A Tailored, Web-Based Self-Management Program to Treat Pain in Chronic Pancreatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Web-based self--management program (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Proportion of participants approached that enroll in the study.(Approximately 1 year (during recruitment period))
- Proportion of enrolled participants that log in at least once during the 12-week program(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.(12 weeks)
- Number of logins per participant during the 12-week intervention(12 weeks)
- Proportion of fully completed questionnaires by the total number given to participants(12 weeks)
- Proportion of participants who scores the general acceptability item on the acceptability scale ≥4 out of 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)(12 weeks)
Investigators
Jorge Machicado, MD, MPH
Clinical Associate Professor
University of Michigan