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Trial registered on ANZCTR


Registration number
ACTRN12621000421831
Ethics application status
Approved
Date submitted
3/03/2021
Date registered
15/04/2021
Date last updated
19/09/2022
Date data sharing statement initially provided
15/04/2021
Date results information initially provided
19/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The INFORM-AF Pilot Study – A Pilot Feasibility Study of mHealth education program for patients living with Atrial Fibrillation.
Scientific title
The INFORM-AF Pilot Study – A Pilot Feasibility Study of mHealth education program for patients living with Atrial Fibrillation.
Secondary ID [1] 303587 0
nil
Universal Trial Number (UTN)
n/a
Trial acronym
INFORM-AF Pilot
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 320955 0
Condition category
Condition code
Cardiovascular 318768 318768 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a pilot feasibility, quasi-experimental pre-post test design, to evaluate the feasibility and efficacy of a novel digital education program via the QStream platform.

The QStream-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 an earlier research led by Dr 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 is delivered directly to consenting participants’ smart phone. There will be two themes covered by the QStream 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 Pilot module is currently being developed by interdisciplinary experts, clinicians who care for AF patients and patients with AF. This process will include the development of unique case studies. 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.

Participants will be provided a short introduction about the study and will be assisted by the study nurse to download the application to their smartphone device. The study nurse will on-board the patient and provide education on how the QStream learning module works.

Automated delivery of the 6 case scenarios by the QStream platform will follow a standardised spaced algorithm: (a) two questions based on the 2 scenarios 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.

It is estimated that using the app may take approximately 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 your 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.
Once participants have completed the learning module, which is anticipated to take 6 weeks to complete, they will then be provided (conducted by the study nurse via the phone) with a follow-up survey to complete.
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.
The INFORM-AF pilot module is currently being developed. Examples of evidence based materials include references materials from the Heart Foundation, Stroke Foundation and AF Association. Each question is linked to a single case scenario. QStream app analytics will be used to monitor adherence and usage of the intervention.
Intervention code [1] 319876 0
Behaviour
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326715 0
Atrial Fibrillation knowledge measured by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)
Timepoint [1] 326715 0
Baseline, 6 weeks (at end of intervention), and at 3 months, 6 months and 12 months.
Secondary outcome [1] 392456 0
Atrial Fibrillation related quality of life (AF effect on quality of life AFEQT questionnaire)
Timepoint [1] 392456 0
Baseline, 6 weeks (at end of intervention), and at 3 months, 6 months and 12 months.
Secondary outcome [2] 393584 0
System usability (10-item system usability scale, post-survey only)
Timepoint [2] 393584 0
Baseline, 6 weeks (at end of intervention), and at 3 months, 6 months and 12 months.

Eligibility
Key inclusion criteria
Patients visiting the emergency department or admitted to the hospital meeting the following criteria:
• Primary 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
• 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
• Non-independent living

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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
Efficacy
Statistical methods / analysis
Data analysis will be conducted using descriptive statistics. Categorical and continuous data survey data collected via the REDCAP and QStream platforms will be analysed via descriptive methods.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/04/2021
Actual
12/05/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
30/12/2021
Date of last data collection
Anticipated
30/12/2022
Actual
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18842 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 18843 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 33341 0
2148 - Blacktown
Recruitment postcode(s) [2] 33342 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 308008 0
Charities/Societies/Foundations
Name [1] 308008 0
Heart Foundation (Australia)
Country [1] 308008 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] 308732 0
None
Name [1] 308732 0
Address [1] 308732 0
Country [1] 308732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308000 0
Western Sydney Local Health District
Ethics committee address [1] 308000 0
HUMAN RESEARCH ETHICS COMMITTEE
Research office, Level 2, REN Building
Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 308000 0
Australia
Date submitted for ethics approval [1] 308000 0
24/01/2021
Approval date [1] 308000 0
29/03/2021
Ethics approval number [1] 308000 0
2021/ETH00122

Summary
Brief summary
The INFORM-AF Pilot Study is a quasi-experimental pre-post test, pilot-feasibility study of a novel digital education intervention delivered through mobile-based health (mHealth) technology targeted at patients living with atrial fibrillation, in Western and South Sydney. The study will evaluate the feasibility of this education program, in improving the Atrial Fibrillation (AF) patient’s knowledge and quality of life. The study will also assess the usability of the digital education intervention.

The mHealth application is a smartphone-based spaced learning intervention and consists of six case scenario-based Atrial Fibrillation 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 is co-designed in consultation with stakeholders including patients living with AF, healthcare providers of AF patients and key opinion leaders from Stroke Foundation, Heart Foundation, NGOs and cardiovascular peak bodies. This is pilot feasibility study of this educational intervention is informed through our foundational qualitative research that has just concluded and is yet to be published. The study team interviewed a total of 45 participants including clinicians, expert key stakeholder and patients to identify the educational and self-management needs of patients living with AF.

Data collection for this study will be conducted via pre and post implementation electronic surveys, and four follow up phone calls (a technical support check-in during the intervention at 3 weeks, and post-intervention outcome assessment at four time points - 6 weeks, 3 months, 6 months and 12 months).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109182 0
Dr Caleb Ferguson
Address 109182 0
Senior Research Fellow
Heart Foundation Postdoctoral Fellow
NHMRC Emerging Leadership Fellow

Western Sydney Nursing & Midwifery Research Centre
Western Sydney University
Western Sydney Local Health District
Blacktown Clinical and Research School, Blacktown Hospital
Marcel St, Blacktown NSW 2148
Country 109182 0
Australia
Phone 109182 0
+61 0410 207 543
Fax 109182 0
Email 109182 0
c.ferguson@westernsydney.edu.au
Contact person for public queries
Name 109183 0
Dr Caleb Ferguson
Address 109183 0
Senior Research Fellow
Heart Foundation Postdoctoral Fellow
NHMRC Emerging Leadership Fellow

Western Sydney Nursing & Midwifery Research Centre
Western Sydney University
Western Sydney Local Health District
Blacktown Clinical and Research School, Blacktown Hospital
Marcel St, Blacktown NSW 2148
Country 109183 0
Australia
Phone 109183 0
+61 0410 207 543
Fax 109183 0
Email 109183 0
c.ferguson@westernsydney.edu.au
Contact person for scientific queries
Name 109184 0
Dr Caleb Ferguson
Address 109184 0
Senior Research Fellow
Heart Foundation Postdoctoral Fellow
NHMRC Emerging Leadership Fellow

Western Sydney Nursing & Midwifery Research Centre
Western Sydney University
Western Sydney Local Health District
Blacktown Clinical and Research School, Blacktown Hospital
Marcel St, Blacktown NSW 2148
Country 109184 0
Australia
Phone 109184 0
+61 0410 207 543
Fax 109184 0
Email 109184 0
c.ferguson@westernsydney.edu.au

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: c.ferguson@westernsydney.edu.au) 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.