HealthMap: an Interactive Health Plan Randomised Trial to Prevent Cardiovascular Disease in People With HIV
- Conditions
- HIVCardiovascular Disease
- Interventions
- Other: Integrated self management support
- Registration Number
- NCT02178930
- Lead Sponsor
- Karen Klassen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 731
-
•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.
-
•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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Integrated self management support 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.
- Primary Outcome Measures
Name Time Method 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 12 months 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.
- Secondary Outcome Measures
Name Time Method Proportion of patients achieving HIV quality of care measures 12 months 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 12 months (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.)
Fasting total cholesterol and total cholesterol:HDL ratio 12 months (measured by serum assay)
Systolic blood pressure 12 months (using a sphygmomanometer)
Proportion of patients achieving Australian cardiovascular risk factor management targets 12 months (http://strokefoundation.com.au/healthprofessionals/ clinical-guidelines/guidelines-for-the-assessment-andmanagement- of-absolute-cvd-risk/)
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 Body mass index and waist circumference 12 months 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)
Proportion of patients with HIV virological suppression 12 months (Below the lower limit of detection of the assay used )
Evaluation of the intervention program (intervention arm only) 12 months using a questionnaire designed specifically for this study and using structured interviews.
Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study 12 months Health care provider related: Evaluation of the intervention program intervention arm only) 12 months Evaluation of the intervention program (intervention arm only) using a questionnaire designed specifically for this study and using structured interviews.
Trial Locations
- Locations (14)
Fountain Street General Practice
🇦🇺Alexandra, New South Wales, Australia
CPC Medical Practice
🇦🇺Port Macquarie, New South Wales, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Northside Clinic
🇦🇺Melbourne, Victoria, Australia
Centre Clinic
🇦🇺Melbourne, Victoria, Australia
Melbourne Sexual Health Centre
🇦🇺Melbourne, Victoria, Australia
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia
Prahran Market Clinic
🇦🇺Melbourne, Victoria, Australia
East Sydney Doctors
🇦🇺Sydney, New South Wales, Australia
Holdsworth House Medical Practice
🇦🇺Sydney, New South Wales, Australia
Riverside Family Medical Practice
🇦🇺Adelaide, South Australia, Australia
Coffs Central Medical Centre
🇦🇺Coffs Harbour, New South Wales, Australia
Richmond Hill Medical Centre
🇦🇺Melbourne, Victoria, Australia
Recreation Medical Centre
🇦🇺Melbourne, Victoria, Australia