NCT02122302

Brief Summary

This investigation develops an online, patient self-assessment system, called "CarePrep" to support the care and clinical research of patients with chronic pancreatic disease and chronic pancreatic pain. This web-based assessment presents patients with questions that address medical, psychological, social, behavioral, and quality-of-life issues that are relevant to pancreatic disease. Patients will be given the opportunity to enter and track their symptoms over the Internet from home or clinic. The system is also designed to gather clues to identify neuropathic pain, which occurs when the nervous system fails to properly regulate pain signals. Any of these factors can contribute to chronic pain and may point the way to more effective treatment. The broad objective of this study is to extend CarePrep to cover a full range of topics that are relevant to chronic pancreatic disease. The study team will refine this content based on the system's accuracy in real clinical settings and direct efforts to maximize its feasibility.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

2.1 years

First QC Date

April 22, 2014

Last Update Submit

December 11, 2017

Conditions

Chronic Pancreatitis

Keywords

Altered gastrointestinal anatomyChronic pancreatic diseaseChronic pancreatic painPatient self-assessmentOnline assessment

Outcome Measures

Primary Outcomes (1)

  • Physician and patient evaluation of validity and feasibility of online patient self-assessment system to support integrated gastrointestinal and biopsychosocial care

    Feedback via cognitive and structured interviews will assess validity: Cognitive interviews will probe for CarePrep comprehension and ease of use and will measure patients' rationale for selecting their online responses; structured interviews will include a block of standardized questions mirroring the online CarePrep assessment; patients' interview responses will be compared to data from their online session to assess the sensitivity of CarePrep screening questions; patients' ratings of CarePrep's accuracy will be collected to improve and validate system design; and experts and clinicians will review relevant sections of the CarePrep report for accuracy in order to address the utility and accuracy of reported data.. Physician and patient self-reports will assess feasibility and utility: After the refinement and validation phases have been completed, patients and clinicians will score the usefulness of Careprep in routine clinic use via brief self-reports.

    One year

Study Arms (1)

Web-based health assessment

EXPERIMENTAL
Device: CarePrep Online Health Assessment

Interventions

CarePrep Online Health AssessmentDEVICE

Patients can utilize a web-based self-assessment system to answer questions that address medical, psychological, social, behavioral, and quality-of-life issues that are relevant to pancreatic disease. Patients can enter and track their symptoms over the Internet from home or clinic. The system is also designed to gather clues to identify neuropathic pain, which occurs when the nervous system fails to properly regulate pain signals.

Also known as: Online CarePrep Assessment (OCA)
Web-based health assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be a current or future patient of the Cedars-Sinai Medical Center's Pancreaticobiliary clinic
  • Read English
  • Have access to a computer or touch-screen tablet to complete the online assessment

You may not qualify if:

  • Patients unable or unwilling to complete the online assessment at home or in clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simon K Lo, M.D.

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

  • Stephen J Pandol, M.D.

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 24, 2014

Study Start

May 1, 2014

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

US(1)