Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000729921
Ethics application status
Approved
Date submitted
25/05/2020
Date registered
13/07/2020
Date last updated
19/03/2021
Date data sharing statement initially provided
13/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
EDUCATE-AF - A clinician-developed, video-based educational intervention to improve health knowledge in people with atrial fibrillation
Scientific title
EDUCATE-AF - The impact of a clinician-developed, video-based educational intervention on health literacy and medication adherence in people with atrial fibrillation
Secondary ID [1] 301311 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 317496 0
Atrial flutter 317497 0
Condition category
Condition code
Cardiovascular 315598 315598 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the intervention arm will view the study description document and complete baseline surveys. Following this, they will be automatically delivered a series of 4 clinician-developed videos. The videos are 2-5 minutes long, and cover 4 topic areas: 1) What is atrial fibrillation? 2) Management of atrial fibrillation 3) Stroke risk and anticoagulation in atrial fibrillation 4) Lifestyle modification for atrial fibrillation

All intervention participants will receive reinforcement education (videos emailed or texted to participants weekly).

Number of videos watched and length of time spent on each video will be measured for intervention participants to ensure intervention adherence.
Intervention code [1] 317611 0
Other interventions
Comparator / control treatment
Patients randomised to the control arm will receive usual care. In the clinic waiting room this involves generic posters and pamphlets and any general education received from clinicians during the appointment. Among inpatients this involves any general education delivered by clinicians during the hospital stay.
Control group
Active

Outcomes
Primary outcome [1] 323837 0
Jessa Atrial Fibrillation Knowledge Questionnaire (JAFKQ) score (max score = 100)
Timepoint [1] 323837 0
90 day follow up
Secondary outcome [1] 383020 0
Morisky 8-item medication adherence scale score, measured as proportion with medium or greater adherence (greater than or equal to 6/8) vs ‘low adherence’ (less than or equal to 5/8).
Timepoint [1] 383020 0
90 day follow up
Secondary outcome [2] 383021 0
Jessa Atrial Fibrillation Knowledge Questionnaire (JAFKQ)
Timepoint [2] 383021 0
Within 2 days of intervention delivery
Secondary outcome [3] 383022 0
Clinical care satisfaction, measured on a 7 point likert scale
Timepoint [3] 383022 0
Within 2 days of intervention delivery
Secondary outcome [4] 383023 0
Motivation to maintain adherence to AF-related therapy on a 7-point Likert scale
Timepoint [4] 383023 0
Within 2 days of intervention delivery

Eligibility
Key inclusion criteria
1. Adults aged 18 years and over
2. Atrial fibrillation or atrial flutter diagnosed on electrocardiogram
3. CHA2DS2VASc > 0 and/or currently prescribed anticoagulation therapy
4. Have an email address or active mobile number
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Too unwell (physically or mentally) to participate in surveys
2. Previously allocated to either condition of the study
3. Insufficient English to understand video content or to participate in the audit surveys

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 concealed - uploaded into back-end of video delivery platform
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur centrally via a computer-generated sequence, using the randomise R library of R statistical software (version 3.5.1), before the study commences. Randomisation will be 1:1 and in randomised permuted blocks of 6 and 4 to reduce predictability and ensure a balance between the two arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis will follow intention to treat principles with all participants analysed in the arm they have been randomised to. P-values of < 0.05 will be considered significant. Primary outcome analysis will use a two-tailed t-test to assess the difference between mean participant JAFKQ scores (max score = 100). Analysis will also be performed utilizing an Analysis of Covariance (ANCOVA), with baseline JAFKQ scores and education level incorporated into the model as covariates. A sample size of 360 participants (180 per arm) would, allowing for 15% attrition and assuming a standard deviation of 18 as described in other studies,7 have 90% power (2 sided, type 1 error of 5%) to detect an difference in 90-day AF knowledge of 6.7% between participants in the intervention and control arms of the study, which we consider a significant improvement in knowledge. Previous assessment of the JAFKQ has indicated participant scores 1 month post-test with no educational intervention are unchanged (60.4 [SD = 18.6] vs 62.3 [SD = 18.5]; p = 0.551).(1)

For secondary analysis of satisfaction with clinical care and medication adherence, patient responses will be dichotomised into ‘satisfied’ (greater than or equal to 5/7) vs ‘unsatisfied’(greater than or equal to 3/7) and ‘medium or greater adherence’ (greater than or equal to 6/8) vs ‘low adherence’ (greater than or equal to 5/8).8 Proportions in intervention vs control arms will be compared using a chi-squared test. Relative risk will be calculated using a log binomial unadjusted and adjusted for total time in clinic (for outpatients) and number of medications. Allowing for 15% attrition and assuming 60% satisfaction/medium or greater adherence in the control groups, a sample size of 360 (180 per arm) would have 80% power to detect a relative risk difference in satisfaction and adherence between control and intervention groups of 1.31 (that is, an increase from 60.0% to 78.6%).

1. Desteghe L, Engelhard L, Raymaekers Z, et al. Knowledge gaps in patients with atrial fibrillation revealed by a new validated knowledge questionnaire. Int J Cardiol. 2016;223:906-914. doi:10.1016/j.ijcard.2016.08.303

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2020
Actual
18/11/2020
Date of last participant enrolment
Anticipated
31/07/2021
Actual
Date of last data collection
Anticipated
29/10/2021
Actual
Sample size
Target
360
Accrual to date
74
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16698 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 30297 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 305749 0
Hospital
Name [1] 305749 0
Research and Education Network, Westmead Hospital
Country [1] 305749 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Westmead Hospital
Corner Darcy and Hawkesbury Roads
Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 306250 0
University
Name [1] 306250 0
University of Sydney
Address [1] 306250 0
City Road
Camperdown, NSW, Australia
2008
Country [1] 306250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306023 0
Western Sydney Local Health District
Ethics committee address [1] 306023 0
Ethics committee country [1] 306023 0
Australia
Date submitted for ethics approval [1] 306023 0
12/05/2020
Approval date [1] 306023 0
18/08/2020
Ethics approval number [1] 306023 0

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

Contacts
Principal investigator
Name 102454 0
Dr Aravinda Thiagalingam
Address 102454 0
Westmead Hospital
Corner Darcy and Hawkesbury Roads, Westmead
NSW 2145
Country 102454 0
Australia
Phone 102454 0
+61288905555
Fax 102454 0
Email 102454 0
aravinda.thiagalingam@sydney.edu.au
Contact person for public queries
Name 102455 0
Daniel Mcintyre
Address 102455 0
Westmead Hospital
Corner Darcy and Hawkesbury Roads, Westmead
NSW 2145
Country 102455 0
Australia
Phone 102455 0
+61288905555
Fax 102455 0
Email 102455 0
daniel.mcintyre@sydney.edu.au
Contact person for scientific queries
Name 102456 0
Daniel Mcintyre
Address 102456 0
Westmead Hospital
Corner Darcy and Hawkesbury Roads, Westmead
NSW 2145
Country 102456 0
Australia
Phone 102456 0
+61288905555
Fax 102456 0
Email 102456 0
daniel.mcintyre@sydney.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?
If requested following publication, we may provide de-identified individual participant data that pertain to the published results only.
When will data be available (start and end dates)?
Data will be available following the publication of trial results and key trial papers, which we anticipate to be by December 2022. There is no end date determined as of yet for IPD availability.
Available to whom?
Data will be made available only to researchers who provide a methodologically sound proposal and after the signing of a non-disclosure agreement
Available for what types of analyses?
Data will be available for any purpose deemed reasonable by investigators following review of a data use proposal.
How or where can data be obtained?
Data will be made available by emailing the principal investigator of this study at aravinda.thiagalingam@sydney.edu.au


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
SourceTitleYear of PublicationDOI
EmbaseClinician-Created Video Education for Patients with AF: A Randomized Clinical Trial.2023https://dx.doi.org/10.1001/jamanetworkopen.2023.45308
N.B. These documents automatically identified may not have been verified by the study sponsor.