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Trial registered on ANZCTR


Registration number
ACTRN12623000644662
Ethics application status
Approved
Date submitted
25/05/2023
Date registered
14/06/2023
Date last updated
14/06/2023
Date data sharing statement initially provided
14/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
BANDAIDS – ‘e-TIPS’: Electronic message-driven patient education program for heart failure best practice care.
Scientific title
Efficacy of electronic message-driven patient education program for heart failure best practice care.
Secondary ID [1] 309754 0
None
Universal Trial Number (UTN)
Trial acronym
BANDAIDS e-TIPs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure with reduced ejection fraction 330153 0
Condition category
Condition code
Cardiovascular 327032 327032 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive personalised weekly educational messages (‘e-TIPs’), delivered as a text-message (i.e. Short Message Service, SMS) to the participants’ mobile phones. Each electronic message will contain a ‘short-form’ tip along with a link to the online patient education application which contains more detailed information and links to external references. e-TIPs will be drawn from an e-TIPs bank, and randomly selected from key topic streams such as diet, exercise, medication management and then semi- customised to match the participant’s relevant clinical criteria.

Participants will receive one to four e-TIPs per week, sent at random times between 9 am and 5 pm during weekdays, for 24 weeks (6 months). Messages will be unidirectional, that is, participants will not be encouraged to respond to the messages. Where a return message is received, an automatic reply will be sent informing the participant that the line is unmonitored and to contact their local heart failure nurse for enquires. Aggregated metrics, not linked to participants’ records, will be collected on which tips, topics and external references are clicked.

At the end of the 24 week e-tip program, participants will be invited to conduct a post-trial interview. These will semi-structured interviews based on the Ethics approved topic guide. Interviews will be conducted by expert qualitative BANDAIDS investigators who do not have any access to the participant's clinical records or care. The interviews will last about 30 minutes using a snow-ball sampling approach. Interviews will be recorded for the purposes of transcribing, then records maintained in accordance with relevant privacy laws.
Intervention code [1] 326199 0
Behaviour
Comparator / control treatment
Single arm study, no control/comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334899 0
The useability and usage rates of the e-TIPs program, any barriers to use evalutated via qualtative assessment (assessed as a composite outcome via study-specific surveys).
Timepoint [1] 334899 0
At 6 months post enrolment.
Secondary outcome [1] 422367 0
Understanding the impact, relevance and timing of the messages as a composite outcome via qualitative survey collection and post-trial interview.
Timepoint [1] 422367 0
At 6 months post enrolment.
Secondary outcome [2] 422368 0
Exploring the language in the messages - language, tone, intent, message readability via study specific qualitative survey assessment and post-trial interview.
Timepoint [2] 422368 0
At 6 months post-enrolment.
Secondary outcome [3] 422369 0
What level of customisation is desired to make the e-TIPs program more relevant, via study-specific survey.
Timepoint [3] 422369 0
At 6 months post enrolment.
Secondary outcome [4] 422370 0
Health related quality of life during study period, via the quality of life measure EQ-5D-5L.
Timepoint [4] 422370 0
At Baseline and 6 months post enrolment.

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Admitted to a participating centre, with a diagnosis of HFrEF:
a. confirmed by evidence of left ventricular ejection fraction (LVEF) less than or equal to 40%, or
b. described as at least “moderately” impaired.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inpatients being managed with palliative intent, or who did not survive admission
2. Does not own/have access to a mobile phone to receive SMS (Short Message Service) messages.
3. Unable to understand sufficient written English to provide consent.
4. Unable to provide signed, written informed consent
5. Unable or unwilling to comply with all study requirements, including intervention, timing and/or nature of required assessments.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
A total of up to 500 patients will take part in this study conducted in 6 or more Australian centres.

A process evaluation will be conducted following the Medical Research Council framework to assess feasibility, engagement, and implementation, though the use of intervention usage metrics, structured feedback surveys, and semi-structured interviews with participants. A minimum of 10 interviews will be conducted, however additional interviews will be conducted if needed, until the thematic saturation is reached.

Health-related quality of life will be measured using the generic EuroQOL 5 dimensions, 5 levels (EQ-5D-5L) questionnaire including the Visual Analogue Scale (VAS). EQ-5D-5L scores will be used to derive utility values suitable for the calculation of quality adjusted survival.

A complete Statistical Analysis Plan (SAP) will be developed prior to the final analysis. The analysis plan will be summarised in the published protocol paper.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313944 0
Government body
Name [1] 313944 0
Department of Health and Aged Care - Medical Research Future Fund
Country [1] 313944 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
92-94 Parramatta Road,
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 315810 0
None
Name [1] 315810 0
Address [1] 315810 0
Country [1] 315810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313084 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313084 0
Ethics committee country [1] 313084 0
Australia
Date submitted for ethics approval [1] 313084 0
27/03/2023
Approval date [1] 313084 0
22/05/2023
Ethics approval number [1] 313084 0
2023/ETH00616

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

Contacts
Principal investigator
Name 126942 0
Prof Anthony Keech
Address 126942 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 126942 0
Australia
Phone 126942 0
+61 295625000
Fax 126942 0
Email 126942 0
[email protected]
Contact person for public queries
Name 126943 0
Anthony Keech
Address 126943 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 126943 0
Australia
Phone 126943 0
+61 295625000
Fax 126943 0
Email 126943 0
[email protected]
Contact person for scientific queries
Name 126944 0
Anthony Keech
Address 126944 0
NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
Country 126944 0
Australia
Phone 126944 0
+61 295625000
Fax 126944 0
Email 126944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.