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Trial registered on ANZCTR
Registration number
ACTRN12623000434695
Ethics application status
Approved
Date submitted
14/04/2023
Date registered
28/04/2023
Date last updated
4/12/2023
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Bringing Namaste Care to people with dementia at end of life in residential aged care services
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Scientific title
Evaluating the Namaste Care Program on quality of life for people living with advanced dementia in residential aged care services
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Secondary ID [1]
309455
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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:
Dementia
329709
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Quality of life
329787
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Condition category
Condition code
Neurological
326608
326608
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0
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Our project will address the need for a specialised program of care for people with dementia at EOL, by implementing the Namaste Care Program, a structured, non-pharmacological, person-centred group program that provides tailored, multi-sensory activities aimed at improving quality of life. Namaste Care has been specially developed for residents in the advanced stage of dementia, who may become agitated when there is too much stimulation. Namaste Care specifically stimulates a person’s senses to promote comfort and pleasure. Key activities of Namaste Care include options such as gentle face washing and face moisturising, shaving the “old-fashioned way”, hair combing/styling and application of makeup, if desired. Other key activities recommended within the program include hand and foot massage, range of motion exercises, reminiscence activities, interaction with seasonal scents, and other activities tailored to individual recipient preferences when these are known. The program is undertaken in a group setting, and includes family carers, staff and volunteers. The Namaste Care intervention will run for 2 hours, twice per day (am/pm sessions), 7 days a week for the duration of the project (6 months). Namaste Care champions from each service will be responsible for setting up the space and running the daily program. The space is prepared in advance and attention is given to creating a calm, relaxing and welcoming atmosphere. Natural light or low light is provided. Natural aromas are preferred including seasonal scents or an aromatherapy diffuser can be used. Gentle and relaxing sounds or music are used to create an atmosphere rather than providing entertainment. Relaxing visual images e.g. nature images, can be displayed on a screen or the presence of flowers or plants. Residents with advanced dementia are welcomed individually and made comfortable in a recliner chair. A soft blanket is wrapped around them. Pain assessments are undertaken with individual participants at the start of the session and levels of comfort are monitored throughout.
A range of multisensory activities (initiated by staff, family or volunteers) are then provided throughout the session:
• Expressive touch is used to communicate and connect with the residents, such as gentle face washing and hand massage.
• Snacks and beverages are offered to the residents throughout the session so that residents can receive favourite food and drinks, and experience different tastes, textures and sensations.
• Significant engagement items or items tailored for individual residents may be incorporated into the session e.g. personalised music, realistic dolls or animals or robotic simulations
Towards the end of the session, residents are aroused through a change of music, lighting and aromas.
• The Namaste Care Program will be implemented consistent with the implementation protocol for the individual site (developed in Stage 2).
• Data will be collected on resident participants receiving the Namaste Care intervention by Namaste Carers running the program. Two documents will be completed by the Namaste carers, these are: the Namaste Care Record Summary and Namaste Care Session record summary. These documents capture the types of activities that the person enjoys (or not), and the observed behaviours of the person receiving care as well as a progress notes on the Namaste Care session. This data will be collected at T2 (week 2), T3 (week 4) and T4 (week 12).
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Intervention code [1]
325878
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Treatment: Other
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Intervention code [2]
325937
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Lifestyle
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Intervention code [3]
325938
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Participant quality of life assessed using the Quality of Life in Late-Stage Dementia (QUALID) scale.
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Assessment method [1]
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Timepoint [1]
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Baseline, 2, 4 (primary timepoint) and 12 weeks post intervention.
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Primary outcome [2]
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Participant agitated behaviours assessed using the Cohen-Mansfield Agitation Inventory (CMAI).
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Assessment method [2]
334466
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Timepoint [2]
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Baseline, 2, 4 (primary timepoint) and 12 weeks post intervention
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Secondary outcome [1]
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types of activities that the person enjoys (or not) - data collected using a Namaste Care Record Summary and Namaste Care Session record summary
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Assessment method [1]
420793
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Timepoint [1]
420793
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week 2, 4 and 12 post intervention.
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Secondary outcome [2]
420794
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observed behaviours of the person receiving the Namaste Care Program using the Namaste Care Record Summary and Namaste Care Session record summary
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Assessment method [2]
420794
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Timepoint [2]
420794
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week 2, 4 and 12 post intervention
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Eligibility
Key inclusion criteria
Inclusion criteria for residents
# Inability to actively participate in dementia activity/memory programs as assessed by a senior clinical nurse at the service
# FAST 6 or 7 or GDS 6 or 7 or PAS Cognitive Impairment Scale 16-21 – senior clinical nurse will confirm the resident’s score and eligibility from the resident documentation
# Difficulty verbally communicating
# Need for assistance with personal care
# Non-ambulatory
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Minimum age
50
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
Residents who are still able to participate in usual memory support activities;
residents who are likely to be disruptive and/or will wander away, or
who are too unwell to attend the Namaste Care Program intervention.
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Study design
Purpose of the study
Treatment
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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)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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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
Participants can join the program as consent is obtained.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We are aiming for 30 participants over a 6-month timeframe across three services.
Paired t-tests (one-tailed test) will be used to measure differences from baseline to week 4 timepoint.. Magnitude of effect desired is an increase on QUALID between 4 and 10 points to achieve a SD of 6, similar to a previous study with similar sample size.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
25/09/2023
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Actual
12/09/2023
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Date of last participant enrolment
Anticipated
8/12/2023
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Actual
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Date of last data collection
Anticipated
27/02/2024
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Actual
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Sample size
Target
30
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Accrual to date
9
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment postcode(s) [1]
40112
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7004 - Battery Point
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Recruitment postcode(s) [2]
40113
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7249 - Youngtown
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Recruitment postcode(s) [3]
40114
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7015 - Lindisfarne
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Funding & Sponsors
Funding source category [1]
313651
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Commercial sector/Industry
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Name [1]
313651
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Aged Care Research & Industry Innovation Australia (ARIIA)
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Address [1]
313651
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ARIIA: Aged Care Research & Industry Innovation Australia
Level 2, Tonsley Hub, 1284 South Rd, Clovelly Park SA 5042
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Country [1]
313651
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Australia
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Primary sponsor type
University
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Name
University of Tasmania
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Address
Churchill Avenue
Sandy Bay Tasmania 7005 Australia
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Country
Australia
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Secondary sponsor category [1]
315443
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None
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Name [1]
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None
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Address [1]
315443
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None
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Country [1]
315443
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Other collaborator category [1]
282629
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Commercial sector/Industry
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Name [1]
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Southern Cross Care (Tas) Inc.
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Address [1]
282629
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85 Creek Road
New Town Tasmania 7009 Australia
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Country [1]
282629
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312819
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University of Tasmania HREC
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Ethics committee address [1]
312819
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Executive Officer
Research Ethics Unit | Research Division
University of Tasmania
Private Bay 1
Hobart TAS 7001
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Ethics committee country [1]
312819
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Australia
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Date submitted for ethics approval [1]
312819
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21/03/2023
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Approval date [1]
312819
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20/06/2023
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Ethics approval number [1]
312819
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Summary
Brief summary
This project will implement a model of care using the Namaste Care Program for people
living with advanced dementia in Residential Aged Care Services (RACS).
Namaste Care is a non-pharmacological, psychosocial intervention focused on enhancing quality of life in the end stages of dementia and can be provided until the end of life. The program provides structured, personalised, multi-sensory care in a dedicated, peaceful and comfort-orientated space. Namaste care is provided by RACS staff in partnership with family caregivers and volunteers. The project will establish the Namaste Care program in 3 RACS in Tasmania supported by a Namaste Care Community of Care. The project will be the first Australian study to evaluate Namaste Care on eligible residents’ quality of life, aged care workforce satisfaction with care provision and experiences of delivering the program and family carers experiences of care. Evaluation of the project will assess for effectiveness of the intervention and implementation effectiveness. The project aims to show the Namaste Care program intervention is a feasible and acceptable intervention for residents living with advanced dementia, aged care staff and volunteers in RACS, and family carers.
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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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Dr Sara Karacsony
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Address
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School of Nursing, College of Health and Medicine
University of Tasmania
Cnr Church and Glover Street
Lilyfield NSW 2040
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Country
126030
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Australia
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Phone
126030
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+61 2 8572 7993
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Fax
126030
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Email
126030
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[email protected]
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Contact person for public queries
Name
126031
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Dr Sara Karacsony
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Address
126031
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School of Nursing, College of Health and Medicine University of Tasmania Cnr Church and Glover Street Lilyfield NSW 2040
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Country
126031
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Australia
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Phone
126031
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+61 2 8572 7993
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Fax
126031
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Email
126031
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[email protected]
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Contact person for scientific queries
Name
126032
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Dr Sara Karacsony
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Address
126032
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School of Nursing, College of Health and Medicine, University of Tasmania Cnr Church and Glover Street Lilyfield NSW 2040
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Country
126032
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Australia
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Phone
126032
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+61 2 8572 7993
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Fax
126032
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Email
126032
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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)?
Yes
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What data in particular will be shared?
De-identified group data
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When will data be available (start and end dates)?
Immediately following publication - no end date determined
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Available to whom?
Researchers who provided a sound reason for request
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Available for what types of analyses?
Meta -analysis
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How or where can data be obtained?
contact principal researcher by email
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18873
Study protocol
[email protected]
18874
Ethical approval
[email protected]
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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