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

NCT02178930 | Completed

• 1 other identifier: U1111-1150-6489
• Study Type: interventional
• Target: 731
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

HIV; Cardiovascular Disease

Keywords

HIV; cardiovascular disease; self-management; HIV co-morbidities; self-efficacy; coronary heart disease risk; quality of life

Outcome Measures

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

  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 Outcomes (14)

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

  12 months

• Cardiovascular risk as estimated by an HIV-specific risk score

  12 months

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

  12 months

• Fasting total cholesterol and total cholesterol:HDL ratio

  12 months

• Systolic blood pressure

  12 months

Study Arms (2)

Integrated self management support

OTHER

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

Usual care

NO INTERVENTION

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.

Interventions

Integrated self management support OTHER

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

Integrated self management support

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (14)

Fountain Street General Practice

Alexandra, New South Wales, 2015, Australia

Location

Coffs Central Medical Centre

Coffs Harbour, New South Wales, 2450, Australia

Location

CPC Medical Practice

Port Macquarie, New South Wales, 2444, Australia

Location

East Sydney Doctors

Sydney, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Riverside Family Medical Practice

Adelaide, South Australia, 5042, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

Location

Northside Clinic

Melbourne, Victoria, 3068, Australia

Location

Richmond Hill Medical Centre

Melbourne, Victoria, 3121, Australia

Location

Recreation Medical Centre

Melbourne, Victoria, 3143, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Prahran Market Clinic

Melbourne, Victoria, 3181, Australia

Location

Centre Clinic

Melbourne, Victoria, 3182, Australia

Location

Related Publications (1)

• Dodson S, Klassen KM, McDonald K, Millard T, Osborne RH, Battersby MW, Fairley CK, Simpson JA, Lorgelly P, Tonkin A, Roney J, Slavin S, Sterjovski J, Brereton M, Lewin SR, Crooks L, Watson J, Kidd MR, Williams I, Elliott JH. HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV. BMC Infect Dis. 2016 Mar 5;16:114. doi: 10.1186/s12879-016-1422-5.

  PMID: 26945746 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Julian Elliott

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: June 29, 2014
• First Posted: July 1, 2014
• Study Start: August 1, 2014
• Primary Completion: March 31, 2017
• Study Completion: April 30, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

AU (14)