A Tailored, Web-Based Self-Management Program to Treat Pain in Chronic Pancreatitis

April 29, 2026 updated by: Jorge Machicado, MD, MPH, University of Michigan
This research study aims to evaluate the feasibility and acceptability of a web-based, self-guided, disease-specific self-management program tailored to individual health status profiles for patients with painful chronic pancreatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center, prospective, open-label, pilot trial of 30 patients with painful chronic pancreatitis (CP). Participants will be assigned to a 12-week web-based, self-management program known as PainGuide that has been adapted to CP. Participants will receive specific instruction to complete one module a week over the first 4 weeks. Next, participants will receive weekly tailored messaging for the last 8 weeks using symptom scores from baseline assessments and will be asked to complete modules that best address participants symptoms. Participants will complete online surveys at baseline, 4 weeks, 8 weeks, and 12 weeks, and will be interviewed at the end of program to understand participants perceptions on the intervention.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physician diagnosis of chronic pancreatitis.
  • Abdominal pain for ≥ 3 months and of intensity rated at least 4 or higher on a 0-10 Numeric Rating Scale at least once in the last month.
  • Access to an Internet-connected device (e.g. computer or phone).

Exclusion Criteria:

  • Unable to speak or read English as the web-based program is currently in English language only.
  • Incarcerated individuals.
  • Currently receiving chemotherapy.
  • Suspected or diagnosed pancreatic cancer.
  • Currently receiving psychotherapy or cognitive behavioral therapy.
  • Serious visual difficulties that would limit completing the web-based program.
  • Substantial cognitive impairment or mental illness that would prevent providing informed consent and completion of questionnaires.
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study.
  • Actively enrolled in another clinical trial for chronic pancreatitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Web-based self-management program
Participants will be assigned to a web-based, self-management program that has been adapted to chronic pancreatitis. Participants will participate in this program for 12 weeks.
Behavioral: Web-based self--management program
Participants in this study will be granted access to the adapted website after participants complete baseline questionnaires. All participants will be encouraged to engage with all the sections of the website. From week 1 to 4, participants will receive a single standardized guidance to complete one module a week on generic pain modules. From weeks 5 to 12, participants will receive weekly tailored messaging that will direct participants to specific modules based on individual survey scores from the baseline assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of enrolled participants that log in at least once during weeks 1-4 and at least once to the recommended modules during weeks 5-12.
Time Frame: 12 weeks
This number is used to determine adherence to the intervention.
12 weeks
Proportion of participants with an average item score of ≥4 out of 5 on the Acceptability of Healthcare Interventions Questionnaire
Time Frame: 12 weeks
This is a validated 8-item questionnaire that assesses acceptability using a 5-point Likert scale rated 1-5.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants approached that enroll in the study.
Time Frame: Approximately 1 year (during recruitment period)
This number is used to determine enrollment feasibility to the web-based program in patients with painful CP.
Approximately 1 year (during recruitment period)
Proportion of enrolled participants that log in at least once during the 12-week program
Time Frame: 12 weeks
This number is used to determine minimal adherence to the web-based program in patients with painful CP.
12 weeks
Proportion of enrolled participants that log in at least once a week during weeks 1-4 and at least once a week to the recommended modules during weeks 5-12.
Time Frame: 12 weeks
This number is used to determine maximal adherence to the web-based program in patients with painful CP.
12 weeks
Number of logins per participant during the 12-week intervention
Time Frame: 12 weeks
This number is used to determine engagement with the web-based program in patients with painful CP.
12 weeks
Proportion of fully completed questionnaires by the total number given to participants
Time Frame: 12 weeks
This number is used to assess the feasibility of data collection procedures.
12 weeks
Proportion of participants who scores the general acceptability item on the acceptability scale ≥4 out of 5
Time Frame: 12 weeks
This is a validated 8-item questionnaire that assesses acceptability using a 5-point Likert scale rated 1-5.
12 weeks
Proportion of participants that feel the web-based program is easy and intuitive to use based on a usability score > 68 on the System Usability Scale (SUS)
Time Frame: 12 weeks
This is a validated 10-item questionnaire that measures the perceived usability of a system focusing on ease of use, efficiency, and overall satisfaction. Participants score from 1 (strongly disagree) to 5 (strongly agree). To calculate the SUS score, respondents' ratings are adjusted: subtract 1 from the score for odd-numbered items and subtract each score from 5 for even-numbered items. The adjusted scores are then summed and multiplied by 2.5, yielding a total score ranging from 0 to 100. Generally, a SUS score above 68 indicates above-average usability, though this benchmark can vary with different systems.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Jorge Machicado, MD, MPH, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2025

Primary Completion (Actual)

April 28, 2026

Study Completion (Actual)

April 28, 2026

Study Registration Dates

First Submitted

October 29, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Actual)

November 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00277458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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