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

Sponsor

Karen Klassen (Other)

Overall Status

Completed

CT.gov ID

NCT02178930

Collaborator

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

731

Enrollment

Locations

Arms

Actual Duration (Months)

52.2

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Cardiovascular Disease	Other: Integrated self management support	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

731 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Mar 31, 2017

Actual Study Completion Date :

Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

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 [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 Outcome Measures

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]
(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 [12 months]
Fasting total cholesterol and total cholesterol:HDL ratio [12 months]
(measured by serum assay)
Systolic blood pressure [12 months]
(using a sphygmomanometer)
Body mass index and waist circumference [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)
Proportion of patients achieving Australian cardiovascular risk factor management targets [12 months]
(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 [12 months]
Mental health status as measured by the DASS instrument [12 months]
Self-management capacity as measured by the heiQ instrument [12 months]
Proportion of patients with HIV virological suppression [12 months]
(Below the lower limit of detection of the assay used )
Proportion of patients achieving HIV quality of care measures [12 months]
Evaluation of the intervention program (intervention arm only) [12 months]
using a questionnaire designed specifically for this study and using structured interviews.
Health care provider related: Evaluation of the intervention program intervention arm only) [12 months]
Evaluation of the intervention program (intervention arm only) using a questionnaire designed specifically for this study and using structured interviews.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Fountain Street General Practice	Alexandra	New South Wales	Australia	2015
2	Coffs Central Medical Centre	Coffs Harbour	New South Wales	Australia	2450
3	CPC Medical Practice	Port Macquarie	New South Wales	Australia	2444
4	East Sydney Doctors	Sydney	New South Wales	Australia	2010
5	Holdsworth House Medical Practice	Sydney	New South Wales	Australia	2010
6	Riverside Family Medical Practice	Adelaide	South Australia	Australia	5042
7	Alfred Hospital	Melbourne	Victoria	Australia	3004
8	Melbourne Sexual Health Centre	Melbourne	Victoria	Australia	3053
9	Northside Clinic	Melbourne	Victoria	Australia	3068
10	Richmond Hill Medical Centre	Melbourne	Victoria	Australia	3121
11	Recreation Medical Centre	Melbourne	Victoria	Australia	3143
12	Monash Medical Centre	Melbourne	Victoria	Australia	3168
13	Prahran Market Clinic	Melbourne	Victoria	Australia	3181
14	Centre Clinic	Melbourne	Victoria	Australia	3182