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Trial registered on ANZCTR
Registration number
ACTRN12624000618550
Ethics application status
Approved
Date submitted
23/04/2024
Date registered
13/05/2024
Date last updated
18/07/2024
Date data sharing statement initially provided
13/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Can AI deliver empathetic medical consultations?
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Scientific title
How do perceptions of clinical empathy differ when a digital human delivers a brief medical consultation compared to a human physician?
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Secondary ID [1]
311984
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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:
lack of clinical empathy in medical consultations, especially in primary care
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Condition category
Condition code
Public Health
330284
330284
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Specific intervention: Participants watching a medical consultation delivered by a Digital Human (DH). DHs are embodied conversational agents (ECAs) whose interactions are shaped by artificial intelligence (Loveys et al., 2022). DHs possess dialogue systems, allowing them to communicate with users through text and speech-based channels (Loveys, 2021). DHs may take on various forms with animated faces or bodies, ranging from simple, cartoon-like depictions (Hudlicka, 2015) to more complex, realistic, and humanlike embodiments (Loveys, 2021). Participants will be randomly assigned to the intervention condition (medical consultations delivered by a DH), or the control condition (medical consultation delivered by a human physician).
Information for non-drug trials:
Materials used: Through qualtrics (survey platform): Participant information sheet (PIS) and consent forms for participants, videos of brief medical consultations and a questionnaire for participants to complete after watching the video they have been randomly assigned to.
Digital human training/instructional and design materials provided by Soul Machines and IBM Watson for the researchers to create and program the digital human
BMJ Clinical Review article used as an instructional material to devise the script for the medical consultations. The script was used for the consultation delivered by the human physician, which also informs the content for the consultation delivered by the digital human
Filming and electronic equipment used to record videos of the human physician and digital human interacting with an actor patient
Procedures: Firstly, through the qualtrics survey link, participants will be asked to read the PIS, sign a consent form and complete a demographic information questionnaire. Participants will be randomly assigned to one of the four conditions using the qualtrics software, and they will watch a brief video of a medical consultation (empathetic or non-empathetic) delivered by a human physician or a digital human. Next, participants will be asked to fill out a measure of empathy, rating their perceptions of the interaction. Participants will also complete measures of trustworthiness, competence, and warmth, given that these are outcomes closely related to perceptions of physician empathy and can enhance knowledge of the acceptability of digital humans compared to human physicians on multiple fronts. Participants will also be asked about their prior experiences with technology, as those with previous exposure may differ from those without prior knowledge or encounters with digital humans/virtual agents. The administering of these measures will be counterbalanced, given the possibility for the first measure to prime responses to the subsequent measures. However, counterbalancing will depend on the parameters of qualtrics.
Who will deliver the intervention and their expertise: The intervention will be delivered by a Digital Human. Participants will have access to pre-recorded videos embedded into the qualtrics survey, where they will watch the consultation they have been randomly assigned to before answering the survey questions. The digital human delivering the medical consultation will be designed and programmed using Soul Machines and IBM Watson, mirroring the content and behaviours of Dr. Anna (the human physicians) in her consultations for comparibility. The human physician delivering the medical consultation is Dr. Anna Perera, a Medical Registrar at Auckland DHB.
Mode of delivery (individual/or group): Individual, as each participant will be randomly assigned to watch either a digital human consultation or a human physician consultation based on the study protocol.
Number of times the intervention will be delievered and over what period of time: For participants assigned to the intervention conditions (Digital human videos: empathetic or non-empathetic), the intervention will be delivered only once per session. This means participants will watch the one pre-recorded video they have been randomly assigned to, lasting approximately 4.5 minutes, and then compltete the attached survey questions. Overall, it is expected that participation will take about 15-20 minutes, of which the intervention will be 4.5 minutes, delivered once per participant.
The location where the intervention occurs: the intervention is delivered through the University of Auckland (UoA) qualtrics platform. The survey link will allow participants access to one of the pre-recorded videos (filmed on the UoA campus), and the study measures.
Digital human intervention: The content of the digital human intervention will be based on the human physician videos. Dr. Anna Perera (the human physician) was consulted in designing an empathetic and non-empathetic consultation, along with a literature review. The digital human will be scripted to say the same things as Dr. Anna in her videos, to keep the content as similar as possible with minor changes to account for the modality. In sum, the digital human will vary in empathy based on the empathy or non-empathy condition. In each condition, it will ask the student actor (Tim) about his symptoms and suggest that he has a common cold based on his symptoms and provide recommendations such as taking paracetamol and decongestants. In the empathy condition, the digital human will show verbal/non-verbal behaviours indicative of empathy, such as eye contact, smiling, nodding and reflecting the actor's emotions, as well as making empathic statements. In the non-empathetic condition, the digital human will be programmed to not display these behaviours.
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Intervention code [1]
328449
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Treatment: Devices
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Comparator / control treatment
the control group will comprise of the participants watching the pre-recorded videos of the human physician delivering a medical consultation (empathetic or non empathetic), instead of the digital human videos. Similar to the intervention group, the control group will watch one of the human physician videos (pre-recorded), lasting approximately 4.5 minutes, on the qualtrics platform using the survey link. They will then complete the attached measures. Similar to the intervention group, overall participation is expected to last 15-20 minutes, of which the control treatment (the human physcian videos) will be 4.5 minutes.
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Control group
Active
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Outcomes
Primary outcome [1]
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Differences in perceptions of clinical empathy after watching a brief medical consultation
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Assessment method [1]
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We will employ an adapted version of the Consultation and Relational Empathy measure (Mercer et al., 2004) to measure participants' perceptions of empathy in the consultation they have watched. The measure will be modified to suit the DH context by replacing physician/doctor terms with DH for those watching consultations of the DH instead of the human physician. Wording will also be modified to reflect participants' third-person perceptions of the human physicians'/DHs' empathy towards the patient in the video rather than themselves. Patients will respond to 10 statements, rating the physician/DHs empathetic behaviour towards the patient on a scale of 'poor' to 'excellent', with an option to say the behaviour 'does not apply'. This scale has been used to assess patient perceptions of empathy in secondary care and has good internal consistency (Cronbach's alpha equal to .94) and convergent validity (Mercer & Murphy, 2008).
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Timepoint [1]
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once: immediately after watching the video
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Secondary outcome [1]
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Differences in participants' levels of trust towards the human physician or digital human
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Assessment method [1]
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We will adapt and employ Dugan et al.'s (2005) Trust in Physician measure to gauge participants' feelings of trustworthiness towards the physician/DH in the consultation they have watched. Patients will respond to 5 statements on a scale of 'Strongly Disagree' to 'Strongly Agree,' indicating the extent to which the physician or DH's behaviour towards the patient seemed trustworthy. This scale has been used with patient populations in primary care and has good internal consistency (Cronbach's alpha equal to .89), construct validity, and predictive validity (Thom et al., 1999).
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Timepoint [1]
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Once: immediately after watching the video
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Secondary outcome [2]
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differences in the perceptions of the physician's/Digital human's warmth and competence towards the actor patient in the video
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Assessment method [2]
434185
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We will similarly adapt and employ Kraft-Todd et al.'s (2017) Warmth and Competence measure to gauge participants' perceptions of the physician/DH towards the patient in the video. Participants will rate the physician/DH on five characteristics, indicating the extent to which they thought the doctor/DH was competent, confident, independent, competitive, intelligent, tolerant, warm, sincere, and good-natured, each on a 5-point scale with an option of 'does not apply.' This composite measure is based on the means of subscales in independent measures of warmth and competence with good internal consistency (Cronbach's alpha equal to .92 and .71, respectively).
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Timepoint [2]
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once: immediately after watching the video
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Eligibility
Key inclusion criteria
Participants must be over 18 years of age. Participants must have experienced a doctor's visit in the last ten years. Participants must be able to read, speak, and write in fluent
English. Participants must have a stable internet connection and a device such as a phone or a laptop to complete the online survey.
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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
Due to the requirement of watching a brief video, participants with uncorrected visual and hearing impairments that would prevent them from completing the required procedures will be excluded
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Study design
Purpose of the study
Educational / counselling / training
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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)
Yes: the student researcher determining eligibility for participants' inclusion in the trial will not be aware of which condition they will be assigned to. Participants will be randomly assigned to the digital human intervention, or the human physician videos through the qualtrics "randomizer" function. Therefore, the researcher will have no control over which condition participants are assigned to.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the randomizer tool on qualtrics
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/06/2024
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Actual
4/06/2024
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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
136
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Accrual to date
132
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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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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
26251
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Auckland
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Elizabeth Broadbent
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Address
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Country
New Zealand
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Secondary sponsor category [1]
318514
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Individual
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Name [1]
318514
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Ruby Verma
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Address [1]
318514
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Country [1]
318514
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315143
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University of Auckland Human Participants Ethics Committee
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Ethics committee address [1]
315143
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https://www.auckland.ac.nz/en/research/about-our-research/human-ethics.html
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Ethics committee country [1]
315143
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New Zealand
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Date submitted for ethics approval [1]
315143
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28/02/2024
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Approval date [1]
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26/04/2024
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Ethics approval number [1]
315143
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Summary
Brief summary
The lack of qualified healthcare professionals in the workforce to meet the needs of Aotearoa's growing and diverse population presents a significant challenge to providing timely, equitable, and culturally appropriate support. Digital humans (DHs) show particular promise in closing this gap, potentially providing responsive, accessible, cost-effective, and scalable support to patients (Loveys et al., 2020). However, for DHs to foster high user engagement, trust and connection as successful healthcare agents, they must engage in effective patient-centred communication in ways similar to human professionals. The identification and integration of features of DHs that facilitate the formation of high-quality, empathetic relationships with their patients is, therefore essential. The current research will assess whether there is an overall difference in perceptions of empathy when a digital human delivers a brief medical consultation compared to a human physician. As a cornerstone of effective, patient-centred consultation, greater physician empathy drives better clinical outcomes and can further impact appraisals of physicians' trustworthiness, competence, and warmth. Therefore, the present study will extend its inquiry to investigating differences in these variables as secondary outcomes. To reflect real-life conditions regarding the significant demands placed on physicians, the human physician will deliver an empathetic and non-empathetic consultation. The DH will mirror these conditions, The content of the DHs consultation will be modelled on the human physician's consultation. We hypothesize that the empathetic human physcian will be rated most highly on all outcomes, followed by the empathetic DH, the non-empathetic human physician, and the non-empathetic DH.
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Trial website
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Trial related presentations / publications
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Public notes
this study will be recruiting globally, as the survey link will be posted on social media pages relevant to the study that may be international
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Contacts
Principal investigator
Name
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Dr Elizabeth Broadbent
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Address
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FMHS BUILDING 507 - Bldg 507, 28 PARK AVE, GRAFTON, AUCKLAND, 1023, New Zealand
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Country
133802
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New Zealand
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Phone
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+64 211227977
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Fax
133802
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Email
133802
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[email protected]
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Contact person for public queries
Name
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Elizabeth Broadbent
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Address
133803
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FMHS BUILDING 507 - Bldg 507, 28 PARK AVE, GRAFTON, AUCKLAND, 1023, New Zealand
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Country
133803
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New Zealand
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Phone
133803
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+64 211227977
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Fax
133803
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Email
133803
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[email protected]
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Contact person for scientific queries
Name
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Elizabeth Broadbent
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Address
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FMHS BUILDING 507 - Bldg 507, 28 PARK AVE, GRAFTON, AUCKLAND, 1023, New Zealand
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Country
133804
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New Zealand
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Phone
133804
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+64 211227977
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Fax
133804
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Email
133804
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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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