Validation of COMPAT-SF Spanish Translation | NCT06698302

Studies
Validation of COMPAT-SF Spanish Translation

NCT06698302

Sponsor

Methodist Health System

Status

Recruiting

Last Update Posted

Nov 20, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Pancreatitis

Interventions

Questionnaires

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2024Actual

Primary Completion Date

Sep 13, 2026Estimated

Completion Date

Sep 13, 2026Estimated

First Submitted Date

Nov 18, 2024

First Submission Date that Met QC Criteria

Nov 18, 2024

First Posted Date

Nov 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2024

Last Update Posted Date

Nov 20, 2024Actual

Name	Class
Aalborg University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Behavioral	Administer translated COMPAT-SF questionnaires to Spanish-speaking CP patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeff Wilson	Contact	2149471279		JeffreyWilson@mhd.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center- Clinical Research Institute	Recruiting	Dallas	Texas	75203	United States

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided