Protocol Lab for Online Trials-Delphi

Study Overview
=================
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

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

Conditions
-----------------
Decisional Variability by Presentation Methods for Consensus

Intervention / Treatment
-----------------
* Behavioral: Integrative
* Behavioral: Role specific
* Behavioral: Consecutive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Protocol lab for online trials Delphi (PLOT-D) participants Exclusion Criteria: None if inclusion criteria are met

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 1:1:1 to feedback that is integrative or role specific or presented consecutively
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integrative<br> | Behavioral: Integrative<br>* Stakeholder groups: a-b<br>|
| Active Comparator: Role Specific<br> | Behavioral: Role specific<br>* Stakeholder groups: a or b<br>|
| Active Comparator: Consecutive<br> | Behavioral: Consecutive<br>* Stakeholder groups: a=> b<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The top five disparities and similarities in ranking between interventions | Prioritization of method preferences as decided by participants | Up to 20 weeks or study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences and similarities between stakeholder groups | Ranking differences between stakeholders randomized to different forms of information presentation | Up to 20 weeks or study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
online trial, decision analysis