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Trial registered on ANZCTR
Registration number
ACTRN12624000334505
Ethics application status
Approved
Date submitted
9/02/2024
Date registered
26/03/2024
Date last updated
26/03/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Testing the effectiveness of the Flinders Program in supporting self-management when applied to a group education program for adults with chronic conditions.
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Scientific title
Applying the Flinders Program to support self-management in people with chronic conditions in a group setting: a feasibility study.
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Secondary ID [1]
311346
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None.
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Universal Trial Number (UTN)
U1111-1304-0838
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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:
Chronic Conditions (any)
332622
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arthritis
333008
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diabetes
333009
0
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lung disorders and disease
333010
0
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renal / kidney disease
333011
0
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chronic pain
333012
0
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chronic fatigue
333013
0
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asthma
333014
0
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cancer
333015
0
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cardiovascular / heart disease
333016
0
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Condition category
Condition code
Public Health
329326
329326
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Take Control - Live Well is a group education program consisting of 3 weekly 2-2.5 hour sessions and 1 session after 3 months of completing session 3. The program is run either face-to-face or online (i.e. no hybrid programs). Facilitators provide information on self-management principles (as per the Flinders Program for self-management of chronic conditions) and how these can incorporated into the participants' healthcare and lives. Group discussion is highly encouraged in the groups to support peer-to-peer learning. At the end of the first 2 sessions, activities are worked through which include setting up a plan for behaviour change over the following week which are then reflected on in the subsequent week's session. After the third session, participants write their own Flinders Program Care Plan which outlines a plan to reach their 6-9 month SMART goal (also set in the third session). Participant attendance will be recorded using Canberra Health Service's Digital Health Record as per usual care. Attendance and 'drop-out' rates will be analysed during data analysis.
This is a single centre feasibility/acceptability study using a mixed methods approach (both quantitative and qualitative measures).
As per usual care, trained facilitators will run the “Take Control – Live Well” program either online or face-to-face from March to November 2024. Facilitators are either allied health or nursing professionals working in the Community Care Program at Canberra Health Services who have completed training in the Flinders Program and Take Control - Live Well program delivery. Participants will self-select into the study and, after informed consent is received, be invited to complete anonymous surveys prior to starting the program, after 3-weeks, after the 3-month session and after 6-months. Interviews will be carried out by the principal investigator after the 3-month session.
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Intervention code [1]
327800
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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]
337182
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Self-management competency.
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Assessment method [1]
337182
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Flinders Program Partners In Health Scale.
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Timepoint [1]
337182
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Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
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Primary outcome [2]
337183
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Feasibility
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Assessment method [2]
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Feasibility as a composite measure of recruitment rate, retention rate, study measure completion rate, intervention completion rate, time taken to deliver the program and staff resourcing.
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Timepoint [2]
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End of intervention period.
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Secondary outcome [1]
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Quality of life
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Assessment method [1]
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Work and Social Adjustment Score.
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Timepoint [1]
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Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
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Secondary outcome [2]
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Confidence
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Assessment method [2]
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R-Outcome Health Confidence tool
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Timepoint [2]
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Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
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Secondary outcome [3]
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Program acceptability.
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Assessment method [3]
430996
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Feedback survey which is already used as per usual care.
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Timepoint [3]
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Feeback surveys done at 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
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Secondary outcome [4]
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Program acceptability.
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Assessment method [4]
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Semi-structured qualitative interviews will be conducted with the consenting participants by the research lead. Participants will be given the option to do these via video conferencing if face-to-face is not possible or practical.
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Timepoint [4]
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Interviews will be done with 5 consenting participants after completing their 3-month session.
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Secondary outcome [5]
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Quality of Life
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Assessment method [5]
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R-Outcomes Personal Wellbeing tool.
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Timepoint [5]
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Baseline (completed in session 1 prior to commencement session delivery), 3-weeks (at the end of the third session), 3-months (completed at the end the 3-month session) and 6-months after the third session.
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Eligibility
Key inclusion criteria
- are an adult (18 years of age or older)
- are a resident of the Australian Capital Territory
- have at least one chronic condition (any condition lasting 3 months or more)
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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
Deemed unsuitable for group programs or situations (for example, an uncontrolled mental health condition exhibiting in disruptive behaviours).
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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
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Statistical methods / analysis
Data analysis will be conducted in collaboration with academic staff from Flinders University (Prof. Malcolm Battersby and Dr David Smith). Feasibility data will be analysed and presented descriptively. Descriptive statistics will be used to summarise the screening, eligibility, consent, adverse events, retention, completion and missing data, intervention adherence rates, and sample representativeness and recruitment bias. All pre- and post-intervention analyses will include all available data using linear mixed models to explore differences in PIH, R-Outcomes and WSAS scores before and after program completion, at 3-months and at 6-months. Effect sizes (Cohen’s d) will be calculated for within-group changes.
For interview transcript analysis, theoretical thematic analysis (i.e. explicitly analyst-driven underpinned by self-management theory) at a semantic level (i.e. interpreted in context of existing evidence-base), will be used as outlined by Braun and Clarke (Braun & Clarke, 2006) to identify themes. MS Word will be used in this analysis.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
4/03/2024
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Date of last participant enrolment
Anticipated
31/10/2024
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Actual
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Date of last data collection
Anticipated
31/05/2025
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Actual
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Sample size
Target
52
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
ACT
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Funding & Sponsors
Funding source category [1]
315602
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Hospital
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Name [1]
315602
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Canberra Health Services Allied Health Research Support Grant
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Address [1]
315602
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Country [1]
315602
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Australia
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Primary sponsor type
Hospital
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Name
Canberra Health Services
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Address
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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]
317814
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Address [1]
317814
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Country [1]
317814
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314490
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ACT Health Human Research Ethics Committee
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Ethics committee address [1]
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https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
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Ethics committee country [1]
314490
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Australia
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Date submitted for ethics approval [1]
314490
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22/12/2023
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Approval date [1]
314490
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17/01/2024
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Ethics approval number [1]
314490
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2024.LRE.00007
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Summary
Brief summary
The Take Control - Live Well program is a self-management program for adults living with at least one chronic condition. We have based the program on the Flinders Program which was designed for use in one-on-on consultations. This study is to explore the effectiveness of applying the Flinders Program to a group program setting in providing self-management support for adults living with chronic conditions. We hypothesise that the Flinders Program will be feasible and effective in a group setting.
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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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Ms Chelsea Hillenaar
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Address
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Canberra Health Services, City Community Health Centre, Level 2, 1 Moore Street, Canberra ACT 2601
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Country
131770
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Australia
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Phone
131770
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+61251241581
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Fax
131770
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Email
131770
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[email protected]
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Contact person for public queries
Name
131771
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Chelsea Hillenaar
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Address
131771
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Canberra Health Services, City Community Health Centre, Level 2, 1 Moore Street, Canberra ACT 2601
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Country
131771
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Australia
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Phone
131771
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+61251241581
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Fax
131771
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Email
131771
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[email protected]
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Contact person for scientific queries
Name
131772
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Chelsea Hillenaar
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Address
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Canberra Health Services, City Community Health Centre, Level 2, 1 Moore Street, Canberra ACT 2601
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Country
131772
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Australia
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Phone
131772
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+61251241581
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Fax
131772
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Email
131772
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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
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21604
Informed consent form
387178-(Uploaded-09-02-2024-11-16-50)-Study-related document.docx
21605
Ethical approval
387178-(Uploaded-09-02-2024-11-17-08)-Study-related document.pdf
21606
Study protocol
387178-(Uploaded-09-02-2024-11-17-51)-Study-related document.doc
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.
Download to PDF