HIVNCT02178930
HealthMap: an Interactive Health Plan Randomised Trial to Prevent Cardiovascular Disease in People With HIV
A study testing Integrated self management support in people with HIV and Cardiovascular Disease, run by Karen Klassen at 14 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- HIV, Cardiovascular Disease
- What is being tested?
- Integrated self management support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 14 sitesAustralia
- Study dates
- 1 Aug 2014to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •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.
Who cannot join
- •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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Australia14 sites
Riverside Family Medical Practice
Adelaide, South Australia, 5042
Fountain Street General Practice
Alexandra, New South Wales, 2015
Coffs Central Medical Centre
Coffs Harbour, New South Wales, 2450
Alfred Hospital
Melbourne, Victoria, 3004
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053
Northside Clinic
Melbourne, Victoria, 3068
Richmond Hill Medical Centre
Melbourne, Victoria, 3121
Recreation Medical Centre
Melbourne, Victoria, 3143
Monash Medical Centre
Melbourne, Victoria, 3168
Prahran Market Clinic
Melbourne, Victoria, 3181
Centre Clinic
Melbourne, Victoria, 3182
CPC Medical Practice
Port Macquarie, New South Wales, 2444
East Sydney Doctors
Sydney, New South Wales, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
About this study
Official title: HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support 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:
Read more
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.
Read the 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.
- Conditions
- HIV, Cardiovascular Disease
- Being tested
- Integrated self management support
- Keywords
- HIV, cardiovascular disease, self-management, HIV co-morbidities, self-efficacy, coronary heart disease risk, quality of life
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated self management supportOther
The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (14)
Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables
Measured: 12 months
Cardiovascular risk as estimated by an HIV-specific risk score
(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.)
Measured: 12 months
Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study
Measured: 12 months
Fasting total cholesterol and total cholesterol:HDL ratio
(measured by serum assay)
Measured: 12 months
Systolic blood pressure
(using a sphygmomanometer)
Measured: 12 months
Body mass index and waist circumference
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)
Measured: 12 months
Proportion of patients achieving Australian cardiovascular risk factor management targets
(http://strokefoundation.com.au/healthprofessionals/ clinical-guidelines/guidelines-for-the-assessment-andmanagement- of-absolute-cvd-risk/)
Measured: 12 months
Quality of life as measured by the AQoL-4D instrument
Measured: 12 months
Mental health status as measured by the DASS instrument
Measured: 12 months
Self-management capacity as measured by the heiQ instrument
Measured: 12 months
Proportion of patients with HIV virological suppression
(Below the lower limit of detection of the assay used )
Measured: 12 months
Proportion of patients achieving HIV quality of care measures
Measured: 12 months
Evaluation of the intervention program (intervention arm only)
using a questionnaire designed specifically for this study and using structured interviews.
Measured: 12 months
Health care provider related: Evaluation of the intervention program intervention arm only)
Evaluation of the intervention program (intervention arm only) using a questionnaire designed specifically for this study and using structured interviews.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study start1 Aug 2014
- Primary completion31 Mar 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Klassen
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Karen Klassen, Monash University
- Investigators
- Julian Elliott, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178930
- Sponsor's protocol ID
- U1111-1150-6489
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2014
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26945746
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV
- ClinicalTrials.gov ID
- NCT02178930
- Acronym / sponsor ID
- U1111-1150-6489
- Conditions
- HIV, Cardiovascular Disease
- Keywords
- HIV, cardiovascular disease, self-management, HIV co-morbidities, self-efficacy, coronary heart disease risk, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Karen KlassenUniversity, hospital or other
- 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
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated self management support | Other | Other: Integrated self management supportThe 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. |
| 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- •HIV infected adults aged 30 years or over.
Key exclusion criteria (2 listed)
- •Diagnosed cardiovascular disease, consisting of coronary heart disease, stroke or transient ischaemia attack, or peripheral arterial disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated self management supportThe intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching. | Other | Integrated self management support |
Primary outcome
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.
14 secondary outcomes
Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables
Time frame: 12 months
Cardiovascular risk as estimated by an HIV-specific risk score
Time frame: 12 months
Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study
Time frame: 12 months
Fasting total cholesterol and total cholesterol:HDL ratio
Time frame: 12 months
Systolic blood pressure
Time frame: 12 months
Body mass index and waist circumference
Time frame: 12 months
Proportion of patients achieving Australian cardiovascular risk factor management targets
Time frame: 12 months
Quality of life as measured by the AQoL-4D instrument
Time frame: 12 months
Mental health status as measured by the DASS instrument
Time frame: 12 months
Self-management capacity as measured by the heiQ instrument
Time frame: 12 months
Proportion of patients with HIV virological suppression
Time frame: 12 months
Proportion of patients achieving HIV quality of care measures
Time frame: 12 months
Evaluation of the intervention program (intervention arm only)
Time frame: 12 months
Health care provider related: Evaluation of the intervention program intervention arm only)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 26945746Dodson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Elliott principal investigator
Monash University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated self management support in people with HIV and Cardiovascular Disease, run by Karen Klassen at 14 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.