Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000739415p
Ethics application status
Submitted, not yet approved
Date submitted
24/06/2025
Date registered
11/07/2025
Date last updated
11/07/2025
Date data sharing statement initially provided
11/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
SMART-AF: Support, Monitoring, and AI-Driven Resources with Training & Education for Atrial Fibrillation: a randomized controlled trial
Scientific title
SMART-AF: Support, Monitoring, and AI-Driven Resources with Training & Education in Atrial Fibrillation: a randomized controlled trial to evaluate the effect on knowledge in adults with Atrial Fibrillation
Secondary ID [1] 314612 0
None
Universal Trial Number (UTN)
Trial acronym
SMART-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 337746 0
Condition category
Condition code
Cardiovascular 334075 334075 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves access to an online platform (HelloAlfred.ai) for a duration of 12 weeks. Participants will be given access to the website through unique usernames and temporary passwords, generated upon registration of the single patient onto the platform by study investigators.

The platform includes:
a) A structured 12-module educational program focused on atrial fibrillation (AF), developed and validated by a team of clinicians in accordance with current international guidelines (especially ACC/HRS/AHA and ESC guidelines for diagnosis and management of atrial fibrillation).
These modules cover key topics related to AF, including causes, symptoms, importance of risk factors and lifestyle modification, stroke prevention, rate and rhythm control medications, cardioversion, catheter ablation, and long-term management.
Education is delivered mainly through written materials and short animations and is reinforced after each module through brief 3-question quizzes. Each module five to fifteen minutes to read thoroughly.

b) An AI-powered conversational chatbot designed to respond to users’ questions about AF. The chatbot provides evidence-based information by retrieving content from peer-reviewed, clinically validated documents uploaded to the platform. Study investigators will review responses at least once weekly to ensure that interactions are accurate.

All content is delivered digitally, and participants can access the materials at their convenience throughout the 12-week intervention period. App analytics will be available to study investigators to monitor adherence to intervention, thanks to special admin rights within the website itself,
Intervention code [1] 331238 0
Behaviour
Intervention code [2] 331239 0
Treatment: Other
Comparator / control treatment
The control group will receive care with their physician as per usual care pathways. These include periodic visits with the referring cardiologist and additional assessments when deemed necessary.
Patients will undergo the same assessments but will not receive access to the platform.
Control group
Active

Outcomes
Primary outcome [1] 341737 0
Atrial fibrillation related knowledge
Timepoint [1] 341737 0
Baseline and 12 weeks after randomization
Secondary outcome [1] 448567 0
Self-reported lifestyle modifications
Timepoint [1] 448567 0
Baseline and 12 weeks after randomization
Secondary outcome [2] 448568 0
Anxiety
Timepoint [2] 448568 0
Baseline and 12 weeks after randomization
Secondary outcome [3] 448569 0
Atrial fibrillation related symptoms
Timepoint [3] 448569 0
Baseline and 12 weeks after randomization
Secondary outcome [4] 448570 0
Atrial fibrillation related quality of live
Timepoint [4] 448570 0
Baseline and 12 weeks after randomization
Secondary outcome [5] 449407 0
Depression
Timepoint [5] 449407 0
Baseline and 12 weeks after randomization

Eligibility
Key inclusion criteria
- All patients with newly diagnosed atrial fibrillation
- Able and willing to give informed consent.
- Able to speak, write and read English with varied literacy levels.
- Able to type and use an electronic device (phone, app, computer/laptop)
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient unwilling to participate.
- No internet access or unable to use electronic devices.
- Severe co existing comorbidities (advanced heart failure with NYHA class IV, end stage renal disease and/or on dialysis, acute stroke).
- Patients with cognitive impairment that would limit their ability to interact with the educational curriculum or AI bot
- Visual/auditory impairment that would prevent their interactions with the platform

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Categorical variables expressed as a percentage, continuous variables expressed as mean +/- SD and skewed data as median (interquartile range [IQR]). P value <0.05 for significance. Comparative analysis to measure changes in knowledge and quality of life pre- and post-intervention. Thematic analysis for qualitative data to identify key themes and areas for improvement.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319171 0
University
Name [1] 319171 0
Centre of Heart Rhythm Disorders - University of Adelaide
Country [1] 319171 0
Australia
Primary sponsor type
University
Name
Centre of Heart Rhythm Disorders - University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 321636 0
None
Name [1] 321636 0
Address [1] 321636 0
Country [1] 321636 0
Other collaborator category [1] 283544 0
Commercial sector/Industry
Name [1] 283544 0
HelloAlfred.ai
Address [1] 283544 0
Country [1] 283544 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317756 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 317756 0
Ethics committee country [1] 317756 0
Australia
Date submitted for ethics approval [1] 317756 0
12/05/2025
Approval date [1] 317756 0
Ethics approval number [1] 317756 0

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

Contacts
Principal investigator
Name 142030 0
Prof Prashanthan Sanders
Address 142030 0
University of Adelaide, North Terrace, SA 5000, Australia
Country 142030 0
Australia
Phone 142030 0
+61 8 8313 9000
Fax 142030 0
Email 142030 0
[email protected]
Contact person for public queries
Name 142031 0
Alessandra Pina
Address 142031 0
University of Adelaide, North Terrace, SA 5000, Australia
Country 142031 0
Australia
Phone 142031 0
+61 0425443454
Fax 142031 0
Email 142031 0
[email protected]
Contact person for scientific queries
Name 142032 0
Prashanthan Sanders
Address 142032 0
University of Adelaide, North Terrace, SA 5000, Australia
Country 142032 0
Australia
Phone 142032 0
+61 8 8313 9000
Fax 142032 0
Email 142032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.