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OpenTrials
Completed

NCT Number: NCT03498690

Protocol Lab for Online Trials-Delphi

The Protocol Lab for Online Trials-Delphi (PLOT-D) module will use an online three-round Delphi combined with Participatory action research to inform the development of a multi-use protocol template to use in writing protocols for self-recruited online trials of interventional self-management. The Delphi will include an embedded randomized controlled trial to test how and if stakeholders adapt their views based on the contributions of others inside or outside the groups with which they are familiar.

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Key information

Conditions

Decisional Variability by Presentation Methods for Consensus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ThinkWell

Oxford, Oxfordshire, OX4 4DN, United Kingdom

About this study

The research aims to provide support for citizens to work alongside researchers to build participatory health trials online (any randomized trial that uses the internet for a health or wellness intervention). Tools to develop methods to run quality online trials protocols are needed. Also, help for adapting guidance to include the public and patients as partners in research for online trials is limited. The purpose of this work is to facilitate improved practice within protocol writing for participatory online trials.

Public and patient involvement (PPI), is one method used to conduct participatory research. PPI actively engages communities or individuals and moves beyond educating, engaging or doing interviews with research participants and does the research with them as partners. There is growing consensus that PPI is of value to researchers, industry, regulators, and members of the public.

There is an active discussion that is without substantial evidence for when the optimal time in the research process is to start PPI and whether patients and the public should join the research team, act as advisors, or have everyone contribute perspectives and work with their roles or peer groups.

The embedded study within the Delphi explores how working with stakeholder feedback in different ways may influence decision ranking as well choice similarities and differences

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None if inclusion criteria are met

Treatment and study plan

Integrative

Behavioral

Stakeholder groups: a-b

Role specific

Behavioral

Stakeholder groups: a or b

Consecutive

Behavioral

Stakeholder groups: a=> b

Primary outcomes

  1. The top five disparities and similarities in ranking between interventions

    Time frame: Up to 20 weeks or study completion

    Prioritization of method preferences as decided by participants

Secondary outcomes

  1. Differences and similarities between stakeholder groups

    Time frame: Up to 20 weeks or study completion

    Ranking differences between stakeholders randomized to different forms of information presentation

Sponsors and collaborators

Lead sponsor

ThinkWell

Other

Registry information

Official study title

Protocol Lab for Online Trials-Delphi (PLOT-D)

Acronym: PLOT-D

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2018
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.