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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Monash University
Sponsor:
Collaborators:
Alfred Health
Monash University
Australasian Society for HIV Medicine
National Association for People with HIV Australia
National Health and Medical Research Council, Australia
Victorian AIDS Council
Department of Health, Victoria
Flinders University
Living Positive Victoria
New South Wales 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: June 30, 2014
Last verified: June 2014
  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 clinic-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 ]

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 ]
  • 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 ]
  • Systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Body mass index and waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients achieving Australian cardiovascular risk factor management targets [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
  • Health care provider related: Number of annual health care plans (including GP Management Plans and Team Care Arrangements) developed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health care provider related: Evaluation of the intervention program intervention arm only) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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.
Placebo Comparator: 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
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

Contacts
Contact: Karen Klassen +6139068486 karen.klassen@monash.edu

Locations
Australia, New South Wales
Fountain Street General Practice Not yet recruiting
Alexandra, New South Wales, Australia, 2015
Contact    61296991491    bradley@fountaingp.com   
Principal Investigator: Bradley Forssman         
Coffs Central Medical Centre Not yet recruiting
Coffs Harbour, New South Wales, Australia, 2450
Contact: David Elliss    61266528699      
Principal Investigator: David Ellis         
CPC Medical Practice Not yet recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Trina Gregory    61265832008      
Principal Investigator: Trina Gregory         
East Sydney Doctors Not yet recruiting
Sydney, New South Wales, Australia, 2010
Contact: David Baker    61293322531      
Principal Investigator: David Baker         
Holdsworth House Medical Practice Not yet recruiting
Sydney, New South Wales, Australia, 2010
Contact: Shikha Agrawal    61293316228      
Principal Investigator: Mark Bloch         
Sub-Investigator: Shikha Agrawal         
Australia, South Australia
Riverside Family Medical Practice Not yet recruiting
Adelaide, South Australia, Australia, 5042
Contact: Sam Elliott    61882774399      
Principal Investigator: Sam Elliott         
Australia, Victoria
Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Janine Roney    61390762296      
Sub-Investigator: James McMahon         
Centre Clinic Not yet recruiting
Melbourne, Victoria, Australia, 3182
Contact: Helen Lau    61395255866      
Principal Investigator: Ban Kiem Tee         
Melbourne Sexual Health Centre Not yet recruiting
Melbourne, Victoria, Australia, 3053
Contact: Julie Silvers    61393416200      
Principal Investigator: Christopher Fairley         
Sub-Investigator: Julie Silvers         
Monash Medical Centre Not yet recruiting
Melbourne, Victoria, Australia, 3168
Contact: Ian Woolley    61395944564      
Principal Investigator: Ian Woolley         
Northside Clinic Not yet recruiting
Melbourne, Victoria, Australia, 3068
Contact: Rachel Woolstencroft    61394857700      
Principal Investigator: Richard Moore         
Sub-Investigator: Rachel Woolstencroft         
Sub-Investigator: Sian Edwards         
Prahran Market Clinic Not yet recruiting
Melbourne, Victoria, Australia, 3181
Contact: Helen Lau    61395140888      
Principal Investigator: Norman Roth         
Sub-Investigator: Helen Lau         
Recreation Medical Centre Not yet recruiting
Melbourne, Victoria, Australia, 3143
Contact: Mark Choong    61395095922      
Principal Investigator: Mark Choong         
Richmond Hill Medical Centre Not yet recruiting
Melbourne, Victoria, Australia, 3121
Contact: Richard Wright    61394284148      
Principal Investigator: Richard Wright         
Sponsors and Collaborators
Karen Klassen
Alfred Health
Monash University
Australasian Society for HIV Medicine
National Association for People with HIV Australia
National Health and Medical Research Council, Australia
Victorian AIDS Council
Department of Health, Victoria
Flinders University
Living Positive Victoria
New South Wales Ministry of Health
University of Melbourne
Deakin University
Investigators
Principal Investigator: Julian Elliott Monash University
  More Information

No publications provided

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: June 30, 2014
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 July 20, 2014