Pediatric Crohn's DiseaseNCT02869880
Trial of Enhanced Pre-Consent Discussion
A study testing Enhanced Pre-Consent Discussion and Standard Pre-consent Discussion in people with Pediatric Crohn's Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients > 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pediatric Crohn's Disease
- What is being tested?
- Enhanced Pre-Consent Discussion and Standard Pre-consent Discussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent of a child who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
- Patient who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients > 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.
- Conditions
- Pediatric Crohn's Disease
- Being tested
- Enhanced Pre-Consent Discussion, Standard Pre-consent Discussion
- Medical subject headings
- Pediatric Crohn's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Pre-Consent DiscussionOther
The enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff.
Standard Pre-consent DiscussionOther
Standard pre-consent discussion for a clinical trial
| Study group | Role | What they receive |
|---|---|---|
| Standard Pre-consent Discussion | Active comparator | Standard pre-consent discussion for a clinical trial. Receives: Other: Standard Pre-consent Discussion |
| Enhanced Pre-consent Discussion | Experimental | The enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff. Receives: Other: Enhanced Pre-Consent Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Related to Trial Participation
Number correct on 5-item Knowledge Related to Trial Participation survey
Measured: prior to consent
Secondary outcomes (2)
Rate of enrollment
Measured: at consent
Support subscale of decision conflict scale
Measured: prior to consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, ImproveCareNow (ICN), University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Ellen A. Lipstein MD, MPH, Children's Hospital Medical Center, Cincinnati
- Investigators
- Ellen Lipstein, MD, MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869880
- Sponsor's protocol ID
- 2015-9033
- Status last verified
- Jan 2020
- First submitted
- 10 Aug 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Enhanced Pre-Consent Discussion
- ClinicalTrials.gov ID
- NCT02869880
- Acronym / sponsor ID
- 2015-9033
- Conditions
- Pediatric Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, ImproveCareNow (ICN), University of North Carolina, Chapel Hill
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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.
Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients > 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Pre-consent Discussion | Active comparator | Other: Standard Pre-consent DiscussionStandard pre-consent discussion for a clinical trial. |
| Enhanced Pre-consent Discussion | Experimental | Other: Enhanced Pre-Consent DiscussionThe enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parent of a child who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
- Patient who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| Enhanced Pre-Consent DiscussionThe enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff. | Other | Enhanced Pre-consent Discussion |
| Standard Pre-consent DiscussionStandard pre-consent discussion for a clinical trial | Other | Standard Pre-consent Discussion |
Primary outcome
Knowledge Related to Trial Participation
Time frame: prior to consent
Number correct on 5-item Knowledge Related to Trial Participation survey
2 secondary outcomes
Rate of enrollment
Time frame: at consent
Support subscale of decision conflict scale
Time frame: prior to consent
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 18 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Ellen Lipstein, MD, MPH principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Pre-Consent Discussion and Standard Pre-consent Discussion in people with Pediatric Crohn's Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 2 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 18 Jan 2020. 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 States. 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?
Knowledge Related to Trial Participation (time frame: prior to consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.