Cross-cultural Adaptation and Translation Validation of the iADH Universal Case Mix Tool (UCMT). (CCV UCMT)

March 24, 2026 updated by: Sebastian Veliz, Sigmund Freud PrivatUniversitat

This study aims to translate, culturally adapt, and validate the iADH Universal Case Mix Tool (UCMT) for dental care professionals working with people with disabilities.

The study will assess linguistic accuracy, applicability, and reliability/validity of the German, Spanish and Portuguese version of the instrument.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

This study is a multicentre, non-interventional methodological study aimed at translating, culturally adapting, and validating the iADH Universal case mix tool (UCMT) for use by dental care professionals working with people living with disabilities, following international guidelines for cross-cultural adaptation of measurement instruments. The translation and cultural adaptation process will include forward and backward translations of the original UCMT (English) to German, Spanish and Portuguese. Two independent forward translations will be performed for each language, followed by reconciliation into a single version, based on semantic equivalence, clarity and cultural appropriateness. Blinded backward translations into English will then be conducted to ensure conceptual consistency with the original instrument. A panel of experts, composed of dental experts and linguistic professionals fluent in both languages will review all translated versions using a Delphi approach. Later, the adapted instruments will be reviewed by the original UCMT developers for the final approval. Consent Validity Index (CVI) of the translated UCMT will be evaluated through expert ratings and cognitive interviews with dental professionals experienced in special care dentistry. Following the experts' validation, a pilot reliability phase will be conducted using standardised online clinical cases developed for the original versions of the UCMT. Participating raters will complete an online questionnaire using the translated UCMT. Intra and interrater agreement will be assessed to evaluate consistency of the translated instrument in a simulated clinical scenario. This study does not involve real patients of the collection of sensitive personal data.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Vienna
      • Vienna, Vienna, Austria, 1020
        • SFU - Online questionnaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inclusion Criteria:

  • Special care dentist
  • Native in German, Spanish or Portuguese
  • Agree to participate, complete the instrument 2 times

Description

Inclusion Criteria:

  • Special care dentist
  • Native in German, Spanish or Portuguese
  • Agree to participate, complete the instrument 2 times

Exclusion Criteria:

  • Not meeting the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
special care dentists - spanish
Special Care Dentistry Specialist, native Spanish speaker
Special care dentists - german
Special Care Dentistry Specialist, native German speaker
Special care dentists - Portuguese
Special Care Dentistry Specialist, native Portuguese speaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content validity of the translated UCMT
Time Frame: 1 week
Content validity of the UCMT will be assessed by a panel of multidisciplinary experts, assessing clarity, relevance and cultural appropriateness. Experts ratings will be used to calculate Content Validity Index (CVI) for the translated versions of the UCMT. Unit of measure: CVI (Range 0-1)
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interrater agreement of the UCMT domains scores
Time Frame: 1 month

Interrater agreement will be assessed based on scores assigned to the seven domains of the UCMT in the original version and validation. Raters will independently evaluate standardised online cases using the translated versions of the UCMT. Agreement between raters will be quantified for each UCMT domain.

Unit of measure:

Interclass correlation coefficient (range 0-1)
1 month
Temporal stability (Test-retest) of UCMT domain scores
Time Frame: 2 weeks

Intrarater agreement (Temporal stability) will be assessed based on scores assigned to the seven domains of the UCMT in the original version and validation. Raters will independently evaluate standardised online cases using the translated versions of the UCMT on two occasions separated by 1-2 weeks . Agreement between these occasions will be quantified for each UCMT domain.

Unit of measure:

Interclass correlation coefficient (range 0-1)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sigmund Freud PrivatUniversitat

Collaborators

University of Chile
University of Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17793138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not necessary

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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