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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05067569
Registration number
NCT05067569
Ethics application status
Date submitted
8/09/2021
Date registered
5/10/2021
Titles & IDs
Public title
App-delivered Sleep ThERapy for Older Individuals With Insomnia
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Scientific title
App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)
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Secondary ID [1]
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X21-0265
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Universal Trial Number (UTN)
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Trial acronym
ASTEROID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insomnia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - SleepFix mobile application
BEHAVIORAL - Sleep Health Education
Experimental: Digital brief behavioural therapy for insomnia - Participants randomised to the digital brief behavioural therapy for insomnia (SleepFix app) will be provided an unique access code to download the app. The intervention uses sleep retraining therapy to reduce excess time spent in bed and retrain sleep by matching time in bed (minimum of five and a half hours) to total sleep time. All participants in the intervention arm will also be provided a sleep-tracking wearable device (Fitbit) which will synchronised bed times (going to bed and rising) and are synchronised with the SleepFix app. Participants wil complete a daily sleep diary, rate sleep quality and mood. The intervention is provided for 6 weeks.
Active comparator: Sleep Health Education wait-list control - Participants randomised to the control group will gain access to the first Sleep Health Education module immediately following completion of baseline questionnaires. There are three modules provided bi-weekly with information about sleep health and broad details about managing sleep disturbances. Participants will receive a link to this information as each module is made available.
Upon completion of the study (week 26), the control group will receive free access to the SleepFix mobile application.
BEHAVIORAL: SleepFix mobile application
The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.
BEHAVIORAL: Sleep Health Education
These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in insomnia symptom severity
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Assessment method [1]
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Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.
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Timepoint [1]
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Change score from baseline at 8 weeks
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Secondary outcome [1]
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Change in subjective sleep quality
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Assessment method [1]
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Subjective sleep quality will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with seven component scores derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality.
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Timepoint [1]
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Change score from baseline at 8 weeks
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Secondary outcome [2]
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Change in sleep onset latency
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Assessment method [2]
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Sleep onset latency will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess sleep onset latency over the last 2 weeks.
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Timepoint [2]
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Change score from baseline at 8 weeks
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Secondary outcome [3]
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Change in wake after sleep onset
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Assessment method [3]
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Wake after sleep onset will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess wake after sleep onset over the last 2 weeks.
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Timepoint [3]
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Change score from baseline at 8 weeks
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Secondary outcome [4]
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Change in total sleep time
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Assessment method [4]
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Total sleep time will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess total sleep time over the last 2 weeks.
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Timepoint [4]
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Change score from baseline at 8 weeks
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Secondary outcome [5]
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Change in fatigue
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Assessment method [5]
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The Flinders Fatigue Scale (FFS) is a 7-item self-reported instrument designed to measure the level of subjective daytime fatigue experienced over the previous two weeks. 6-items consist of a 5-point Likert type scale ranging from "not at all" = 0 to "extremely" = 4. Item 5 uses a multiple-item checklist and is scored as a sum. All items are summed with total scores ranging from 0-31 with higher scores reflecting greater fatigue.
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Timepoint [5]
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Change score from baseline at 8 weeks
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Secondary outcome [6]
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Change in daytime sleepiness
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Assessment method [6]
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The Epworth Sleepiness Scale (ESS) is an 8-item self-reported questionnaire that provides a rating of general sleepiness over the last 2 weeks using a 4-point likert scale from "would never dose" = 0 to "high chance of dozing" = 3. All items are summed with total scores ranging from 0-26 where scores \>10 indicating above-average daytime sleepiness.
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Timepoint [6]
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Change score from baseline at 8 weeks
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Secondary outcome [7]
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Change in quality of Life
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Assessment method [7]
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The EuroQol five-dimensional (EQ-5D) is a self-reported questionnaire which assesses 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and overall health. The 5 dimensions range from "1 = indicating no problem" - "5 = indicating unable to/extreme problems" and the overall score from 0 (worst health state imaginable) to 100 (best health state imaginable).
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Timepoint [7]
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Change score from baseline at 8 weeks
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Secondary outcome [8]
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Change in depressive symptoms
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Assessment method [8]
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The Patient Health Questionnaire-9 is a 9-item self-reported measure of depressive symptoms over the past 2 weeks. Scores for each question (Likert type scale "not at all" = 0 to "nearly every day" = 3) sum to a total score out of 27 with higher scores reflecting severe depressive symptoms.
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Timepoint [8]
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Change score from baseline at 8 weeks
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Secondary outcome [9]
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Change in anxiety
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Assessment method [9]
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The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety over the previous 2 weeks. It consists of a three-point Likert type scale for each item (ranging from "not at all" = 0 to "nearly every day" = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively.
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Timepoint [9]
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Change score from baseline at 8 weeks
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Secondary outcome [10]
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Change in self-reported cognition
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Assessment method [10]
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The British Columbia Cognitive Complaints Inventory (BC-CCI) is a 6-item tool to assess self-perceived cognition. It explores any perceived problems associated with cognition, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems in reflection of the last 7 days. Answers for each question range from 0 (= "not at all") to 3 (= "Very much"). Scores are summed to a total out of 18 that reflects the cognitive complaint severity.
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Timepoint [10]
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Change score from baseline at 8 weeks
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Secondary outcome [11]
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Engagement
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Assessment method [11]
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To determine if there is a relationship between therapeutic outcome (Insomnia Severity Index, ISI) and engagement (number of in-app sleep diary entries for study completers)
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Timepoint [11]
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Baseline, week 8
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Secondary outcome [12]
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The effect of baseline digital health literacy on therapy efficacy
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Assessment method [12]
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Digital health literacy will be assessed using the eHEALS Literacy Scale (eHEALS) which is an 8-item, 5-point Likert-type questionnaire that measures a participant's perception of, and ability toward electronic health information. Responses range from "strongly disagree" =1, to "strongly agree" = 5. Total scores are summed to range from 8 to 40 where lower scores indicate lower self-reported digital health literacy.
The moderating effect of the baseline digital health literacy on therapeutic outcomes (ISI scores) and engagement (number of daily sleep diary entries) will be assessed.
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Timepoint [12]
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Baseline, week 8
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Eligibility
Key inclusion criteria
1. Older adults aged = 60 years
2. Able to give informed online consent
3. Insomnia Severity Index = 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
4. English fluency
5. Access to a smartphone and willingness/proficiency to use a mobile app
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Minimum age
60
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
1. Shift-workers
2. Travel to a destination with >2 hours time-difference (within 30-days)
3. Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
4. Diagnosed sleep disorders other than insomnia
5. Regular sleep medications or sleep devices (>2 times a week over last 6 months)
6. Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
7. Drive for work/operate heavy machinery
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2022
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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
6/05/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
270
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Sydney
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Recruitment postcode(s) [1]
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2037 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.
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Trial website
https://clinicaltrials.gov/study/NCT05067569
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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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Ronald Grunstein, MD, PhD
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Address
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Woolcock Institute of Medical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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?
All de-identified data may be made available upon the Principal investigator's agreement with an amendment required to the approving ethics board.
Supporting document/s available: Study protocol, Informed consent form (ICF)
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When will data be available (start and end dates)?
The study data will be available following all analyses.
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Available to whom?
Contact the Coordinating Principal Investigator for access to data.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05067569