Chronic PancreatitisNCT07223554
A Tailored, Web-Based Self-Management Program to Treat Pain in Chronic Pancreatitis
A study testing Web-based self--management program in people with Chronic Pancreatitis, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Web-based self--management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to 28 Apr 2026
- 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
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Web-based self--management program
- Keywords
- Behavioral intervention, Self-management, Pain
- Medical subject headings
- Pancreatitis, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based self--management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based self-management program | Experimental | 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. Receives: Behavioral: Web-based self--management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
This number is used to determine adherence to the intervention.
Measured: 12 weeks
Proportion of participants with an average item score of ≥4 out of 5 on the Acceptability of Healthcare Interventions Questionnaire
This is a validated 8-item questionnaire that assesses acceptability using a 5-point Likert scale rated 1-5.
Measured: 12 weeks
Secondary outcomes (7)
Proportion of participants approached that enroll in the study.
This number is used to determine enrollment feasibility to the web-based program in patients with painful CP.
Measured: Approximately 1 year (during recruitment period)
Proportion of enrolled participants that log in at least once during the 12-week program
This number is used to determine minimal adherence to the web-based program in patients with painful CP.
Measured: 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.
This number is used to determine maximal adherence to the web-based program in patients with painful CP.
Measured: 12 weeks
Number of logins per participant during the 12-week intervention
This number is used to determine engagement with the web-based program in patients with painful CP.
Measured: 12 weeks
Proportion of fully completed questionnaires by the total number given to participants
This number is used to assess the feasibility of data collection procedures.
Measured: 12 weeks
Proportion of participants who scores the general acceptability item on the acceptability scale ≥4 out of 5
This is a validated 8-item questionnaire that assesses acceptability using a 5-point Likert scale rated 1-5.
Measured: 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)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start4 Dec 2025
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Machicado, MD, MPH, University of Michigan
- Investigators
- Jorge Machicado, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223554
- Sponsor's protocol ID
- HUM00277458
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2025
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored, Web-Based Self-Management Program to Treat Pain in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT07223554
- Acronym / sponsor ID
- HUM00277458
- Conditions
- Chronic Pancreatitis
- Keywords
- Behavioral intervention, Self-management, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 3 Nov 2025 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based self-management program | Experimental | Behavioral: Web-based self--management programParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Web-based self--management programParticipants 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. | Behavioural | Web-based self-management program |
Primary outcome
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.
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.
7 secondary outcomes
Proportion of participants approached that enroll in the study.
Time frame: 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
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
Number of logins per participant during the 12-week intervention
Time frame: 12 weeks
Proportion of fully completed questionnaires by the total number given to participants
Time frame: 12 weeks
Proportion of participants who scores the general acceptability item on the acceptability scale ≥4 out of 5
Time frame: 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
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 1 May 2026.
- 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.
Jorge Machicado, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based self--management program in people with Chronic Pancreatitis, run by University of Michigan 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 3 inclusion and 9 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 1 May 2026. 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?
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). The study lists 2 primary outcomes in all. 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 1 May 2026.