NCT03879785

Brief Summary

This Phase 1 STTR project will develop a technology platform for delivering the TAPS Tool to a Spanish-speaking, health disparity population in a community health center. This will involve the adaptation of the TAPS into Spanish, its deployment on a self-administered mobile/tablet technology platform, and an empirical study of its preliminary validity, feasibility, and acceptability in a Spanish-speaking primary care sample. The investigators refer to this novel adaptation of the TAPS Tool as the TAPS-Electronic Spanish Platform, or TAPS-ESP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

March 12, 2019

Last Update Submit

August 19, 2019

Conditions

Keywords

TobaccoAlcoholPrescription DrugIllicit Substance UseScreeningSpanishHispanic

Outcome Measures

Primary Outcomes (3)

  • Translation of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool (TAPS Tool)

    To conduct a research-driven translation and adaptation of the TAPS Tool into a Spanish-language, self-administered mobile/tablet platform (TAPS-ESP), informed by cognitive interviews with 10 Spanish-speaking primary care patients.

    Estimated 4 Month

  • Preliminary Examination of the translated Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)

    To conduct a preliminary examination of the validity of the TAPS-ESP with 100 Spanish-speaking primary care patients, compared to established Spanish-language reference standard measures

    Estimated 4 Month

  • Feasibility and Acceptability of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)

    To determine the (a) feasibility and (b) acceptability of the TAPS-ESP (including patient perspectives and preferences regarding TAPS-ESP integration with electronic health records) among Spanish-speaking adult primary care patients, using a brief survey with the 100 participants in the validation study.

    Estimated 4 Months

Study Arms (2)

Self-Administration followed by Interviewer-Administered

ACTIVE COMPARATOR
Other: Screening

Interviewer-Administered followed by Self-Administration

ACTIVE COMPARATOR
Other: Screening

Interventions

Screening and validation of assessment tool translated into Spanish

Interviewer-Administered followed by Self-AdministrationSelf-Administration followed by Interviewer-Administered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • A patient at the established clinic site
  • Spanish-language dominant (with ability to read Spanish)

You may not qualify if:

  • Unable to provide informed consent (e.g., due to acute impairment or psychosis)
  • Inability to comprehend or read Spanish
  • Inability to self-administer the iPad tool due to physical limitations
  • Previously enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Scott & White Research Institiute

Dallas, Texas, 75204, United States

Location

Related Publications (1)

  • Sanchez K, Gryczynski J, Carswell SB, Schwartz RP. Development and Feasibility of a Spanish Language Version of the Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use (TAPS) Tool. J Addict Med. 2021 Jan-Feb 01;15(1):61-67. doi: 10.1097/ADM.0000000000000699.

MeSH Terms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 19, 2019

Study Start

March 14, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations