Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000505808
Ethics application status
Approved
Date submitted
8/03/2021
Date registered
30/04/2021
Date last updated
16/02/2023
Date data sharing statement initially provided
30/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes Clinic: Exercise Physiology group service for older people with type 2 diabetes
Scientific title
Diabetes Clinic: Feasibility and acceptability on an Exercise Physiology group service for older people with type 2 diabetes
Secondary ID [1] 302985 0
None
Universal Trial Number (UTN)
U1111-1262-5251
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 320036 0
Condition category
Condition code
Metabolic and Endocrine 317960 317960 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Diabetes Clinic project aims to examine the feasibility, acceptability and preliminary efficacy of an Accredited Exercise Physiologist (AEP) delivered type 2 diabetes (T2D) group service for older adults. The Diabetes Clinic will be delivered within the UNSW Medicine Lifestyle Clinic, as part of usual clinical service, with the aim of improving diabetes management through increased participation in healthy lifestyle behaviours including exercise. Participants may choose to participate in Part A and/or Part B. Furthermore, those who are not involved in Part A are still eligible to participate in Part B.

The project will have an initial focus group (PART A) conducted 1 month prior to the start of the Diabetes Clinic intervention (PART B). A full qualitative analysis of the information collected in PART A will not be undertaken. Instead, it aims to inform on key logistical aspects of the protocol (e.g. morning vs afternoon sessions, frequency per week, duration of sessions, patient goals, exercise preference, enablers and barriers to attending). Any feedback that is deemed by the research team to warrant a modification of the intended protocol, as is presented in this submission, will be implemented, but only following ethical approval after the modification has been submitted and reviewed. This will be done prior to the commencement of PART B data collection. Part B Focus group will then be conducted at the completion on the group intervention, using quantitative analysis to examine feasibility, acceptability, and impact on health outcomes. Both Part A and Part B Focus groups will go for 45-60 minutes each. The focus groups will be facilitated by two researchers, at least one of whom is an AEP with a minimum of 5 years experience. The focus groups will be conducted online via Microsoft Teams, at a place and time convenient for the participant (e.g. their home). If the participant does not have online access, they may be invited to attend the focus group from an available space within the UNSW Medicine Lifestyle Clinic. If participants do need to attend face-to-face, all necessary social distancing requirements will be adhered to.

PART B: The Diabetes Clinic will be delivered face to face within the UNSW Medicine Lifestyle Clinic (UNSW Sydney Australia) by AEPs with a minimum 5 years experience, as part of usual clinical service, with the aim of improving diabetes management through increased participation in healthy lifestyle behaviours including exercise. The group will have a minimum of 2 and maximum of 12 participants. If there are more than 12 participants enrolled at any one time, a second group will be created to accommodate numbers.

The group services will be delivered as a rolling program, with a group session being delivered once a week to facilitate participant adherence. Following initial assessment (90-120 minutes including health interview, physical assessment and questionnaire completion), each participant will receive 8 sessions at a frequency of once per week. Each session will run between 60-90 minutes to include both and educational (approximately 30 minutes) and exercise (approximately 60 minutes) component.

The educational component will be delivered in Sessions 1-8, ensuring each participant has exposure to all topics irrespective of when they commence the group services. The below topics will be discussed across the 8 sessions with the use of educational material developed by Diabetes Australia, Heart foundation Australia and the Australian Government department of health.

Session 1: Understanding Type 2 Diabetes (fact sheet understanding type2 diabetes)
Session 2: Managing Diabetes as you age (booklet managing diabetes as you age guide for people over 65)
Session 3: Health Care team guide for people over 65 (booklet your health care team guide for people over 65)
Session 4: Physical Activity for diabetes (fact sheet physical activity, physical activity action plan)
Session 5: Diabetes related complications; Strategies for optimal heart health (fact sheet diabetes related complications)
Session 6: Healthy eating guide for people over 65 (booklet healthy eating guide for people over 65, Health weight action plan)
Session 7: Adjusting to life with diabetes (fact sheet adjusting to life with diabetes, Psychological and social health action plan)
Session 8: Physical activity tips and ideas (Choose health brochure, Aus Gov PA tips and ideas older adults)

The exercise component will be evidence based and delivered utilising the variety of exercise equipment available within the UNSW Medicine Lifestyle Clinic. A combination of aerobic, resistance, balance and flexibility exercises will be prescribed as is suitable and relevant to the participant within the group setting. The below exercise prescription guidelines as per American College of Sports Medicine (ACSM) will be followed:

Exercise:
AEROBIC EXERCISE
Frequency 1xwk
Intensity Light-Vigorous (Light: 40-55% HRmax, RPE 8-10; Moderate 55-70%HRmax, RPE 11-13; Vigorous 70-90%HRmax, RPE 14-16)
Time 20-30 minutes
Type Major muscle groups: Cycling (upright/recumbent); Walking (treadmill), rowing, stepping
Volume Aerobic exercise: Frequency x intensity x time
Pattern One continuous bout or multiple bouts (e.g. 30 minutes or 3 x 10 min)
Progression Commence first exercise session in wk 1 at low-moderate intensity (50-60%HRmax, RPE 9-13) and progress gradually as tolerated by the individual


RESISTANCE EXERCISE
Frequency 1xwk
Intensity Light-Vigorous (Light: 30-49%1RM, RPE 9-11; Moderate 50-69%1RM, RPE: 12-13; Vigorous: 70-84%1RM, RPE 14-17)
Time 20-30 minutes
Type Pin-loaded weight plate machined (e.g. Leg Press, Leg Extension, Leg Curl, Seated row, Chest Press, Lat Pulldown) body weight, free weights, therabands.
Sets 1-3
Repetitions 8-12
Volume sets x reps x days
Pattern 2 second concentric, 3 second eccentric. 1-2 minute rest between sets
Progression Commence first exercise session in wk 1 at low-moderate intensity (50-69%1RM, RPE 9-13) and progress gradually as tolerated by the individual

Balance and flexibility exercises will be prescribed and delivered as determined to be suitable to the individuals attending the group. Participants attendance and physical activity enjoyment will be recorded each session. All prescriptive elements of all exercises performed will be recorded on pre-prepared program training sheets by the supervising AEP and supporting 4th year Exercise Physiology undergraduate students each session to ensure all necessary detail is captured.

The final assessment will be completed on the week following the completion of their eighth group session. To account for a real-world setting, the final assessment may be conducted up to 2 weeks after attending their eighth and final group session. The total time commitment for attending the assessments and group sessions is 16 hours over approximately 10 weeks. The 6 month follow up would include another 90-120 minute assessment. PART B Focus groups will be conducted within 1 month of participants completing their final assessment and with a minimum of 2 participants (no maximum).
Intervention code [1] 319270 0
Lifestyle
Intervention code [2] 319271 0
Rehabilitation
Intervention code [3] 319272 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325973 0
Feasibility outcomes will be examined in terms of session attendance frequencies. This will also be reported as a percentage of total attendance. This outcome will be assessed using a session attendance log. Criteria for success will be attendance greater than or equal to 5 out of the 8 group sessions.
Timepoint [1] 325973 0
Assessed at the final assessment (No greater than 2 weeks following the completion of the eighth group session).
Primary outcome [2] 325974 0
Feasibility Feasibility outcomes will be examined in terms of session compliance. This outcome will be assessed using exercise session program sheets.
Timepoint [2] 325974 0
Assessed at the completion of the eighth group session (week 8).
Primary outcome [3] 327087 0
Acceptability Participants’ perspectives on the intervention’s acceptability will be based on feedback captured in the exiting Patient experience questionnaire and in the PART B focus groups. Acceptability will encompass what participants liked most/least about the treatment and their suggestions for the content and format of the sessions.
Timepoint [3] 327087 0
Assessed post intervention (Part B Focus group - no greater than 4 weeks following the completion of the final assessment).
Secondary outcome [1] 389719 0
Body Mass Index (BMI) Weight will be measured using a digital scale with the person fasting, barefoot and dressed only in underwear and a surgical gown. The gown will be weighed and the weight of which will be subtracted from the person's body weight. Height will be measured using a SECA wall mounted stadiometer with the person barefoot and in the hospital gown. BMI will then be calculated using the following formula: weight (kg) divided by height (in metres) squared.
Timepoint [1] 389719 0
BMI will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [2] 389726 0
Waist Circumference. Waist circumference will be measured in cm according to International Diabetes Federation/American Heart Association (IDF/AHA) guidelines, midway between the lowest ribs and the iliac crest.
Timepoint [2] 389726 0
Waist circumference will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [3] 389730 0
Blood Pressure. Resting blood pressure will be assessed via a validated automated sphygmomanometer.
Timepoint [3] 389730 0
Resting blood pressure will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).. It will also be assessed as an outcome at 3 time points: baseline (week -1), midway through the intervention (week 4) and at the end of the intervention (week 8). Resting blood pressure will also be will be measured and recorded prior to each exercise session to ensure participant safety.
Secondary outcome [4] 389734 0
Functional exercise capacity Functional exercise capacity, measured as total meters covered, will be assessed during the 6 minute walk test. The participant will walk as many laps as they can over a predetermined track within 6 minutes, with continuous heart rate and Rate of Perceived Exertion (RPE) monitoring (recorded every minute) by an AEP.
Timepoint [4] 389734 0
Functional exercise capacity will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..
Secondary outcome [5] 389735 0
Muscle strength The difference in muscle strength at initial assessment compared to the final assessment. Lower limb muscular strength will be assessed via a 1 repetition maximum (RM) leg press and/or knee extension and/or leg curl on a pin-loaded machine, with maximum loads lifted added together for lower limb strength. Upper limb strength will be assessed via a 1RM seated row and/or chest press and/or lat pulldown pin-loaded machine, with maximum loads lifted added together for upper body strength. This is a composite primary outcome of whole body strength, which will be calculated by adding the lower body and upper body 1RM strength measures together.
Timepoint [5] 389735 0
Whole body muscle strength will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).. Measurements will also be repeated fortnightly for progression of the intervention, but these measures won’t be used as outcomes.
Secondary outcome [6] 389736 0
Handgrip strength The difference in handgrip strength between groups at the end of the intervention period. This be assessed using a handgrip dynamometer.
Timepoint [6] 389736 0
Handgrip strength will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..
Secondary outcome [7] 389737 0
Cardiovascular Disease risk will be calculated using the ASCVD Risk Estimator Plus (http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) will be used to estimate patient’s 10-year ASCVD risk. The calculator uses the following information: Current Age (years), Sex (male/female), Race (White/African American/Other), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Total Cholesterol (mg/dL), HDL Cholesterol (mg/dL), LDL Cholesterol (mg/dL), History of Diabetes (Yes/No), Smoker (Current/Former/Never), On Hypertension Treatment (Yes/No), On a Statin (Yes/No) and On Aspirin Therapy (Yes/No).
Timepoint [7] 389737 0
ASCVD Risk will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..
Secondary outcome [8] 389738 0
Perceived Physical Activity The Active Australia Survey will be used to assess perceived participation in various types of physical activity as well as establishing awareness of current public health messages about physical activity.
Timepoint [8] 389738 0
Active Australia Survey will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [9] 389739 0
Quality of life Quality of life (as a composite of all 8 sub scales of physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [9] 389739 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [10] 389740 0
Quality of life - Physical functioning Physical functioning (sub scale of physical functioning) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [10] 389740 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [11] 389741 0
Quality of life Role physical (sub scales role physical) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [11] 389741 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [12] 389742 0
Quality of life Bodily pain (sub scale bodily pain) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [12] 389742 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [13] 389743 0
Quality of life General health (sub scales general health) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [13] 389743 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [14] 393739 0
Quality of life Vitality (sub scale vitality) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [14] 393739 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [15] 393740 0
Quality of life Social functioning (sub scales social functioning) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [15] 393740 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [16] 393741 0
Quality of life Role emotional (sub scales role emotional) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [16] 393741 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [17] 393742 0
Quality of life Mental health (sub scale mental health) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [17] 393742 0
SF36 will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [18] 393743 0
Physical Activity Enjoyment The enjoyment of physical activity will be measured using the physical activity enjoyment scale.
Timepoint [18] 393743 0
Physical activity enjoyment will be assessed at 10 time points: Initial Assessment, Sessions 1-8 and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [19] 393744 0
Self-Efficacy Ewart’s Physical Exercise Self-Efficacy Scale will be used to assess self-efficacy.
Timepoint [19] 393744 0
Self-efficacy will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).
Secondary outcome [20] 393745 0
Exercise Mood Mood at initiation, midway and immediately post exercise, will be measured with the Feeling Scale.
Timepoint [20] 393745 0
Mood on immediate completion of exercise testing (6MWT and 1RM tests) will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session). Mood during exercise training sessions 1-8 will be assessed in the last 10 minutes of each exercise session.
Secondary outcome [21] 393746 0
Sleep Quality Sleep quality will be measured using the Pittsburgh Sleep Quality Index (composite measure of sub-scales of 7 components).
Timepoint [21] 393746 0
Sleep quality will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study includes:
• Adults aged 65 or above
• Diagnosed with type 2 diabetes
• Willing to attend the Diabetes Clinic service delivered at the UNSW Medicine Lifestyle Clinic
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study includes:
• Diagnosed with diabetes other than type 2 (e.g. type 1 diabetes, gestational diabetes) as the study is specifically investigating the feasibility of the Diabetes Clinic for people with T2D.
• Display an abnormal cardiovascular (heart rate) response to exercise (as seen during the baseline exercise test) and their doctor does not provide medical clearance to participate in the exercise sessions
• Are unable to speak English and do not have a translator to participate in the service
• Have other health conditions, (e.g. orthopedic or neuromuscular limitations) that prevent them from participating in the exercise sessions
• Are deemed unsuitable for group exercise sessions following initial assessment by an AEP within the UNSW Lifestyle Clinic, preventing you from participating in the exercise sessions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
From data collated in previous research conducted within the UNSW Lifestyle Clinic (Audit of strength clinic training program at the UNSW Medicine Lifestyle Clinic (HC15660)), out of 543 clients attending between July 2014 and March 2020, 67 had T2D (12%, or approximately 11 new clients with T2D attending each year).

For the initial focus group (Part A), the likely minimum number of participants will be 7 and a likely maximum will be 14. We do not anticipate all new clients with T2D to participate in the Part A focus group. However, we do anticipate that some of the new clients, as well as some of the existing ones attending the UNSW Medicine Lifestyle Clinic, with T2D will participate. As focus groups are often only 3-5 people, we expect seven participants to be enough to reach data saturation to inform the design of the intervention.

For the Diabetes Clinic service (Part B), the intended sample size is 40.

With the introduction of a new group service specifically for clients with T2D and associated project advertising in line with approved ethics, we expect there to be an increase in individuals with T2D who may be interested in participating and are suitable for recruitment. In the 12-month period of recruitment for this feasibility project, factoring in average dropout rate of 10% for exercise studies included in recent a meta-analysis [13], we predict n=36+10%(4) = n=40 to be an achievable sample.

There is no data to support a sample size calculation for this feasibility study and the investigators believe n=40 will be sufficient to inform on feasibility and acceptability.

This study is a prospective one-group pre-test/post-test design. Quantitative data will be analysed using SPSS. Data will be checked for normality and reported as mean and standard deviation or median and range as appropriate. Descriptive statistics will be used to analyse frequency and distribution of responses to questionnaire and assessment responses. Qualitative data will be analysed using NVivo (version 12.0) from the focus group PART B responses and will be analysed using reflexive thematic analysis.

Feasibility outcomes will be examined in terms of frequencies and percentages (session attendance and compliance). Participants’ perspectives on the intervention’s acceptability will be based on feedback captured in the exiting Patient experience questionnaire and in the PART B focus groups. Acceptability will encompass what participants liked most/least about the treatment and their suggestions for the content and format of the sessions.

Within group change scores (and 95% confidence intervals) will be calculated for clinical outcomes using available data from initial and final assessments. Statistical significance will be set at p<0.05. No minimum number of training sessions for participant attendance will be required for their data to be eligible for analysis. All participants with complete baseline data will be included using an Intention to Treat analysis. A note of the reasons for non-attendance will be collected and reported.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
28/05/2021
Date of last participant enrolment
Anticipated
12/08/2022
Actual
3/08/2022
Date of last data collection
Anticipated
28/04/2023
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32204 0
2052 - Unsw Sydney
Recruitment postcode(s) [2] 32205 0
2031 - Randwick
Recruitment postcode(s) [3] 32206 0
2032 - Kingsford
Recruitment postcode(s) [4] 32207 0
2032 - Daceyville
Recruitment postcode(s) [5] 32208 0
2031 - Clovelly
Recruitment postcode(s) [6] 32209 0
2031 - Clovelly West
Recruitment postcode(s) [7] 32210 0
2031 - St Pauls
Recruitment postcode(s) [8] 32211 0
2033 - Kensington
Recruitment postcode(s) [9] 32212 0
2034 - Coogee
Recruitment postcode(s) [10] 32213 0
2034 - South Coogee
Recruitment postcode(s) [11] 32214 0
2035 - Maroubra
Recruitment postcode(s) [12] 32215 0
2035 - Maroubra South
Recruitment postcode(s) [13] 32216 0
2035 - Pagewood
Recruitment postcode(s) [14] 32217 0
2036 - Chifley
Recruitment postcode(s) [15] 32218 0
2036 - Eastgardens
Recruitment postcode(s) [16] 32219 0
2036 - Hillsdale
Recruitment postcode(s) [17] 32220 0
2036 - La Perouse
Recruitment postcode(s) [18] 32221 0
2036 - Little Bay
Recruitment postcode(s) [19] 32222 0
2036 - Malabar
Recruitment postcode(s) [20] 32223 0
2036 - Matraville
Recruitment postcode(s) [21] 32224 0
2036 - Phillip Bay
Recruitment postcode(s) [22] 32225 0
2036 - Port Botany
Recruitment postcode(s) [23] 32231 0
2026 - Bondi
Recruitment postcode(s) [24] 32232 0
2026 - Bondi Beach
Recruitment postcode(s) [25] 32233 0
2026 - North Bondi
Recruitment postcode(s) [26] 32234 0
2026 - Tamarama
Recruitment postcode(s) [27] 32235 0
2022 - Bondi Junction
Recruitment postcode(s) [28] 32236 0
2022 - Bondi Junction Plaza
Recruitment postcode(s) [29] 32237 0
2022 - Queens Park
Recruitment postcode(s) [30] 32238 0
2004 - Eastern Suburbs

Funding & Sponsors
Funding source category [1] 307395 0
University
Name [1] 307395 0
UNSW Sydney
Country [1] 307395 0
Australia
Primary sponsor type
Individual
Name
Dr Belinda Parmenter
Address
UNSW Sydney, High Street, Wallace Wurth Building, UNSW Kensignton Campus, NSW Australia 2052
Country
Australia
Secondary sponsor category [1] 308059 0
None
Name [1] 308059 0
None
Address [1] 308059 0
N/A
Country [1] 308059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307482 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 307482 0
Ethics committee country [1] 307482 0
Australia
Date submitted for ethics approval [1] 307482 0
23/11/2020
Approval date [1] 307482 0
05/03/2021
Ethics approval number [1] 307482 0
HC200973

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107386 0
Dr Belinda Parmenter
Address 107386 0
UNSW Sydney Wallace Wurth Building, Sydney, NSW 2052
Country 107386 0
Australia
Phone 107386 0
+61 02 90657411
Fax 107386 0
+61 02 9385 1551
Email 107386 0
[email protected]
Contact person for public queries
Name 107387 0
Kelly McLeod
Address 107387 0
UNSW Sydney Wallace Wurth Building, Sydney, NSW 2052
Country 107387 0
Australia
Phone 107387 0
+61 2 90657480
Fax 107387 0
+61 2 9385 3195
Email 107387 0
[email protected]
Contact person for scientific queries
Name 107388 0
Kelly McLeod
Address 107388 0
UNSW Sydney Wallace Wurth Building, Sydney, NSW 2052
Country 107388 0
Australia
Phone 107388 0
+61 2 90657480
Fax 107388 0
+61 2 9385 3195
Email 107388 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, up until 15 years post publication of research results

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.