NCT03498690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

April 1, 2018

Last Update Submit

March 19, 2021

Conditions

Decisional Variability by Presentation Methods for Consensus

Keywords

online trialdecision analysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Differences and similarities between stakeholder groups

    Up to 20 weeks or study completion

Study Arms (3)

Integrative

ACTIVE COMPARATOR
Behavioral: Integrative

Role Specific

ACTIVE COMPARATOR
Behavioral: Role specific

Consecutive

ACTIVE COMPARATOR
Behavioral: Consecutive

Interventions

IntegrativeBEHAVIORAL

Stakeholder groups: a-b

Integrative
Role specificBEHAVIORAL

Stakeholder groups: a or b

Role Specific
ConsecutiveBEHAVIORAL

Stakeholder groups: a=\> b

Consecutive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ThinkWell

Oxford, Oxfordshire, OX4 4DN, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 21283604BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 29942546BACKGROUND

  • 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.

    PMID: 29062516BACKGROUND

  • 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.

    PMID: 29062496BACKGROUND

  • 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.

    PMID: 29076631BACKGROUND

Study Officials

  • Amy I Price, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Mike J Clarke, DPhil

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized 1:1:1 to feedback that is integrative or role specific or presented consecutively
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2018

First Posted

April 17, 2018

Study Start

March 15, 2019

Primary Completion

May 15, 2019

Study Completion

October 30, 2019

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
following publication and for 5 years
Access Criteria
email investigator dr.amyprice@gmail.com

Locations

GB(1)