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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178930
• Other study ID #: U1111-1150-6489
• Status: Completed
• Phase: N/A
• First received: June 29, 2014
• Last updated: August 28, 2017
• Start date: August 1, 2014
• Est. completion date: April 30, 2017

Study information

• Verified date: August 2017
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: April 30, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• HIV

Intervention

Other:
• Integrated self management support
The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.

Locations

Country	Name	City	State
Australia	Riverside Family Medical Practice	Adelaide	South Australia
Australia	Fountain Street General Practice	Alexandra	New South Wales
Australia	Coffs Central Medical Centre	Coffs Harbour	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Centre Clinic	Melbourne	Victoria
Australia	Melbourne Sexual Health Centre	Melbourne	Victoria
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Northside Clinic	Melbourne	Victoria
Australia	Prahran Market Clinic	Melbourne	Victoria
Australia	Recreation Medical Centre	Melbourne	Victoria
Australia	Richmond Hill Medical Centre	Melbourne	Victoria
Australia	CPC Medical Practice	Port Macquarie	New South Wales
Australia	East Sydney Doctors	Sydney	New South Wales
Australia	Holdsworth House Medical Practice	Sydney	New South Wales

Sponsors (13)

Lead Sponsor

Collaborator

Karen Klassen

Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine, Deakin University, Department of Health & Human Services, State Government of Victoria, Australia, Flinders University, Living Positive Victoria, Monash University, National Association of People with HIV Australia, National Health and Medical Research Council, Australia, NSW Ministry of Health, The Alfred, University of Melbourne, Victorian AIDS Council

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables		12 months
Secondary	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
Secondary	Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study		12 months
Secondary	Fasting total cholesterol and total cholesterol:HDL ratio	(measured by serum assay)	12 months
Secondary	Systolic blood pressure	(using a sphygmomanometer)	12 months
Secondary	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
Secondary	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
Secondary	Quality of life as measured by the AQoL-4D instrument		12 months
Secondary	Mental health status as measured by the DASS instrument		12 months
Secondary	Self-management capacity as measured by the heiQ instrument		12 months
Secondary	Proportion of patients with HIV virological suppression	(Below the lower limit of detection of the assay used )	12 months
Secondary	Proportion of patients achieving HIV quality of care measures		12 months
Secondary	Evaluation of the intervention program (intervention arm only)	using a questionnaire designed specifically for this study and using structured interviews.	12 months
Secondary	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