Validation of COMPAT-SF Spanish Translation

NCT06698302 — Unknown, 100 participants, Methodist Health System

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Registry	NCT06698302
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Methodist Health System (Other); collaborators: Aalborg University Hospital
Conditions	Chronic Pancreatitis
Interventions	Questionnaires (Behavioral)
Dates	start 2024-09-13, primary completion 2026-09-13 (estimated), completion 2026-09-13 (estimated), first posted 2024-11-20, last updated 2024-11-20
Locations	1 site in United States

-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.

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+Detailed description

+Arms and interventions

Questionnaires (Behavioral): Administer translated COMPAT-SF questionnaires to Spanish-speaking CP patients

+Outcome measures

Primary outcomes

Face validity: [through study completion, up to 18 months]: Patient-reported feedback through a questionnaire concerning the feasibility of the translated COMPAT-SF questionnaire

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Methodist Dallas Medical Center- Clinical Research Institute	Dallas, Texas	United States	Recruiting