Protocol Lab for Online Trial Delphi and Question Effects

NCT ID: NCT03498677

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2019-10-30

Brief Summary

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This study nested as a randomized controlled trial within an online Delphi and will assess the impact of using different question section groupings to provide aggregate feedback to participants in an online Delphi study.

Detailed Description

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A similar assessment has been done during the development of a core outcome for critical care trials set with a nested study examining the impact of question order on prioritization of outcomes. Research reports different stakeholders groups may differ in how they value or prioritize research questions and outcomes and it is recommended that each group should be adequately represented.

The Protocol Lab for Online Trials-Delphi (PLOT-D) study will use an online 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.

Conditions

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Behavior, Adaptive Decision Analysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Method of presentation one

Group Type ACTIVE_COMPARATOR

presentation order

Intervention Type BEHAVIORAL

section presentation one

Method of presentation two

Group Type ACTIVE_COMPARATOR

alternative presentation order

Intervention Type BEHAVIORAL

section presentation two

Interventions

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presentation order

section presentation one

Intervention Type BEHAVIORAL

alternative presentation order

section presentation two

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Protocol lab for online trials Delphi (PLOT-D) participants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ThinkWell

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Price, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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ThinkWell

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 29370827 (View on PubMed)

Potter S, Brookes ST, Holcombe C, Ward JA, Blazeby JM. Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery. Trials. 2016 Sep 23;17(1):463. doi: 10.1186/s13063-016-1591-y.

Reference Type BACKGROUND
PMID: 27664072 (View on PubMed)

Snow R, Crocker JC, Crowe S. Missed opportunities for impact in patient and carer involvement: a mixed methods case study of research priority setting. Res Involv Engagem. 2015 Aug 4;1:7. doi: 10.1186/s40900-015-0007-6. eCollection 2015.

Reference Type BACKGROUND
PMID: 29062496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21283604 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29942546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29062516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29076631 (View on PubMed)

Altman DG. Practical statistics for medical research. London: Chapman and Hall; 1991

Reference Type BACKGROUND

Other Identifiers

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PLOT-D Question Effects

Identifier Type: -

Identifier Source: org_study_id

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