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Protocol Lab for Online Trials-Delphi

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03498690
Acronym
PLOT-D
Enrollment
385
Registered
2018-04-17
Start date
2019-03-15
Completion date
2019-10-30
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decisional Variability by Presentation Methods for Consensus

Keywords

online trial, decision analysis

Brief summary

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.

Detailed description

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

Interventions

BEHAVIORALIntegrative

Stakeholder groups: a-b

BEHAVIORALRole specific

Stakeholder groups: a or b

BEHAVIORALConsecutive

Stakeholder groups: a=\> b

Sponsors

ThinkWell
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Randomized 1:1:1 to feedback that is integrative or role specific or presented consecutively

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None if inclusion criteria are met

Design outcomes

Primary

MeasureTime frameDescription
The top five disparities and similarities in ranking between interventionsUp to 20 weeks or study completionPrioritization of method preferences as decided by participants

Secondary

MeasureTime frameDescription
Differences and similarities between stakeholder groupsUp to 20 weeks or study completionRanking differences between stakeholders randomized to different forms of information presentation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026