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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.
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Scientific title
Efficacy of electronic message-driven patient education program for heart failure best practice care.
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Secondary ID [1]
309754
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None
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Universal Trial Number (UTN)
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Trial acronym
BANDAIDS e-TIPs
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart failure with reduced ejection fraction
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Condition category
Condition code
Cardiovascular
327032
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326199
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Behaviour
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Comparator / control treatment
Single arm study, no control/comparator.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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At 6 months post enrolment.
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Secondary outcome [1]
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Understanding the impact, relevance and timing of the messages as a composite outcome via qualitative survey collection and post-trial interview.
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Assessment method [1]
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Timepoint [1]
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At 6 months post enrolment.
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Secondary outcome [2]
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Exploring the language in the messages - language, tone, intent, message readability via study specific qualitative survey assessment and post-trial interview.
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Assessment method [2]
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Timepoint [2]
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At 6 months post-enrolment.
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Secondary outcome [3]
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What level of customisation is desired to make the e-TIPs program more relevant, via study-specific survey.
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Assessment method [3]
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Timepoint [3]
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At 6 months post enrolment.
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Secondary outcome [4]
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Health related quality of life during study period, via the quality of life measure EQ-5D-5L.
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Assessment method [4]
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Timepoint [4]
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At Baseline and 6 months post enrolment.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2023
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Actual
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Date of last participant enrolment
Anticipated
1/01/2024
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health and Aged Care - Medical Research Future Fund
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Address [1]
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Department of Health and Aged Care
GPO Box 9848
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
NHMRC Clinical Trials Centre
92-94 Parramatta Road,
Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
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Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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27/03/2023
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Approval date [1]
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22/05/2023
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Ethics approval number [1]
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2023/ETH00616
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Summary
Brief summary
Heart failure is a major burden in Australia in terms of morbidity, mortality and healthcare expenditure. While multiple guideline-based therapies are recommended for heart failure with reduced ejection fraction (HFrEF), they are underutilised and thus ineffective. Barriers to guideline adherence for HF management exist at the patient, healthcare provider, and healthcare system level. This study will develop and deploy a heart failure education program, delivered by SMS as "e-TIPs" to patients after a discharge from hospital for heart failure every week for 6 months. We aim to assess the impact and patient-acceptance of the tailored electronic message-driven patient education program in recently admitted HFrEF patients. The study hypothesises that the patient driven education program "e-TIPs" will be acceptable to patients and ehance their self-education and self-management.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Anthony Keech
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Address
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NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 295625000
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Anthony Keech
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Address
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NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 295625000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Anthony Keech
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Address
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NHMRC Clinical Trials Centre
92-94 Parramatta Road
Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 295625000
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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