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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03505450
Other study ID # PLOT-D Sampling Type Effects
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 29, 2018
Est. completion date October 29, 2018

Study information

Verified date March 2021
Source ThinkWell
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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. The 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.


Recruitment information / eligibility

Status Completed
Enrollment 385
Est. completion date October 29, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Protocol lab online trials Delphi (PLOT-D) Participant Exclusion Criteria: - None if meets inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Population Sample
full sample of recruited participants
Purposive sample
purposive sample of recruited participants

Locations

Country Name City State
United Kingdom ThinkWell Oxford Oxfordshire

Sponsors (1)

Lead Sponsor Collaborator
ThinkWell

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. — View 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. — View 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. — View 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

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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Delphi response rate differences as measured by % of completed questions between samples Full Delphi sample compared to a 10% randomized stratified sample taken from of the 5 stakeholder groups Up to 20 weeks or study completion
See also
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