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INFORM-AF II – A pilot randomised controlled trial of a digital atrial fibrillation (AF) education program for people living with AF.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000625673
Acronym
INFORM-AF II
Enrollment
68
Registered
2023-06-07
Start date
2023-09-12
Completion date
2024-12-31
Last updated
2024-09-16

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

Conditions

None listed

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.

Interventions

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 participa

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).

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

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: • 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

• 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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026