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Trial registered on ANZCTR


Registration number
ACTRN12623000625673
Ethics application status
Approved
Date submitted
8/05/2023
Date registered
7/06/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
7/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
INFORM-AF II – A pilot randomised controlled trial of a digital atrial fibrillation (AF) education program for people living with AF.
Scientific title
INFORM-AF II – A pilot randomised controlled trial on the effect of a digital atrial fibrillation (AF) education program on re-hospitalisation rates in people living with AF.
Secondary ID [1] 309533 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
INFORM-AF II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrilation 329843 0
Condition category
Condition code
Cardiovascular 326780 326780 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The QStreamTM-based online learning module will comprise of 6 case-based AF learning scenarios. The key topic areas have been identified as priority areas for improvement from earlier research led by A/Prof Ferguson and the research team.

This novel intervention will combine: (a) authentic case-based anticoagulation learning scenarios; (b) real-time audit and feedback; and (c) online links to evidence-based learning materials. The intervention will be delivered directly to consenting participants’ smart phone. There will be two themes covered by the QStreamTM including ‘Understanding Atrial Fibrillation’ and ‘Managing Atrial Fibrillation’. This includes 6 topics, (1) AF symptoms, (2) AF risk factors, (3) AF complications, (4) Managing Medications, (5) Lifestyle Management and (6) Engaging with your health provider. Participants receive pop-up notifications (by default).

The INFORM-AF II module were developed by an interdisciplinary expert, clinicians who care for AF patients and patients with AF. The module includes unique case studies and answers to the case scenarios are informed and supported by the best evidence available in open access format to participants at the time of completing the module. An open access format will be selected to remove any paywall access barrier for participants to review the evidence base once completed.

Automated delivery of the 6 case scenarios by the QStreamTM platform will follow a standardised spaced algorithm: (a) two questions per delivery, every 2 days; b) questions answered incorrectly are repeated after 7 days, and questions answered correctly are repeated after 13 days; (c) two consecutive correct answers are required to retire a question, and a maximum of three attempts are provided before retiring a question. Cases will be retired once the participant correctly answers a question on two consecutive occasions.
Using the app may take approx. 5-10 minutes of the participants’ time, on every 2nd day of the week. The app is designed to be interactive and will provide users with some resources about your condition to read. Participants can read and interact with these resources at their leisure, this may take approx. 30 minutes to one hour of their time per week. It is expected that participation in the study will take no longer than 2 hours of participants time per week for a total of 6 weeks whilst using the app.

Participants will be able contact the research team via calling or email if there are any technical difficulties with the intervention during the 6-week intervention phase. They will also receive a follow-up phone call at 3 weeks during the intervention as a technical check-in only, and no questionnaires will be completed via the phone at this time.

Once participants have completed the learning module, which is anticipated to take 6 weeks to complete, they will receive follow-up phone calls from the study nurse at 6 weeks, 3, 6 and 12 months. Phone calls will last approx. 15 minutes in duration to deliver the battery of study outcome instruments (as outlined below) through the same electronic survey using REDCap (Research Electronic Data Capture) delivered at baseline.

The primary outcome is to measure re-hospitalisation as every hospital admission (including ED visits) occurring within 12 months of the baseline index admission, self-reported and confirmed by medical records for those admitted in the catchment hospitals. This will be recorded in a project-specific standardised case report form or entered directly into REDCap database developed by the study team.

Secondary outcomes include:

All-cause mortality as the death rate from all causes of death at 12 months, which will be recorded a project-specific standardised case report form or entered directly into a REDCap database developed by the study team.

Cardiovascular-related hospital admission including admissions related to AF, HF, thromboembolic events, bleeding events, peripheral or coronary events or other cardiovascular events, which will be recorded a project-specific standardised case report form or entered directly into a REDCap database developed by the study team.
Medication adherence which will be measured using the Modified Medication Adherence Rating Scale.

AF-specific knowledge which will be assessed using the Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ).

AF-specific quality of life which will be assessed using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire.

The study outcome instruments used in this study include the Modified Medication Adherence Rating Scale, the Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ), and the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT).
Intervention code [1] 325996 0
Behaviour
Intervention code [2] 326014 0
Prevention
Intervention code [3] 326119 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will receive the Stroke Foundation ‘Living with AF’ booklet.
Adherence to the comparator treatment will not be monitored.
Control group
Active

Outcomes
Primary outcome [1] 334607 0
To evaluate the effectiveness of a novel, co-designed digital AF education program delivered via QStream™ on re-hospitalisation rates (as every hospital admission including ED visits occurring within 12 months of the baseline index admission, self-reported and confirmed by medical records for those admitted in the catchment hospitals.)
Timepoint [1] 334607 0
12 months post-intervention commencement
Secondary outcome [1] 421394 0
To assess the effect of the QStream™ intervention on all-cause mortality (as the death rate from all causes of death at 12 months.)
Timepoint [1] 421394 0
12 months post-intervention commencement
Secondary outcome [2] 421395 0
Cardiovascular-related hospitalisations including admissions related to AF, HF, thromboembolic events, bleeding events, peripheral or coronary events or other cardiovascular events. This will be recorded as every hospital admission (including ED visits) occurring within 12 months of the baseline index admission, self-reported and confirmed by medical records for those admitted in the catchment hospitals. This will be recorded in a project-specific standardised case report form or entered directly into REDCap database developed by the study team.
Timepoint [2] 421395 0
6 weeks, 3 months, 6 months and 12 months post-intervention commencement
Secondary outcome [3] 421396 0
To evaluate the effectiveness of the QStream™ intervention on medication adherence using the Modified Medication Adherence Rating Scale.
Timepoint [3] 421396 0
6 weeks, 3 months, 6 months and 12 months post-intervention commencement
Secondary outcome [4] 421397 0
To assess changes in AF-related knowledge using Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ).
Timepoint [4] 421397 0
6 weeks, 3 months, 6 months and 12 months post-intervention commencement
Secondary outcome [5] 421695 0
To assess changes in AF-related quality of life using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire.
Timepoint [5] 421695 0
6 weeks, 3 months, 6 months and 12 months post-intervention commencement
Secondary outcome [6] 421696 0
To evaluate the cost-effectiveness of the QStream™ intervention by calculating the net cost which is the difference in costs of implementation (testing of QStream intervention) and cost prevented (cost of re-hospitalisation including emergency department visits) derived from hospital medical records. A cost-effectiveness ratio will then be calculated using the net costs and change in health outcomes (number of re-hospitalisations prevented).
Timepoint [6] 421696 0
12 months post-intervention commencement

Eligibility
Key inclusion criteria
Patients visiting the emergency department or admitted to the hospital meeting the following criteria:
• Diagnosis of atrial fibrillation, detected on electrocardiogram (<12 months) or at index presentation or admission
• Age >= 18 years
• Living within the catchment area of the participating hospitals
• English literacy and able to provide informed consent
• Smartphone ownership, able to use smartphone/ digital literacy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age < 18 years
• Living outside the catchment area of the participating hospitals
• Absence of electrocardiographic documentation of atrial fibrillation during index admission or admission
• End-stage heart failure (NYHA Class IV, LVEF <20%)
• Cardiac surgery < 2 months prior to index presentation or admission
• Terminal malignancy
• End stage renal dysfunction (history of dialysis or > stage 3 chronic kidney disease)
• Documented thyrotoxicosis or acute pneumonia at index presentation or admission
• Poor English literacy
• Non-independent living
• Inability to provide informed consent
• Inability to independently use a smartphone device

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)
Allocation is concealed via a central randomisation system secured by use of password, and data encryption procedures at the Centre for Chronic & Complex Care Research office. Randomisation will occur once the patient provides consent. The study nurse responsible for recruitment will phone the research office to obtain and inform the patient of their treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants will be performed through the Research Administrative Coordinator at the Centre for Chronic & Complex Care using a block randomisation and computer-generated numbers. The study investigators will not have access to the randomisation schedule. Permutated blocks of various lengths will be used to ensure allocation concealment. A secure remote web based computer generated random numbers will be used, stratified according to gender (0 = female, 1 = male).
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
We will perform descriptive statistics, univariate analysis, and correlations to document the distribution, central tendency, and dispersion as well as the associations between outcomes on study questionnaires and clinical variables. Multivariate analysis will be undertaken to determine the contribution of clinical and non-clinical factors to clinical outcomes where appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
12/09/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
68
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24656 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 24657 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 40266 0
2148 - Blacktown
Recruitment postcode(s) [2] 40267 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 313725 0
Charities/Societies/Foundations
Name [1] 313725 0
Stroke Foundation (Australia)
Country [1] 313725 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Western Sydney Local Health District,
Research & Education Network,
Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 315539 0
None
Name [1] 315539 0
Address [1] 315539 0
Country [1] 315539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312896 0
Western Sydney Local Health District
Ethics committee address [1] 312896 0
HUMAN RESEARCH ETHICS COMMITTEE
Research office, Level 2, REN Building
Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 312896 0
Australia
Date submitted for ethics approval [1] 312896 0
16/02/2023
Approval date [1] 312896 0
03/05/2023
Ethics approval number [1] 312896 0
2023/ETH00310

Summary
Brief summary
INFORM-AF II is a pilot prospective, randomised, open-label, blinded endpoint (PROBE), multicentre trial of a digital atrial fibrillation (AF) education program delivered via QStream™ versus the Stroke Foundation ‘Living with AF’ booklet. The aim of the study is to evaluate the effectiveness of the digital AF education program delivered via QStream™ on re-hospitalisation rates within 12-months of the primary indexed AF diagnosis, all-cause mortality, cardiovascular-related hospitalisation, medication adherence, AF-related knowledge, and quality of life as well determine the cost-effectiveness of the intervention.

The mHealth application is a smartphone-based spaced learning intervention and consists of six case scenario-based AF questions, based on a spaced timing algorithm, delivered over a 6-week period. The mHealth-based intervention is delivered by the QStream digital platform and was co-designed in consultation with stakeholders including patients living with AF, healthcare providers of AF patients and key opinion leaders from the Stroke Foundation, Heart Foundation, non-government organisations and cardiovascular peak bodies.

This trial is informed by our foundational qualitative research which explored the educational and self-management needs of adults living with AF and a recently completed single group feasibility and acceptability study (INFORM-AF) which demonstrated significant improvements in AF knowledge and quality of life at 12 months (yet to be published).

Data collection will be completed through an electronic survey delivered by the study nurse over the phone at 6 weeks, 3 months, 6 months, and 12 months post intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126258 0
A/Prof Caleb Ferguson
Address 126258 0
Associate Professor Chronic & Complex Care
NHMRC Emerging Leadership Fellow

Centre for Chronic and Complex Care Research
Western Sydney Local Health District
Blacktown Hospital
Marcel Street, Blacktown NSW 2148
Country 126258 0
Australia
Phone 126258 0
+61 0410207543
Fax 126258 0
Email 126258 0
[email protected]
Contact person for public queries
Name 126259 0
Caleb Ferguson
Address 126259 0
Associate Professor Chronic & Complex Care
NHMRC Emerging Leadership Fellow

Centre for Chronic and Complex Care Research
Western Sydney Local Health District
Blacktown Hospital
Marcel Street, Blacktown NSW 2148
Country 126259 0
Australia
Phone 126259 0
+61 0410207543
Fax 126259 0
Email 126259 0
[email protected]
Contact person for scientific queries
Name 126260 0
Caleb Ferguson
Address 126260 0
Associate Professor Chronic & Complex Care
NHMRC Emerging Leadership Fellow

Centre for Chronic and Complex Care Research
Western Sydney Local Health District
Blacktown Hospital
Marcel Street, Blacktown NSW 2148
Country 126260 0
Australia
Phone 126260 0
+61 0410207543
Fax 126260 0
Email 126260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
primary and secondary outcome data
When will data be available (start and end dates)?
Will be available at completion of study, with no end date determined
Available to whom?
At discretion of Principal Investigator
Available for what types of analyses?
At discretion of Principal Investigator
How or where can data be obtained?
Access subject to approval by Principal Investigator (email: [email protected]) followed by request and approval sought from ethics review committee.


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.