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Trial registered on ANZCTR


Registration number
ACTRN12613000715774
Ethics application status
Approved
Date submitted
20/06/2013
Date registered
28/06/2013
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a patient-focussed electronic health system for reducing heart disease risk in people with cardiovascular disease.
Scientific title
A randomised controlled trial of a consumer focussed e-health strategy for cardiovascular risk management in General Practice and Aboriginal Community Controlled Health Services.
Secondary ID [1] 282712 0
Nil
Universal Trial Number (UTN)
Trial acronym
CONNECT (Consumer Navigation of electronic cardiovascular Tools)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 289426 0
Condition category
Condition code
Cardiovascular 289759 289759 0 0
Coronary heart disease
Public Health 289798 289798 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in the CONNECT programme which is a focused e-health strategy to assist with the management and prevention of CVD. Programme components focus on cardiovascular risk assessment, medication adherence, lifestyle change and seamless patient-provider communication. The CONNECT programme builds on a large program of work to develop a clinical decision support system for use in CVD risk management in primary care. We have previously built an electronic patient care system termed HealthTracker. This system is integrated with the primary health care electronic health record and provides: (1) point of care decision support related to CVD prevention and management; (2) a computerised audit tool that provides rapid snapshots on health service performance combined with a recall and reminder system; and (3) access to a quality improvement web-based portal where health services can view monthly peer-ranked performance and access tools and resources to support quality care. CONNECT is essentially a consumer focussed e-health companion HealthTracker. CONNECT will be available to participants for up to 12 months and they will be free to use the programme at their discretion. Participants will be asked to keep a diary of their usage and we will monitor usage monthly via analytic software (eg, number and frequency of logins, duration of interaction and system components utilised). CONNECT was systematically developed through an iterative process and using user-centred design approach [Fogg 2003]. This process includes collaborative design workshops (including journey mapping and persona building), sketching and iterative validation by consumers. The portal will be accessible via the internet and also via a downloadable application for use on a mobile device. Within the portal, users will be able to interact with four key features: (1) their personal health record summary (e.g. diagnoses, current medications, , latest blood pressure, weight, cholesterol results); (2) interactive tools and resources (eg. the HealthTracker ‘heart age’ calculator that visually plots CVD risk projections and allows people to perform ‘what if scenarios’ to explore the relative risk reductions from various CVD risk factors); (3) motivational message prompts depending on their health profile (e.g. smokers wanting to quit will be able to receive a series of random messages over a 6 month period to assist with cessation); and (4) goal setting with virtual positive reinforcement.
Intervention code [1] 287373 0
Lifestyle
Intervention code [2] 287406 0
Prevention
Intervention code [3] 287407 0
Treatment: Other
Comparator / control treatment
The control group will participate in standard care and will not have access to the CONNECT consumer portal, however, at the end of study (after an average of 12 months) all participants (control and intervention) will be offered portal access for a minimum of 12 months. Standard care will include any strategies initiated and implemented by the participants primary care physician during the course of the study. We will capture information about participation in preventive care strategies at the final assessment as part of our process analysis.
Control group
Active

Outcomes
Primary outcome [1] 289843 0
The primary endpoint will be the proportion of days covered with guideline recommended medications. This will be defined based on the proportion of maximum medication dispensed from pharmacy using Pharmaceutical Benefits Scheme dispensing data. The primary outcome will be met if at end of study >=80% of maximum medication has been dispensed in the previous 12 months of at least one blood pressure (BP)-lowering medication AND one statin medication.
Timepoint [1] 289843 0
End of study (average of 12 months)
Secondary outcome [1] 303370 0
BMI and waist circumference – measured by researcher blinded to treatment allocation
Timepoint [1] 303370 0
End of study (average of 12 months)
Secondary outcome [2] 303448 0
Physical activity – WHO Global Physical Activity Questionnaire
Timepoint [2] 303448 0
End of study (average of 12 months)
Secondary outcome [3] 303449 0
Hospital readmissions (all cause) - self report and medical record review
Timepoint [3] 303449 0
End of study (average of 12 months)
Secondary outcome [4] 303450 0
Smoking rate, quitting attempts – self report, carbon monoxide meter
Timepoint [4] 303450 0
End of study (average of 12 months)
Secondary outcome [5] 303451 0
Fruit/ vegetable intake – self-report of portions consumed in prior seven days.
Timepoint [5] 303451 0
End of study (average of 12 months)
Secondary outcome [6] 303452 0
Quality of life – EQ5D
Timepoint [6] 303452 0
End of study (average of 12 months)
Secondary outcome [7] 303453 0
Cardioprotective medication use – self-report
Timepoint [7] 303453 0
End of study (average of 12 months)
Secondary outcome [8] 303455 0
Health Literacy using the Health Literacy Questionnaire and eHEALS scale.
Timepoint [8] 303455 0
End of study (average of 12 months)
Secondary outcome [9] 304411 0
Change in mean total cholesterol from baseline fasting blood sample
Timepoint [9] 304411 0
End of study (average of 12 months)
Secondary outcome [10] 314937 0
Change in mean systolic blood pressure from baseline measures – average of 3 resting, sitting digital recordings, mean of last two readings.
Timepoint [10] 314937 0
End of study (average of 12 months)
Secondary outcome [11] 314938 0
Change in mean fasting low density lipoprotein (LDL) cholesterol from baseline measures - fasting blood sample
Timepoint [11] 314938 0
End of study (average of 12 months)
Secondary outcome [12] 347084 0
A composite of the proportion of participants at end of study whose BP AND fasting low density lipoprotein (LDL) cholesterol are meeting Australian guideline targets (defined as: less than or equal to 130/80mmHg for CVD, Diabetes or albuminuria or less than or equal to 140/90mmHg for all others, AND LDL-cholesterol < 2.0mmol/L).
Timepoint [12] 347084 0
12 months

Eligibility
Key inclusion criteria
Consenting adult patients (>18 years) with access to the internet at least once a month via mobile phone, tablet or computer who are at moderate to high risk of a CVD event. Moderate-high CVD risk is defined as any of the following:
1. Five year CVD risk great then or equal to 10% using the Framingham risk equation;
2. A clinically high risk condition (diabetes and age>60 years, diabetes and albuminuria, eGFR<45ml/min, systolic BP >180mmHg, diastolic BP >110mmHg, total cholesterol > 7.5mmol/L);
3. An established CVD diagnosis (ischaemic heart disease, stroke/TIA, peripheral vascular disease).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to speak sufficient English to provide written and informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible consenting participants will be randomly assigned to the e-health strategy or provision of usual care for an average of 12 months. In both groups, any advice and/or other interventions provided by the GP/health service will continue at their discretion. Study personnel taking follow-up assessments will also be blinded to parallel group assignments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be fully blinded and conducted through the George Institute’s central, computer-based randomisation service. Allocation will be 1:1 intervention vs control using a permuted block sequence, stratified by study site, level of CVD risk, and Aboriginal and/or Torres Strait Islander status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analyses will be unadjusted, following an intention to treat principle and conducted blind to treatment allocation. If necessary, multivariate analyses will be performed to adjust for any significant differences between each study arm. Mean risk factor levels will be compared between groups in terms of relative risks, 95% CIs and two-sided p values. Characteristics will be compared between groups using independent t tests for continuous or chi-squared tests for categorical variables. Mann-Whitney U tests will be used where data are not normally distributed. All statistical analyses will be conducted blinded to intervention allocation. For the primary outcome measure, sample size considerations have been determined from TORPEDO data for 10,181 routinely attending patients at moderate to high CVD risk. Calculations assume that 25% of people are meeting guideline recommended BP and LDL targets (as defined above), a mean systolic BP 136mmHg (SD 17.2) and mean LDL cholesterol 2.5mmol (SD 0.70). A total sample size of 2000 participants, allowing for a 20% loss to follow-up would have 90% power to detect an absolute improvement of at least 7.5% in the proportion of people meeting recommended targets using two-sided tests, with p values of less than 0.05 judged as significant. For secondary outcomes this translates to a 2.8mmHg absolute difference in systolic BP and a 0.11mmol/L absolute difference in LDL cholesterol.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
17/10/2014
Date of last participant enrolment
Anticipated
Actual
5/05/2017
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
2000
Accrual to date
Final
934
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287483 0
Government body
Name [1] 287483 0
National Health and Medical Research Council (NHMRC) Project grant (ID 1047508).
Country [1] 287483 0
Australia
Funding source category [2] 287484 0
Charities/Societies/Foundations
Name [2] 287484 0
HCF Foundation
Country [2] 287484 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The George Institute for Global Health
Address
Level 3, 50 Bridge St, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 286225 0
University
Name [1] 286225 0
The University of Sydney
Address [1] 286225 0
The University of Sydney, NSW 2006
Country [1] 286225 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289461 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 289461 0
Ethics committee country [1] 289461 0
Australia
Date submitted for ethics approval [1] 289461 0
22/07/2013
Approval date [1] 289461 0
30/08/2013
Ethics approval number [1] 289461 0
2013/716
Ethics committee name [2] 292916 0
Department of Health Human Research Ethics Committee
Ethics committee address [2] 292916 0
Ethics committee country [2] 292916 0
Australia
Date submitted for ethics approval [2] 292916 0
26/02/2014
Approval date [2] 292916 0
15/04/2014
Ethics approval number [2] 292916 0
16/2014
Ethics committee name [3] 292917 0
Aboriginal Health and Medical Research Council
Ethics committee address [3] 292917 0
Ethics committee country [3] 292917 0
Australia
Date submitted for ethics approval [3] 292917 0
22/07/2013
Approval date [3] 292917 0
26/09/2013
Ethics approval number [3] 292917 0
959/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40942 0
A/Prof Julie Redfern
Address 40942 0
A/Professor Julie Redfern, The George Institute for Global Health,
Level 10, King George V Building, Missenden Road, Camperdown NSW 2050.
Country 40942 0
Australia
Phone 40942 0
+61299934574
Fax 40942 0
Email 40942 0
[email protected]
Contact person for public queries
Name 40943 0
Genevieve Coorey
Address 40943 0
Genevieve Coorey, The George Institute for Global Health,
Level 10, King George V Building, Missenden Road, Camperdown NSW 2050.
Country 40943 0
Australia
Phone 40943 0
+61280524644
Fax 40943 0
Email 40943 0
[email protected]
Contact person for scientific queries
Name 40944 0
Julie Redfern
Address 40944 0
A/Professor Julie Redfern, The George Institute for Global Health,
Level 10, King George V Building, Missenden Road, Camperdown NSW 2050.
Country 40944 0
Australia
Phone 40944 0
+61299934574
Fax 40944 0
Email 40944 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDevelopment of an integrated e-health tool for people with, or at high risk of, cardiovascular disease: The Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) web application.2016https://dx.doi.org/10.1016/j.ijmedinf.2016.01.009
EmbaseRisk scoring for the primary prevention of cardiovascular disease.2017https://dx.doi.org/10.1002/14651858.CD006887.pub4
EmbaseMobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.2018https://dx.doi.org/10.1002/14651858.CD012675.pub2
EmbaseA digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial.2020https://dx.doi.org/10.1038/s41746-020-00325-z
EmbaseAn internet-based intervention for cardiovascular disease management integrated with primary care electronic health records: Mixed methods evaluation of implementation fidelity and user engagement.2021https://dx.doi.org/10.2196/25333
N.B. These documents automatically identified may not have been verified by the study sponsor.