NCT06619431

Brief Summary

The goal of this observational study is to develop and test a mobile app for Spanish speakers residing in the US who seeking drug treatment and/or behavioral health services for themselves or an associate. The main questions it aims to answer are: What are the features and content needed on this app? How will people use and share this app? Will they connect with treatment services? After receiving input from focus group participants and other community stakeholders, the app was made available and its usage was tracked to determine its long-term, broad-scale feasibility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 16, 2024

Last Update Submit

September 25, 2024

Conditions

Keywords

Consumer health informaticsHealth DisparitiesTreatment access for hispanics/latinos

Outcome Measures

Primary Outcomes (1)

  • System Usability Scale

    The system usability scale (SUS) is a ten-item attitude scale giving a global view of subjective assessments of usability.

    From enrollment to the close of end-user testing after 4 weeks.

Study Arms (1)

Focus Group

The group consisted of three subgroups of Spanish-speakers: women, men, and caretakers.

Device: Mobile Application

Interventions

"Rumbo" is an easily shared bi-lingual application that helps Hispanic individuals with unhealthy substance use find and access treatment services and related resources. The application stands out from other eHealth tools by leveraging the collective efficacy of the Hispanic community to overcome barriers and support individuals' self-efficacy for engaging the treatment system. Rumbo's simple, user-centered design provides less-acculturated Hispanic individuals with a culturally appropriate tool to understand their needs within the complex US treatment system. Rumbo is comprised of four innovations: (1) a sharing function that facilitates its own implementation among the target population; (2) culturally responsive content and design; (3) problem identification and treatment navigation enhanced to include related resources; (4) an API that is designed for interoperability across extant technologies.

Focus Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hispanic/Latine community sample

You may qualify if:

  • At least 18 years old
  • Identify as Hispanic/Latino
  • Own a smartphone, pad, or computer
  • Be willing to meet with study personnel more than once

You may not qualify if:

  • Age less than 18 or more than 75
  • Evidence of significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Volver Health

Albuquerque, New Mexico, 87112, United States

Location

Related Links

Study Officials

  • William P Campbell

    Volver Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

October 1, 2024

Study Start

January 1, 2024

Primary Completion

April 2, 2024

Study Completion

April 2, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Data from participants will be reported when the study is published ion a peer-reviewed journal.

Shared Documents
STUDY PROTOCOL
Time Frame
Upon publication in the Spring of 2025, and available indefinitely after that.
Access Criteria
Anyone with access to academic journals may access the data. Also, anyone may write to the study authors to receive a free copy of the published report.

Locations