Chronic PancreatitisNCT06698302
Validation of COMPAT-SF Spanish Translation
An observational study of Chronic Pancreatitis, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to 13 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Subjects who do not meet the criteria in section 4.1
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center- Clinical Research Institute
Dallas, Texas, 75203
About this study
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.
Read the detailed description
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
- Being tested
- Questionnaires
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Administer translated COMPAT-SF questionnaires to Spanish-speaking CP patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Face validity:
Patient-reported feedback through a questionnaire concerning the feasibility of the translated COMPAT-SF questionnaire
Measured: through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start13 Sep 2024
- Primary completion13 Sep 2026 (estimated)
- Study completion13 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698302
- Sponsor's protocol ID
- 009.GID.2024.D
- Status last verified
- Jul 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of COMPAT-SF Spanish Translation
- ClinicalTrials.gov ID
- NCT06698302
- Acronym / sponsor ID
- 009.GID.2024.D
- Conditions
- Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 13 Sep 2026 (estimated)
- Study completion
- 13 Sep 2026 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who do not meet the criteria in section 4.1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAdminister translated COMPAT-SF questionnaires to Spanish-speaking CP patients | Behavioural | – |
Primary outcome
Face validity:
Time frame: through study completion, up to 18 months
Patient-reported feedback through a questionnaire concerning the feasibility of the translated COMPAT-SF questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff Wilson (2149471279, JeffreyWilson@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face validity: (time frame: through study completion, up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.