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CompletedNCT03498690PLOT-DUpdated Mar 23, 2021

Protocol Lab for Online Trials-Delphi

An interventional study of Integrative and Role specific in Decisional Variability by Presentation Methods for Consensus, sponsored by ThinkWell. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-23.

Sponsored by ThinkWell · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
385
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Decisional Variability by Presentation Methods for Consensus

Keywords

  • online trial
  • decision analysis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None if inclusion criteria are met
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
385 participants (actual)

Study arms

  • Active comparator
    Integrative

    Behavioral: Integrative

  • Active comparator
    Role Specific

    Behavioral: Role specific

  • Active comparator
    Consecutive

    Behavioral: Consecutive

Interventions

  • BehavioralIntegrative

    Stakeholder groups: a-b

  • BehavioralRole specific

    Stakeholder groups: a or b

  • BehavioralConsecutive

    Stakeholder groups: a=\> b

05

What researchers measure

Primary outcomes

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

    Prioritization of method preferences as decided by participants

    Time frame: Up to 20 weeks or study completion

Secondary outcomes

  1. Differences and similarities between stakeholder groups

    Ranking differences between stakeholders randomized to different forms of information presentation

    Time frame: Up to 20 weeks or study completion

06

Study locations

1 site
  • ThinkWell
    Oxford, Oxfordshire OX4 4DN, United Kingdom
07

References and documents

Publications

  • Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan 25;8(1):e1000393. doi: 10.1371/journal.pmed.1000393. PubMed 21283604 ↗
  • Fletcher AJ, Marchildon GP. Using the Delphi Method for Qualitative, Participatory Action Research in Health Leadership. International Journal of Qualitative Methods 2014;13:1-18
  • Brice A, Price A, Burls A. Creating a database of internet-based clinical trials to support a public-led research programme: A descriptive analysis. Digit Health. 2015 Nov 20;1:2055207615617854. doi: 10.1177/2055207615617854. eCollection 2015 Jan-Dec. PubMed 29942546 ↗
  • Bagley HJ, Short H, Harman NL, Hickey HR, Gamble CL, Woolfall K, Young B, Williamson PR. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress. Res Involv Engagem. 2016 Apr 27;2:15. doi: 10.1186/s40900-016-0029-8. eCollection 2016. PubMed 29062516 ↗
  • Snow R, Crocker JC, Crowe S. Missed opportunities for impact in patient and carer involvement: a mixed methods case study of research priority setting. Res Involv Engagem. 2015 Aug 4;1:7. doi: 10.1186/s40900-015-0007-6. eCollection 2015. PubMed 29062496 ↗
  • Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, Burls A. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. J Eval Clin Pract. 2018 Feb;24(1):240-253. doi: 10.1111/jep.12805. Epub 2017 Oct 27. PubMed 29076631 ↗

Individual participant data

Plan to share: Yes — Aggregated de-identified data will be available on request to principal investigator Amy Price dr.amyprice@gmail.com

Supporting information: Study protocol, Icf

08

Registry details

Key details

Study ID
NCT03498690
Lead sponsor
ThinkWell
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
Mar 15, 2019
Primary completion
May 15, 2019
Completion
Oct 30, 2019
Last update
Mar 23, 2021

Study contacts

Amy I Price, PhD
principal investigator · University of Oxford
Mike J Clarke, DPhil
principal investigator · Queen's University, Belfast

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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