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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Karen Klassen, Monash University
ClinicalTrials.gov Identifier:
NCT02178930
First received: June 29, 2014
Last updated: March 17, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
HIV
Cardiovascular Disease
Other: Integrated self management support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cardiovascular risk as estimated by an HIV-specific risk score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    (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.)

  • Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Fasting total cholesterol and total cholesterol:HDL ratio [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    (measured by serum assay)

  • Systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    (using a sphygmomanometer)

  • Body mass index and waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    (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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mental health status as measured by the DASS instrument [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Self-management capacity as measured by the heiQ instrument [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with HIV virological suppression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    (Below the lower limit of detection of the assay used )

  • Proportion of patients achieving HIV quality of care measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluation of the intervention program (intervention arm only) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    using a questionnaire designed specifically for this study and using structured interviews.

  • Health care provider related: Evaluation of the intervention program intervention arm only) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of the intervention program (intervention arm only) using a questionnaire designed specifically for this study and using structured interviews.


Enrollment: 731
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Integrated self management support
The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
No Intervention: Usual care
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.

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.
  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02178930

Locations
Australia, New South Wales
Fountain Street General Practice
Alexandra, New South Wales, Australia, 2015
Coffs Central Medical Centre
Coffs Harbour, New South Wales, Australia, 2450
CPC Medical Practice
Port Macquarie, New South Wales, Australia, 2444
East Sydney Doctors
Sydney, New South Wales, Australia, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
Australia, South Australia
Riverside Family Medical Practice
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Melbourne Sexual Health Centre
Melbourne, Victoria, Australia, 3053
Northside Clinic
Melbourne, Victoria, Australia, 3068
Richmond Hill Medical Centre
Melbourne, Victoria, Australia, 3121
Recreation Medical Centre
Melbourne, Victoria, Australia, 3143
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Prahran Market Clinic
Melbourne, Victoria, Australia, 3181
Centre Clinic
Melbourne, Victoria, Australia, 3182
Sponsors and Collaborators
Karen Klassen
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
Investigators
Principal Investigator: Julian Elliott Monash University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Klassen, Clinical Research Fellow, Monash University
ClinicalTrials.gov Identifier: NCT02178930     History of Changes
Other Study ID Numbers: U1111-1150-6489 
Study First Received: June 29, 2014
Last Updated: March 17, 2016
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Monash University:
HIV
cardiovascular disease
self-management
HIV co-morbidities
self-efficacy
coronary heart disease risk
quality of life

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016