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Completed

NCT Number: NCT02178930

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

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.

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Key information

Conditions

HIV Cardiovascular Disease Cardiovascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fountain Street General Practice, Alexandra, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated self management support

Other

The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables

    Time frame: 12 months

  2. Cardiovascular risk as estimated by an HIV-specific risk score

    Time frame: 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.)

  3. Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study

    Time frame: 12 months

  4. Fasting total cholesterol and total cholesterol:HDL ratio

    Time frame: 12 months

    (measured by serum assay)

  5. Systolic blood pressure

    Time frame: 12 months

    (using a sphygmomanometer)

  6. Body mass index and waist circumference

    Time frame: 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)

  7. Proportion of patients achieving Australian cardiovascular risk factor management targets

    Time frame: 12 months

    (http://strokefoundation.com.au/healthprofessionals/ clinical-guidelines/guidelines-for-the-assessment-andmanagement- of-absolute-cvd-risk/)

  8. Quality of life as measured by the AQoL-4D instrument

    Time frame: 12 months

  9. Mental health status as measured by the DASS instrument

    Time frame: 12 months

  10. Self-management capacity as measured by the heiQ instrument

    Time frame: 12 months

  11. Proportion of patients with HIV virological suppression

    Time frame: 12 months

    (Below the lower limit of detection of the assay used )

  12. Proportion of patients achieving HIV quality of care measures

    Time frame: 12 months

  13. Evaluation of the intervention program (intervention arm only)

    Time frame: 12 months

    using a questionnaire designed specifically for this study and using structured interviews.

  14. Health care provider related: Evaluation of the intervention program intervention arm only)

    Time frame: 12 months

    Evaluation of the intervention program (intervention arm only) using a questionnaire designed specifically for this study and using structured interviews.

Sponsors and collaborators

Lead sponsor

Karen Klassen

Other

Collaborators

  • 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
  • NSW Ministry of Health
  • National Association of People with HIV Australia
  • National Health and Medical Research Council, Australia
  • The Alfred
  • University of Melbourne
  • Victorian AIDS Council

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2014
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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