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Trial registered on ANZCTR
Registration number
ACTRN12624001125516
Ethics application status
Approved
Date submitted
3/09/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
e-HANDI for prescribing Non-Drug Interventions in Primary Care: a pilot randomised controlled trial
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Scientific title
Feasibility and Acceptability of the co-designed e-HANDI for Prescribing Non-Drug Interventions (NDIs) in General Practice: A pilot randomised controlled trial
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Secondary ID [1]
312881
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cardiovascular
335034
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chronic condition
335035
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Condition category
Condition code
Cardiovascular
331539
331539
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0
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Hypertension
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Diet and Nutrition
331540
331540
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0
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Other diet and nutrition disorders
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Musculoskeletal
331541
331541
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
e-HANDI is a web-based tool designed to assist primary care physicians (GPs) in prescribing non-drug interventions (NDIs). It's developed in collaboration with GPs and patients to ensure practicality and ease of use. e-HANDI is a standalone web-based tool that GPs will use during the consultation should they want to search for and/or prescribe evidence-based, effective, non-drug interventions. Patients can receive their prescriptions either paper-based or electronic (message or email). The prescription and patient's use can be anonymously tracked and used to generate the feedback report.
Key functions include the e-prescription of effective NDIs such as the Mediterranean diet and cognitive behavioural therapy for insomnia and depression; feedback to GPs by generating reports for GPs comparing their NDI prescription patterns to peers and provide them with actionable plans to improve their prescription behaviours; and reminder systems to patients to encourage adherence to prescribed NDIs (i.e., fortnightly text messages for patients have not opened their prescription for 2 weeks).
The intervention will be provided for the whole duration of the study (24 weeks).
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Intervention code [1]
329420
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Treatment: Other
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Intervention code [2]
329421
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Lifestyle
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Intervention code [3]
329422
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Behaviour
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Comparator / control treatment
standard practice. GPs will receive a monthly newsletter featuring newly added NDIs to RACGP HANDI. GPs can still advice and prescribe NDIs to their patients but will not have access to e-HANDI.
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Control group
Active
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Outcomes
Primary outcome [1]
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Prescription rates of non-drug interventions
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Assessment method [1]
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We will use two methods for measuring the prescription rates:
Self-reported survey: We will survey participants about their non-drug intervention prescription (overall and treatment-specific) using a questionnaire modified from a previously used (Albarqouni 2023 BMJ Family Medicine and Community Health).
2- e-HANDI: using the tracking function that records the prescription of NDIs.
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Timepoint [1]
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at weeks 2, 6, 12, and 24 post-intervention commencement
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Secondary outcome [1]
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The Acceptability of the Intervention
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Assessment method [1]
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We will use the validated Acceptability of Intervention Measure (AIM) to measure the acceptability of the intervention. This is a validated measure that uses Likert scale response values for each item ranging from 1 to 5, with 1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree and 5=strongly agree. A score of >3 is considered an affirmative response for acceptability.
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1): 108.
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Timepoint [1]
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at week 24 post-intervention commencement.
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Secondary outcome [2]
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Feasibility of Intervention Measure (FIM)
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Assessment method [2]
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We will use the validated measure, Feasibility of Intervention Measure (FIM), that uses Likert scale response values for each item ranging from 1 to 5, with 1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree and 5=strongly agree. A score of >3 is considered an affirmative response feasibility.
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1): 108.
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Timepoint [2]
439571
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at week 24 post-intervention commencement.
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Secondary outcome [3]
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Appropriateness of Intervention Measure (IAM)
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Assessment method [3]
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We will use a validated measure that use Likert scale response values for each item ranging from 1 to 5, with 1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree and 5=strongly agree. A score of >3 is considered an affirmative response appropriateness..
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Timepoint [3]
439572
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at week 24 post-intervention commencement.
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Secondary outcome [4]
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Dispensing rates of non-drug interventions
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Assessment method [4]
439573
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We will measure that using e-HANDI, using the tracking function that records the patient use of NDIs.
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Timepoint [4]
439573
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at week 24 post-intervention commencement.
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Secondary outcome [5]
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Scalability of the intervention
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Assessment method [5]
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We will undertake in-depth, semi-structured interviews with a subset of participants (a convenient sample of the first 20 patients to accept GP invitations) to explore the acceptability and feasibility of interventions from the perspectives of both GPs and patients. This will encompass exploring various aspects such as the use of e-HANDI, feedback summaries, interactions with patients, and the use of HANDI consumer resources. The interviews will be conducted via telephone or videoconference (e.g., Zoom) or face-to-face.
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Timepoint [5]
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at week 24 post-intervention commencement
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Eligibility
Key inclusion criteria
We will recruit general practitioners (GPs) through our established networks of GPs including advertising by Australian Practice-Based Research Networks (e.g., GoldNet practice-based primary care research network in Southeast Queensland), and direct approach to GPs that are currently involved in various research programs within the Institute for Evidence Based Healthcare (IEBH). To be eligible, GPs should have been actively engaged in clinical practice within the past 12 months. Eligible participants may come from a range of experience levels and diverse geographical locations across Australia.
Patients will be recruited through GPs and e-HANDI. To be eligible, they should be adult (>18 years old) with a chronic condition and prescribed one of the effective NDIs in RACGP HANDI.
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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?
Yes
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Key exclusion criteria
International GPs
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of GPs (1:1 for intervention:control) will be conducted by an independent researcher (not involved with intervention delivery or outcome measurement) using a computer-generated randomisation program and will be stratified according to remoteness (urban/regional areas) and workload. Study personnel involved in analysing study data will be blinded to the group allocation. Following randomisation and allocation, GPs, practice staff, and researchers involved in the intervention delivery will not be blinded to the group allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of GPs (1:1 for intervention:control) will be conducted by an independent researcher (not involved with intervention delivery or outcome measurement) using a computer-generated randomisation program and will be stratified according to remoteness (urban/regional areas) and workload. Study personnel involved in analysing study data will be blinded to the group allocation. Following randomisation and allocation, GPs, practice staff, and researchers involved in the intervention delivery will not be blinded to the group allocation.
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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
Parallel
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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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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NHMRC
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
317322
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Charities/Societies/Foundations
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Name [2]
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Heart Foundation
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Address [2]
317322
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Country [2]
317322
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Australia
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Primary sponsor type
Government body
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Name
NHMRC
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Address
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Country
Australia
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Secondary sponsor category [1]
319604
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Charities/Societies/Foundations
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Name [1]
319604
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Heart Foundation
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Address [1]
319604
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Country [1]
319604
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316052
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Bond University Human Research Ethics Committee
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Ethics committee address [1]
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https://bond.edu.au/ethics
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Ethics committee country [1]
316052
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Australia
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Date submitted for ethics approval [1]
316052
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Approval date [1]
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28/03/2024
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Ethics approval number [1]
316052
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CD03291
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Summary
Brief summary
This is a randomised controlled trial to evaluate the acceptability, feasibility, and potential efficacy of a novel web-based electronic point-of-care tool, "e-HANDI," to facilitate GPs' prescription and patients' use of effective NDIs in primary care. e-HANDI is a web-based user-centred point-of-care tool that is systematically developed from the bottom-up to facilitate easier, practical prescribing of NDIs in primary care.
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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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A/Prof Loai Albarqouni
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Address
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Institute for Evidence-Based Healthcare Faculty of Health Sciences and Medicine Bond University 14 University Dr, Robina, QLD, Australia 4229
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Country
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Australia
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Phone
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+61 7 5595 5201
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Fax
136622
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Email
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lalbarqo@bond.edu.au
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Contact person for public queries
Name
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Loai Albarqouni
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Address
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Institute for Evidence-Based Healthcare Faculty of Health Sciences and Medicine Bond University 14 University Dr, Robina, QLD, Australia 4229
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Country
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Australia
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Phone
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+61 7 5595 5201
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Fax
136623
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Email
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lalbarqo@bond.edu.au
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Contact person for scientific queries
Name
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Loai Albarqouni
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Address
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Institute for Evidence-Based Healthcare Faculty of Health Sciences and Medicine Bond University 14 University Dr, Robina, QLD, Australia 4229
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Country
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Australia
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Phone
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+61 7 5595 5201
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Fax
136624
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Email
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lalbarqo@bond.edu.au
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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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