ConstipationNCT06352827
Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
A study testing Survey in people with Constipation, run by University of Michigan at 1 site in United States.
Trial summary
The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 8 Aug 2025
- Phase
- Interventional
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
- Participant has Chronic constipation as a main symptom
- Participant is able to participate in pelvic floor physical therapy
Who cannot join
- Participant has taken narcotic pain medication in the past 30 days
- Participant has been scheduled for a test called an anorectal manometry in the past
- Participant has been scheduled to see a pelvic floor physical therapist in the past
- Participant is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation.
Read the detailed description
Per the NIH requirements the study team added the following language and also updated the registration to be an interventional study. The study will enroll adult patients with chronic constipation prior to appointment with a gastroenterologist that have not received anorectal function testing or treatment in the past. The study team will assess patients' constipation symptoms and then monitor whether providers order anorectal function testing or treatment as a primary outcome. Source data will be derived from the medical record to provide quality assurance. The sample size is necessary to evaluate this outcome measure while accounting for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results. The statistical analysis plan will be descriptive with reporting of our binary primary endpoints given the nature of this being a pilot study.
Registration NCT07032376 (Implementation Phase) is part of this registration, "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.
- Conditions
- Constipation
- Being tested
- Survey
- Keywords
- Questionnaires, Gastroenterology care
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
All participants will complete a baseline survey and have medical information collected.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Other | This cohort will complete a baseline survey. Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity to Ordering Pelvic Floor Diagnostics and/or Treatment
Results reflect the number of participants for whom anorectal physiology testing and/or pelvic floor physical therapy was ordered or performed at the baseline routine-care gastroenterology office appointment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start30 Jul 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be enrolled in the observational intervention group first.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Shah, University of Michigan
- Investigators
- Eric Shah, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352827
- Sponsor's protocol ID
- HUM00228948
- Other IDs
- 1K23DK134752-01
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2024
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No