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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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 | This is a validated 8-item questionnaire that assesses acceptability using a 5-point Likert scale rated 1-5. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 1 year (during recruitment period) |
| Proportion of enrolled participants that log in at least once during the 12-week program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Machicado, MD, MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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|
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. | 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 | 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 | 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 | 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) | 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |