Health Disparity, Minority and Vulnerable PopulationsNCT06619431
Pilot Test of a Mobile App That Helps Spanish-speakers Find Mental Health Services in the US.
An observational study of Health Disparity, Minority and Vulnerable Populations, run by Volver Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Disparity, Minority and Vulnerable Populations
- What is being tested?
- Mobile Application
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 2 Apr 2024
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hispanic/Latine community sample
Who may be able to join
- 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
Who cannot join
- Age less than 18 or more than 75
- Evidence of significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rumbo: an Integrated Mobile and Web-Based Application to Overcome Barriers to Receive Substance Use Disorder (SUD) Treatment and Improve Outcomes for Spanish-Speaking, Hispanic and Latinx Individuals
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.
- Being tested
- Mobile Application
- Keywords
- Consumer health informatics, Health Disparities, Treatment access for hispanics/latinos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationDevice
"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.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | The group consisted of three subgroups of Spanish-speakers: women, men, and caretakers. Receives: Device: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
The system usability scale (SUS) is a ten-item attitude scale giving a global view of subjective assessments of usability.
Measured: From enrollment to the close of end-user testing after 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jan 2024
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Disparity, Minority and Vulnerable PopulationsStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volver Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston University, Pacific Institute for Research and Evaluation, National Institute on Drug Abuse (NIDA), National Institute on Drug Abuse (NIDA) (DA038095)
- Responsible party
- Sponsor
- Investigators
- William P Campbell, Principal investigator, Volver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619431
- Sponsor's protocol ID
- R43DA057759
- Other IDs
- 1R43DA057759-01
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from participants will be reported when the study is published ion a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rumbo: an Integrated Mobile and Web-Based Application to Overcome Barriers to Receive Substance Use Disorder (SUD) Treatment and Improve Outcomes for Spanish-Speaking, Hispanic and Latinx Individuals
- ClinicalTrials.gov ID
- NCT06619431
- Acronym / sponsor ID
- R43DA057759
- Keywords
- Consumer health informatics, Health Disparities, Treatment access for hispanics/latinos
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Volver HealthIndustry (pharma, biotech, devices)
- Collaborators
- Boston University, Pacific Institute for Research and Evaluation, National Institute on Drug Abuse (NIDA), National Institute on Drug Abuse (NIDA) (DA038095)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 1 Oct 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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | Device: Mobile ApplicationThe group consisted of three subgroups of Spanish-speakers: women, men, and caretakers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hispanic/Latine community sample
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age less than 18 or more than 75
- Evidence of significant cognitive impairment
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 |
|---|---|---|
| Mobile Application"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. | Device | Focus Group |
Primary outcome
System Usability Scale
Time frame: From enrollment to the close of end-user testing after 4 weeks.
The system usability scale (SUS) is a ten-item attitude scale giving a global view of subjective assessments of usability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Website of Volver Health, who conducted the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from participants will be reported when the study is published ion a peer-reviewed journal.
Related trials for Health Disparity, Minority and Vulnerable Populations
RecruitingObservational study
Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Mental Health, Child Wellbeing
Recruiting
Rhode Island Community-based Maternal Support Services
Perinatal Outcomes, Social Determinants of Health (SDOH)
Recruiting
Teen Mom Study Feasibility Trial
Physical Activity, Sedentary Behavior
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.
William P Campbell principal investigator
Volver Health
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 Health Disparity, Minority and Vulnerable Populations, run by Volver Health 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: From enrollment to the close of end-user testing after 4 weeks.). 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 1 Oct 2024.