Skip to content

The INFORM-AF Pilot Study – A Pilot Feasibility Study of mHealth education program for patients living with Atrial Fibrillation.

The INFORM-AF Pilot Study – A Pilot Feasibility Study of mHealth education program for patients living with Atrial Fibrillation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000421831
Acronym
INFORM-AF Pilot
Enrollment
32
Registered
2021-04-15
Start date
2021-05-12
Completion date
2021-12-30
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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 anticoagu

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.

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026