Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT06698302

Conditions

Chronic Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Study Details

Brief summary:

Prospective translation validation pilot study that will collect data from Spanish-speaking CP patients seen at Methodist Dallas Medical Center (MDMC) beginning June 2024 through July 2027, in order to validate a Spanish-translated COMPAT-SF instrument.

Conditions

Chronic Pancreatitis

Study ID

NCT06698302

Start date

Sep 13, 2024

Status verified date

Jul, 2024

Completion date

Sep 13, 2026

Anticipated

Primary completion date

Sep 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older in age
  • Have a definite CP diagnosis and a stable pain pattern with no new interventions or medications in the last three months
  • Able to read and understand the study information in Spanish
  • Personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study
  • Subject is willing and able to comply with the scheduled questionnaires

Exclusion Criteria:

  • Subjects who do not meet the criteria in section 4.1

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Questionnaires

Administer translated COMPAT-SF questionnaires to Spanish-speaking CP patients

Primary outcome measure

  • Face validity: [ Time Frame: through study completion, up to 18 months ]

Central Contacts and Locations

Central contacts

Jeff Wilson

2149471279JeffreyWilson@mhd.com

Locations

Methodist Dallas Medical Center- Clinical Research Institute

Recruiting

Dallas, Texas, United States, 75203

More Information

Sponsor

Methodist Health System

Last update posted

Nov 20, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-11-20.