Behavior, AdaptiveNCT03498677
Protocol Lab for Online Trial Delphi and Question Effects
A study testing presentation order and alternative presentation order in people with Behavior, Adaptive and Decision Analysis, run by ThinkWell at 1 site in United Kingdom.
Trial summary
This study nested as a randomized controlled trial within an online Delphi and will assess the impact of using different question section groupings to provide aggregate feedback to participants in an online Delphi study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Adaptive, Decision Analysis
- What is being tested?
- presentation order and alternative presentation order
- 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
- 29 May 2018to 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: Effects of Question Section Order on Prioritization of Items by Stakeholder Groups in an Online Delphi Study
This study nested as a randomized controlled trial within an online Delphi and will assess the impact of using different question section groupings to provide aggregate feedback to participants in an online Delphi study.
Read the detailed description
A similar assessment has been done during the development of a core outcome for critical care trials set with a nested study examining the impact of question order on prioritization of outcomes. Research reports different stakeholders groups may differ in how they value or prioritize research questions and outcomes and it is recommended that each group should be adequately represented.
The Protocol Lab for Online Trials-Delphi (PLOT-D) study will use an online Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.
- Conditions
- Behavior, Adaptive, Decision Analysis
- Being tested
- presentation order, alternative presentation order
- Keywords
- online trial, decision analysis
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presentation orderBehavioural
section presentation one
alternative presentation orderBehavioural
section presentation two
| Study group | Role | What they receive |
|---|---|---|
| Method of presentation one | Active comparator | Not described Receives: Behavioral: presentation order |
| Method of presentation two | Active comparator | Not described Receives: Behavioral: alternative presentation order |
What is being measured
The primary outcome is the main question the study is designed to answer.
Context effects of question order
measure to what extent question section order changes context response between conditions
Measured: Up to 20 weeks or study completion
Secondary outcomes (2)
Question section presentation order
response differences amongst stakeholder groups randomized to 1 of 2 presentation order conditions
Measured: Up to 20 weeks or study completion
Retention
difference in number of items retained at the end of the first Delphi round by randomized assignment to condition
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 start29 May 2018
- Primary completion30 Apr 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Behavior, AdaptiveStudies 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
- 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 Price, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498677
- Sponsor's protocol ID
- PLOT-D Question Effects
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2018
- Last updated
- 22 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 reasonable request
Publications
Brookes ST, Chalmers KA, Avery KNL, Coulman K, Blazeby JM; ROMIO study group. Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial. Trials. 2018 Jan 25;19(1):66. doi: 10.1186/s13063-017-2405-6.
PubMed 29370827Potter S, Brookes ST, Holcombe C, Ward JA, Blazeby JM. Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery. Trials. 2016 Sep 23;17(1):463. doi: 10.1186/s13063-016-1591-y.
PubMed 27664072Snow 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 29062496Sinha 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 29062516Price 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 29076631Altman DG. Practical statistics for medical research. London: Chapman and Hall; 1991
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Question Section Order on Prioritization of Items by Stakeholder Groups in an Online Delphi Study
- ClinicalTrials.gov ID
- NCT03498677
- Acronym / sponsor ID
- PLOT-D Question Effects
- Conditions
- Behavior, Adaptive, Decision Analysis
- Keywords
- online trial, decision analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- ThinkWellUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Apr 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.
This study nested as a randomized controlled trial within an online Delphi and will assess the impact of using different question section groupings to provide aggregate feedback to participants in an online Delphi study.
Detailed description
A similar assessment has been done during the development of a core outcome for critical care trials set with a nested study examining the impact of question order on prioritization of outcomes. Research reports different stakeholders groups may differ in how they value or prioritize research questions and outcomes and it is recommended that each group should be adequately represented.
The Protocol Lab for Online Trials-Delphi (PLOT-D) study will use an online Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Method of presentation one | Active comparator | Behavioral: presentation order |
| Method of presentation two | Active comparator | Behavioral: alternative presentation order |
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 |
|---|---|---|
| presentation ordersection presentation one | Behavioural | Method of presentation one |
| alternative presentation ordersection presentation two | Behavioural | Method of presentation two |
Primary outcome
Context effects of question order
Time frame: Up to 20 weeks or study completion
measure to what extent question section order changes context response between conditions
2 secondary outcomes
Question section presentation order
Time frame: Up to 20 weeks or study completion
Retention
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 22 Mar 2021.
- Background: PubMed 29370827Brookes ST, Chalmers KA, Avery KNL, Coulman K, Blazeby JM; ROMIO study group. Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial. Trials. 2018 Jan 25;19(1):66. doi: 10.1186/s13063-017-2405-6.
- Background: PubMed 27664072Potter S, Brookes ST, Holcombe C, Ward JA, Blazeby JM. Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery. Trials. 2016 Sep 23;17(1):463. doi: 10.1186/s13063-016-1591-y.
- 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 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 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.
- BackgroundAltman DG. Practical statistics for medical research. London: Chapman and Hall; 1991
- Individual participant dataSharing planned: Yes. Aggregated de-identified data will be available on reasonable request
Related trials for Behavior, Adaptive
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Recruiting
Just-in-Time Coping Prompts for Reactive Digital Behavior in College Students
Emotional Regulation, Alcohol Drinking in College
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Recruiting
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Alcohol Abuse, Alcohol Use Disorder
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 Price, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing presentation order and alternative presentation order in people with Behavior, Adaptive and Decision Analysis, 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 22 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?
Context effects of question order (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 NCT03498677, which also lists 9 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 22 Mar 2021.