-specific risk score
timeFrame: 12 months
measure: Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study
timeFrame: 12 months
measure: Fasting total cholesterol and total cholesterol:HDL ratio
timeFrame: 12 months
measure: Systolic blood pressure
timeFrame: 12 months
measure: Body mass index and waist circumference
timeFrame: 12 months
measure: Proportion of patients achieving Australian cardiovascular risk factor management targets
timeFrame: 12 months
measure: Quality of life as measured by the AQoL-4D instrument
timeFrame: 12 months
measure: Mental health status as measured by the DASS instrument
timeFrame: 12 months
measure: Self-management capacity as measured by the heiQ instrument
timeFrame: 12 months
measure: Proportion of patients with HIV virological suppression
timeFrame: 12 months
measure: Proportion of patients achieving HIV quality of care measures
timeFrame: 12 months
measure: Evaluation of the intervention program (intervention arm only)
timeFrame: 12 months
measure: Health care provider related: Evaluation of the intervention program intervention arm only)
timeFrame: 12 months
Other outcomes:
Locations:
city: Alexandra
country: Australia
facility: Fountain Street General Practice
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Central Medical Centre
state: New South Wales
city: Port Macquarie
country: Australia
facility: CPC Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Adelaide
country: Australia
facility: Riverside Family Medical Practice
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
city: Melbourne
country: Australia
facility: Northside Clinic
state: Victoria
city: Melbourne
country: Australia
facility: Richmond Hill Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Recreation Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: Melbourne
country: Australia
facility: Centre Clinic
state: Victoria
Study officials:
affiliation: Monash University
name: Julian Elliott
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.