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

ThinkWell

Status: Completed

Conditions: Decisional Variability by Presentation Methods for Consensus

Treatments: Behavioral: Integrative; Behavioral: Role specific; Behavioral: Consecutive

Study type: Interventional

Funder types: Other

Identifiers

NCT03498690

PLOT-D Ranking

Details and patient eligibility

About

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.

Full 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

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None if inclusion criteria are met

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 3 patient groups

Integrative

Active Comparator group

Treatment:

Behavioral: Integrative

Role Specific

Active Comparator group

Treatment:

Behavioral: Role specific

Consecutive

Active Comparator group

Treatment:

Behavioral: Consecutive