Protocol Lab for Online Trial Delphi and Question Effects

March 18, 2021 updated by: ThinkWell

Effects of Question Section Order on Prioritization of Items by Stakeholder Groups in an Online Delphi Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX4 4DN
        • ThinkWell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None if inclusion criteria are met

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Method of presentation one
Behavioral: presentation order
section presentation one
Active Comparator: Method of presentation two
Behavioral: alternative presentation order
section presentation two

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Context effects of question order
Time Frame: Up to 20 weeks or study completion
measure to what extent question section order changes context response between conditions
Up to 20 weeks or study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Question section presentation order
Time Frame: Up to 20 weeks or study completion
response differences amongst stakeholder groups randomized to 1 of 2 presentation order conditions
Up to 20 weeks or study completion
Retention
Time Frame: Up to 20 weeks or study completion
difference in number of items retained at the end of the first Delphi round by randomized assignment to condition
Up to 20 weeks or study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThinkWell

Investigators

  • Principal Investigator: Amy Price, PhD, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

April 1, 2018

First Submitted That Met QC Criteria

April 14, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLOT-D Question Effects

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Aggregated de-identified data will be available on reasonable request

IPD Sharing Time Frame

Post-study, five years

IPD Sharing Access Criteria

Contact study investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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