An interventional study of Integrated self management support in HIV and Cardiovascular Disease, sponsored by Karen Klassen. Completed at 14 sites in Australia. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Karen Klassen · Not applicable, Interventional, and Prevention
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 731 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →This is the only study on the registry with Karen Klassen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
•HIV infected adults aged 30 years or over.
Exclusion Criteria:
•Diagnosed cardiovascular disease, consisting of coronary heart disease, stroke or transient ischaemia attack, or peripheral arterial disease.
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 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.
The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
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.
Time frame: 12 months
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
(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.)
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
(measured by serum assay)
Time frame: 12 months
Systolic blood pressure
(using a sphygmomanometer)
Time frame: 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)
Time frame: 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/)
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
(Below the lower limit of detection of the assay used )
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)
using a questionnaire designed specifically for this study and using structured interviews.
Time frame: 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.
Time frame: 12 months
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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