Validation of COMPAT-SF Spanish Translation

NCT06698302 | Recruiting

• 1 other identifier: 009.GID.2024.D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Face validity:

  Patient-reported feedback through a questionnaire concerning the feasibility of the translated COMPAT-SF questionnaire

  through study completion, up to 18 months

Interventions

Questionnaires BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spanish speaking subjects with CP diagnosis and a stable pain pattern with no new interventions or medications in the last three months

You may qualify if:

• 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

You may not qualify if:

• Subjects who do not meet the criteria in section 4.1

Sponsors & Collaborators

• Methodist Health System: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Methodist Dallas Medical Center- Clinical Research Institute

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jeff Wilson

CONTACT

2149471279; JeffreyWilson@mhd.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): September 13, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-07

Locations

US (1)