Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04185818
Status:
UNKNOWN
Last Update Posted:
2020-01-31
First Post:
2019-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Citizen Science: The People's Trial: A Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-06-23', 'releaseDate': '2022-03-14'}], 'estimatedResultsFirstSubmitDate': '2022-03-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'C564092', 'term': 'Bornholm Eye Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The People's Trial is an online pragmatic, randomised controlled trial."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-30', 'studyFirstSubmitDate': '2019-11-28', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall sleep quality', 'timeFrame': 'From time of randomisation- refers to sleep in the last 7 days only', 'description': 'Sleep quality will be measured using the single item sleep quality scale (SQS) (Snyder et al 2018). The SQS is a self-administered questionnaire in which respondents rate overall quality of sleep over a 7-day recall period on a discretizing visual analogue scale from 0 to 10 (0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent)'}], 'secondaryOutcomes': [{'measure': 'Sleep Disturbance', 'timeFrame': 'From time of randomisation- refers to sleep in the last 7 days only', 'description': 'This will be measured using the PROMIS Short Form Sleep Disturbance Scale which measures eight items on 5-point scale to rate the frequency of problems related to insufficient sleep in the past seven days'}, {'measure': 'Daytime sleepiness', 'timeFrame': 'From time of randomisation- refers to sleep in the last 7 days only', 'description': 'Perceptions of daytime sleepiness will be measured using a a single item with a 10-point scale. Respondents are instructed to indicate their sleepiness at that moment by choosing a number between 1 (not sleepy at all) and 10 (very sleepy). Others have found a single item to measure sleep quality produces reproducible and valid data (Cappelleri, et al 2009, Riegel et al 2013).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep, book, read, bed'], 'conditions': ['Sleep']}, 'referencesModule': {'references': [{'pmid': '35264220', 'type': 'DERIVED', 'citation': "Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. The People's Trial: supporting the public's understanding of randomised trials. Trials. 2022 Mar 9;23(1):205. doi: 10.1186/s13063-021-05984-1."}, {'pmid': '34996514', 'type': 'DERIVED', 'citation': "Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed? The People's Trial-an online, pragmatic, randomised trial. Trials. 2021 Dec 4;22(1):873. doi: 10.1186/s13063-021-05831-3."}]}, 'descriptionModule': {'briefSummary': "The People's trial is an online pragmatic, randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.", 'detailedDescription': "The People's Trial seeks to help enhance the public's understanding of randomised trials by facilitating the involvement of the public in the trial research process. The public have, through an online format, guided the development and design of The People's Trial randomised controlled trial. The People's trial is a parallel, online randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.\n\nMembers of the public will be recruited through online platforms. Informed consent will be obtained from all participants prior to trial registration. Consent forms will be provided online prior to registration for The People's Trial. Participants will be required to acknowledge that they have read the consent form and give consent to proceed with trail registration.\n\nParticipants will be randomly allocated into one of two groups:\n\nGroup 1: Reading a book in bed\n\nGroup 2: Not reading a book in bed"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age on enrollment;\n* English speaking;\n* ability to read;\n\nExclusion criteria\n\n* Members of the public who are unwilling or unable to give informed consent.\n* Unable to go to bed and wake up at the same time as normal for the study duration.\n* Unable to sleep in their own bed, in their own home for the study duration\n* Unable to not eat food or drink caffeinated drinks within 1 hour of bed for the study duration'}, 'identificationModule': {'nctId': 'NCT04185818', 'briefTitle': "Citizen Science: The People's Trial: A Randomised Controlled Trial", 'organization': {'class': 'OTHER', 'fullName': 'National University of Ireland, Galway, Ireland'}, 'officialTitle': "Citizen Science: The People's Trial: A Randomised Controlled Trial", 'orgStudyIdInfo': {'id': "HRB.ThePeople'sTrial"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reading group', 'description': 'Participants will:\n\n1. Read a book for 15 to 30 mins\n2. Read immediately before trying to go to sleep.', 'interventionNames': ['Other: Reading a book']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will:\n\n1\\. Not read a book'}], 'interventions': [{'name': 'Reading a book', 'type': 'OTHER', 'description': "Participants requested to specify usual genre of book they read.\n\n1. Fiction\n2. Non-Fiction\n3. Other\n4. Don't usually read a book in bed", 'armGroupLabels': ['Reading group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H91 TK33', 'city': 'Galway', 'state': 'Co. Galway', 'country': 'Ireland', 'facility': 'National University of Ireland Galway', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'Declan Devane, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Ireland, Galway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Ireland, Galway, Ireland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Research Board, Ireland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific Director, HRB-Trials Methodology Research Network', 'investigatorFullName': 'Prof. Declan Devane', 'investigatorAffiliation': 'National University of Ireland, Galway, Ireland'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-03-14', 'type': 'RELEASE'}, {'date': '2022-06-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Prof. Declan Devane, Scientific Director, HRB-Trials Methodology Research Network, National University of Ireland, Galway, Ireland'}}}}