Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001174572p
Ethics application status
Submitted, not yet approved
Date submitted
13/09/2024
Date registered
25/09/2024
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ePREVENT-360 Empowering Patients Enhancing PREVENTion
A feasibility study of a consumer-facing digital chronic disease prevention intervention in Australian general practices.
Scientific title
ePREVENT-360 – Empowering consumers. Enhancing PREVENTion.
A mixed methods pre- and post-intervention feasibility pilot study of a digital chronic condition prevention intervention in Australian general practice, assessing acceptability and engagement amongst consumers and clinicians.
Secondary ID [1] 312661 0
None
Universal Trial Number (UTN)
Trial acronym
ePREVENT-360
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventable chronic conditions 334911 0
Ischaemic heart disease 334913 0
Metabolic syndromes 334914 0
Bowel cancer 334915 0
Breast cancer 334916 0
Skin cancer - melanoma and non-melanomatous 334917 0
Lung cancer 334918 0
Hypertension 334919 0
Osteoporosis 334920 0
Glaucoma 334921 0
Obstructive sleep apnoea 334922 0
Condition category
Condition code
Public Health 331458 331458 0 0
Health promotion/education
Metabolic and Endocrine 331550 331550 0 0
Diabetes
Cardiovascular 331551 331551 0 0
Hypertension
Musculoskeletal 331706 331706 0 0
Osteoporosis
Cardiovascular 331707 331707 0 0
Coronary heart disease
Respiratory 331756 331756 0 0
Sleep apnoea
Eye 331757 331757 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves provision of access to digital chronic condition prevention intervention (IN2HEALTH) for six months. A digital link to the assessment will be provided via email once participants have provided informed consent and completed the pre-intervention online survey.

The intervention is self-administered and consists of an online assessment of 130 risk and protective factors for 21 chronic conditions, calculation of lifetime risk, provision of health scores on a dashboard and a personalised action plan with recommendations about lifestyle change and access to screening. The assessment takes on average 20-30 minutes to complete.

These lifetime risk calculations have been benchmarked against existing risk calculators and the recommendations are based on current Australian guidelines.

Participants will be encouraged to provide updates on any changes to their risk or protective factors every three months via the ’Pulse Check’, a brief online questionnaire. This takes 5-10 minutes to complete. Individuals are also encouraged to set SMART (Specific, Measurable, Achievable, Relevant and Time Bound) health goals through guidance provided in the Pulse Check and to receive supportive push notifications to encourage adherence to recommendations.

Consumer adherence to the recommendations are tracked over time via the 'Pulse Check' and as individuals update their health data or access screenings, their health scores are automatically recalculated, and an updated action plan is provided. Participants will also be encouraged to continue to engage with their own GP and/or practice nurse.

Engagement with the intervention will be measured through intervention usage logs measuring frequency and depth of use over the six month observation period.
Intervention code [1] 329368 0
Prevention
Intervention code [2] 329369 0
Early detection / Screening
Intervention code [3] 329370 0
Lifestyle
Comparator / control treatment
As this is a feasibility study there is no control group however individuals who opt not to engage with the intervention will be asked to participate in both a quantitative feedback survey and qualitative interviews to explore barriers to engagement.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339310 0
Engagement
Timepoint [1] 339310 0
Baseline, 3 and 6 months post-intervention introduction.
Secondary outcome [1] 439432 0
Acceptability
Timepoint [1] 439432 0
6 months post-intervention introduction.
Secondary outcome [2] 439433 0
Perceptions of sustainability
Timepoint [2] 439433 0
6 months post-intervention introduction.
Secondary outcome [3] 439435 0
Preliminary effectiveness: Self-rated health.
Timepoint [3] 439435 0
Baseline and 6 months post-intervention introduction.
Secondary outcome [4] 439844 0
Preliminary effectiveness: Consumer activation
Timepoint [4] 439844 0
Baseline and 6-months post-intervention introduction.
Secondary outcome [5] 439845 0
Preliminary effectiveness: Chronic disease risk scores
Timepoint [5] 439845 0
Baseline and 6-months post-intervention introduction

Eligibility
Key inclusion criteria
Consumer participants will be recruited from general practices that have agreed to participate in this project. As the main aim is to assess feasibility, convenience sampling will be used. As the digital intervention is currently only available in English, participants must be English-speaking and have regular access to a digital device such as a smartphone or computer.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculation:
The sample size calculation is based on the primary feasibility outcome measure of proportion of patients who demonstrate at least ‘low use’ of the intervention, that is who complete the initial chronic condition risk assessment. Given that this is a feasibility study, to make inferential statements, a confidence interval of 95% with a margin of error of 10% would be required.


The estimated proportion of consumers who consent to participate in the study who will initially engage with the intervention is proposed to be set at 50%. This should provide a balance between practicality and precision. To factor in the effect of clustering, the intracluster coefficient and number of clusters needs to be considered. Based on existing Australian research data the range of intra-cluster correlation coefficients in Australian general practice appears to be between 0.004121 and 0.059. An intra-cluster correlation coefficient (ICC) of 0.05 has been selected for this project as this is broadly used in Australian and Canadian general practice research.

The calculated design effect across 5 clinics is 1.95 and the total minimum sample size required to evaluate the primary outcome is 187 patients. From participants who initially engage with the intervention, a dropout rate of 15% over the six-month observation period will be factored into the sample size calculation. We will therefore aim to recruit a minimum sample size of 215 consumers, 43 per clinic.

Quantitative data analysis:
A combination of descriptive statistics and frequency analysis methods will be used, likely to include bivariate and multivariate analysis using multilevel logistic and linear regression, conducted using SPSS.

Qualitative data analysis:
A descriptive qualitative approach will be used, specifically the Braun and Clarke six-phased approach using NVIVO.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
7/04/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
215
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 317095 0
Charities/Societies/Foundations
Name [1] 317095 0
Royal Australian College of General Practitioners Foundation/HCF Research Foundation Grant
Country [1] 317095 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 319635 0
None
Name [1] 319635 0
Address [1] 319635 0
Country [1] 319635 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315844 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Social Science Human Research Ethics Committee
Ethics committee address [1] 315844 0
Ethics committee country [1] 315844 0
Australia
Date submitted for ethics approval [1] 315844 0
27/08/2024
Approval date [1] 315844 0
Ethics approval number [1] 315844 0

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

Contacts
Principal investigator
Name 135974 0
Dr Gillian Singleton
Address 135974 0
Building 29, room 315, School of Health and Society, University of Wollongong, NSW 2522
Country 135974 0
Australia
Phone 135974 0
+61 242215351
Fax 135974 0
Email 135974 0
[email protected]
Contact person for public queries
Name 135975 0
Gillian Singleton
Address 135975 0
Building 29, room 315, School of Health and Society, University of Wollongong, NSW 2522
Country 135975 0
Australia
Phone 135975 0
+61 242215351
Fax 135975 0
Email 135975 0
[email protected]
Contact person for scientific queries
Name 135976 0
Gillian Singleton
Address 135976 0
Building 29, room 315, School of Health and Society, University of Wollongong, NSW 2522
Country 135976 0
Australia
Phone 135976 0
+61 242215351
Fax 135976 0
Email 135976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study data will be de-identified prior to analysis and publication. No individual raw data will be published to ensure data confidentiality.


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
No additional documents have been identified.