Decisional Variability by Presentation Methods for ConsensusPLOT-DNCT03498690
Protocol Lab for Online Trials-Delphi
A study testing Integrative, Role specific and Consecutive in people with Decisional Variability by Presentation Methods for Consensus, run by ThinkWell at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decisional Variability by Presentation Methods for Consensus
- What is being tested?
- Integrative, Role specific and Consecutive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2019to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Protocol lab for online trials Delphi (PLOT-D) participants
Who cannot join
- None if inclusion criteria are met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol Lab for Online Trials-Delphi (PLOT-D)
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
- Being tested
- Integrative, Role specific, Consecutive
- Keywords
- online trial, decision analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntegrativeBehavioural
Stakeholder groups: a-b
Role specificBehavioural
Stakeholder groups: a or b
ConsecutiveBehavioural
Stakeholder groups: a=> b
| Study group | Role | What they receive |
|---|---|---|
| Integrative | Active comparator | Not described Receives: Behavioral: Integrative |
| Role Specific | Active comparator | Not described Receives: Behavioral: Role specific |
| Consecutive | Active comparator | Not described Receives: Behavioral: Consecutive |
What is being measured
The primary outcome is the main question the study is designed to answer.
The top five disparities and similarities in ranking between interventions
Prioritization of method preferences as decided by participants
Measured: 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
Measured: Up to 20 weeks or study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start15 Mar 2019
- Primary completion15 May 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Decisional Variability by Presentation Methods for ConsensusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1:1 to feedback that is integrative or role specific or presented consecutively
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThinkWell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy I Price, PhD, Principal investigator, University of OxfordMike J Clarke, DPhil, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498690
- Sponsor's protocol ID
- PLOT-D Ranking
- Acronym
- PLOT-D
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2018
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated de-identified data will be available on request to principal investigator Amy Price dr.amyprice@gmail.com
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 21283604Fletcher 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 29942546Bagley 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 29062516Snow 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 29062496Price 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Lab for Online Trials-Delphi (PLOT-D)
- ClinicalTrials.gov ID
- NCT03498690
- Acronym / sponsor ID
- PLOT-D / PLOT-D Ranking
- Keywords
- online trial, decision analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- ThinkWellUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized 1:1:1 to feedback that is integrative or role specific or presented consecutively
| Arm | Type | Receives |
|---|---|---|
| Integrative | Active comparator | Behavioral: Integrative |
| Role Specific | Active comparator | Behavioral: Role specific |
| Consecutive | Active comparator | Behavioral: Consecutive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Protocol lab for online trials Delphi (PLOT-D) participants
Key exclusion criteria (1 listed)
- None if inclusion criteria are met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntegrativeStakeholder groups: a-b | Behavioural | Integrative |
| Role specificStakeholder groups: a or b | Behavioural | Role Specific |
| ConsecutiveStakeholder groups: a=> b | Behavioural | Consecutive |
Primary outcome
The top five disparities and similarities in ranking between interventions
Time frame: Up to 20 weeks or study completion
Prioritization of method preferences as decided by participants
1 secondary outcome
Differences and similarities between stakeholder groups
Time frame: Up to 20 weeks or study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 21283604Sinha 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.
- BackgroundFletcher 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: PubMed 29942546Brice 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.
- Background: PubMed 29062516Bagley 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.
- Background: PubMed 29062496Snow 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.
- Background: PubMed 29076631Price 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.
- Individual participant dataSharing planned: Yes. Aggregated de-identified data will be available on request to principal investigator Amy Price dr.amyprice@gmail.com
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy I Price, PhD principal investigator
University of Oxford
Mike J Clarke, DPhil principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative, Role specific and Consecutive in people with Decisional Variability by Presentation Methods for Consensus, run by ThinkWell at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The top five disparities and similarities in ranking between interventions (time frame: Up to 20 weeks or study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498690, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.