A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

NCT ID: NCT07032376

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-20

Study Completion Date

2027-02-28

Brief Summary

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This research is studying how the availability of a Food and Drug Administration (FDA)-cleared point-of-care, bedside device bedside device called Rectal Expulsion Device (RED) can be used to evaluate constipation in the participants' routine office visit with the participants' care provider. In this research, participants will be asked to complete a survey prior to the gastroenterology office consultation. Health-related information will be collected for this research study. There are no additional study visits for this research study.

Detailed Description

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This registration is (Implementation Phase) for the registered study "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.

Conditions

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Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Chronic constipation

Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.

Group Type EXPERIMENTAL

Survey

Intervention Type BEHAVIORAL

All participants will complete a baseline survey and have medical information collected.

Rectal Expulsion Device use

Intervention Type BEHAVIORAL

During the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit.

In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED.

Interventions

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Survey

All participants will complete a baseline survey and have medical information collected.

Intervention Type BEHAVIORAL

Rectal Expulsion Device use

During the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit.

In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participant has Chronic constipation as a main symptom
* Participant is able to participate in pelvic floor physical therapy

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Eric Shah

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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1K23DK134752-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00228948b

Identifier Type: -

Identifier Source: org_study_id

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