Cardiovascular Disease, HIV
Conditions
Keywords
HIV, cardiovascular disease, self-management, HIV co-morbidities, self-efficacy, coronary heart disease risk, quality of life
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.
Interventions
OTHERIntegrated self management support
The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
Sponsors
The Alfred
Monash University
Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine
National Association of People with HIV Australia
National Health and Medical Research Council, Australia
Victorian AIDS Council
Department of Health & Human Services, State Government of Victoria, Australia
Flinders University
Living Positive Victoria
NSW Ministry of Health
University of Melbourne
Deakin University
Karen Klassen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Fasting total cholesterol and total cholesterol:HDL ratio | 12 months | (measured by serum assay) |
| Systolic blood pressure | 12 months | (using a sphygmomanometer) |
| 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.) |
| 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 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/) |
| Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study | 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 | 12 months | (Below the lower limit of detection of the assay used ) |
| Proportion of patients achieving HIV quality of care measures | 12 months | — |
| Evaluation of the intervention program (intervention arm only) | 12 months | using a questionnaire designed specifically for this study and using structured interviews. |
| 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. |
| Quality of life as measured by the AQoL-4D instrument | 12 months | — |
Countries
Australia
Outcome results
None listed