Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT03505450
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2018-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Population Compared to Purposive Sampling for Consensus in an Online Delphi Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003258', 'term': 'Consumer Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2018-04-01', 'studyFirstSubmitQcDate': '2018-04-20', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delphi response rate differences as measured by % of completed questions between samples', 'timeFrame': 'Up to 20 weeks or study completion', 'description': 'Full Delphi sample compared to a 10% randomized stratified sample taken from of the 5 stakeholder groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['decision support tools,'], 'conditions': ['Behavior, Consumer']}, 'referencesModule': {'references': [{'pmid': '29370827', 'type': 'BACKGROUND', 'citation': 'Brookes ST, Chalmers KA, Avery KNL, Coulman K, Blazeby JM; ROMIO study group. Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial. Trials. 2018 Jan 25;19(1):66. doi: 10.1186/s13063-017-2405-6.'}, {'pmid': '21283604', 'type': 'BACKGROUND', 'citation': 'Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan 25;8(1):e1000393. doi: 10.1371/journal.pmed.1000393.'}, {'type': 'BACKGROUND', 'citation': 'Fletcher AJ, Marchildon GP. Using the Delphi Method for Qualitative, Participatory Action Research in Health Leadership. International Journal of Qualitative Methods 2014;13:1-18'}, {'pmid': '29942546', 'type': 'BACKGROUND', 'citation': 'Brice A, Price A, Burls A. Creating a database of internet-based clinical trials to support a public-led research programme: A descriptive analysis. Digit Health. 2015 Nov 20;1:2055207615617854. doi: 10.1177/2055207615617854. eCollection 2015 Jan-Dec.'}, {'pmid': '29062516', 'type': 'BACKGROUND', 'citation': 'Bagley HJ, Short H, Harman NL, Hickey HR, Gamble CL, Woolfall K, Young B, Williamson PR. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress. Res Involv Engagem. 2016 Apr 27;2:15. doi: 10.1186/s40900-016-0029-8. eCollection 2016.'}, {'pmid': '29076631', 'type': 'BACKGROUND', 'citation': 'Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, Burls A. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. J Eval Clin Pract. 2018 Feb;24(1):240-253. doi: 10.1111/jep.12805. Epub 2017 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'This study will be nested as a randomized controlled trial within an online Delphi and will assess the effects of the population sampling compared to purposive sampling for consensus in an online Delphi.', 'detailedDescription': 'The Delphi method of engaging panels of experts from specific interest areas has been widely utilized in the for the development of research reporting guidelines, core outcome sets, clinical medicine, nursing practice, medical education and healthcare services. An assessment completed by Atkins and colleagues in 2005 report that a small panel of similarly trained experts can develop reliable criteria that inform judgment and support effective decision-making. Despite the wide applicability of the Delphi methodology, it is not known how the number of participants or their similarity as a stakeholder group influences results in an online Delphi.Purposeful sampling will be used with a randomized sample taken from each stakeholder group for analysis and this analysis will be presented alongside the full analysis and the results compared.\n\nThe Protocol Lab for Online Trials-Delphi (PLOT-D), which will use an online 3-round Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults from an online cohort who are invited to come to consensus in an online Delphi', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Protocol lab online trials Delphi (PLOT-D) Participant\n\nExclusion Criteria:\n\n* None if meets inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03505450', 'briefTitle': 'Effects of Population Compared to Purposive Sampling for Consensus in an Online Delphi Study', 'organization': {'class': 'OTHER', 'fullName': 'ThinkWell'}, 'officialTitle': 'Effects of Population Compared to Purposive Sampling for Consensus in an Online Delphi Study', 'orgStudyIdInfo': {'id': 'PLOT-D Sampling Type Effects'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population sample', 'interventionNames': ['Other: Population Sample']}, {'label': 'Purposive Sample', 'interventionNames': ['Other: Purposive sample']}], 'interventions': [{'name': 'Population Sample', 'type': 'OTHER', 'description': 'full sample of recruited participants', 'armGroupLabels': ['Population sample']}, {'name': 'Purposive sample', 'type': 'OTHER', 'description': 'purposive sample of recruited participants', 'armGroupLabels': ['Purposive Sample']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX4 4DN', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'ThinkWell', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Amy Price, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Post-publication for 5 years', 'ipdSharing': 'YES', 'description': 'Aggregated data available by request from the study investigator', 'accessCriteria': 'Contact study investigator by email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ThinkWell', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}