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Completed

NCT Number: NCT07223554

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

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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Neurologic Manifestations Pain Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Web-based self--management program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 3, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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