NCT03498677

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 29, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

April 1, 2018

Last Update Submit

March 18, 2021

Conditions

Behavior, AdaptiveDecision Analysis

Keywords

online trialdecision analysis

Outcome Measures

Primary Outcomes (1)

  • Context effects of question order

    measure to what extent question section order changes context response between conditions

    Up to 20 weeks or study completion

Secondary Outcomes (2)

  • Question section presentation order

    Up to 20 weeks or study completion

  • Retention

    Up to 20 weeks or study completion

Study Arms (2)

Method of presentation one

ACTIVE COMPARATOR
Behavioral: presentation order

Method of presentation two

ACTIVE COMPARATOR
Behavioral: alternative presentation order

Interventions

presentation orderBEHAVIORAL

section presentation one

Method of presentation one
alternative presentation orderBEHAVIORAL

section presentation two

Method of presentation two

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Protocol lab for online trials Delphi (PLOT-D) participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ThinkWell

Oxford, Oxfordshire, OX4 4DN, United Kingdom

Location

Related Publications (9)

  • 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: 29370827BACKGROUND

  • 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.

    PMID: 27664072BACKGROUND

  • 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.

    PMID: 29062496BACKGROUND

  • 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.

    PMID: 21283604BACKGROUND

  • 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

    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.

    PMID: 29942546BACKGROUND

  • 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: 29062516BACKGROUND

  • 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.

    PMID: 29076631BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

  • Amy Price, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2018

First Posted

April 17, 2018

Study Start

May 29, 2018

Primary Completion

April 30, 2019

Study Completion

October 30, 2019

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Aggregated de-identified data will be available on reasonable request

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Post-study, five years
Access Criteria
Contact study investigator

Locations

GB(1)