- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07724275
Understanding Pathways to Wellness and Recovery in Detroit - Digital Recovery Support Services (UPWARD D-RSS)
UPWARD Study RCT of Digital Recovery Support Services (D-RSS) Among a Black Population in Recovery From Alcohol Use Disorders
The goal of this clinical trial is to learn if digital recovery support services (such as smartphone app) help to support alcohol recovery. We focus on a community of Black and African American people with alcohol use disorder (AUD) who receive in-person recovery support services from a recovery community center.
Participants will:
- Have an initial 2-hour in-person visit with the research team. During this visit, participants will be asked about themselves and their recovery from alcohol problems. They will also learn about digital recovery resources.
- Use digital recovery resources on their own for 12 weeks.
- Complete a short, weekly survey about their experience using digital recovery resources.
- Have a follow-up 1-hour in-person visit where the researcher asks about again about the participants, their recovery and how they felt about using the digital recovery support services.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Audrey Hildebrandt
- Telefonnummer: 781-736-8657
- E-post: ahildebrandt@brandeis.edu
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48208
- Rekruttering
- Detroit Recovery Project
-
Ta kontakt med:
- Research Manager
- Telefonnummer: 355 313-365-3100
- E-post: upwardproject@brandeis.edu
-
Ta kontakt med:
- Senior Project Manager
- Telefonnummer: 781-736-8657
- E-post: ahildebrandt@brandeis.edu
-
Hovedetterforsker:
- Sharon Reif, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Able to communicate in English and read at an 8th grade reading level.
- Able to read and sign an informed consent form.
- Comfortable with smartphone technology or willing and able to learn.
- Identify as Black or African American.
- Is an adult over the age of 18.
- Is in recovery from alcohol problems for at least 3 months and no more than 5 years.
- Is receiving in-person recovery support services at our partner recovery community center at the time of screening and enrollment.
- Willing to receive and respond to weekly texts with a survey link for brief assessments, and complete two in-person research assessments (baseline and 13-week).
Exclusion Criteria:
Does not meet inclusion criteria
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: TAU + DRSS
At the initial in-person visit, participants will complete a structured interview of baseline assessments and will be provided with a menu of digital recovery support services (D-RSS) to participants, technical assistance, and a phone and data plan (if needed).
The research team will discuss the D-RSS menu with the participants and guide them through app installation and use.
Following the initial visit, it is up to the participants to engage with the D-RSS.
We will send a text survey 1 week after the visit, and each week thereafter for 12 weeks, that assesses their engagement with in-person recovery supports, D-RSS, and their current recovery status.
The 3-month visit will be scheduled in the week following the last (week 12) text survey, at which participants will meet with research staff for a final in-person assessment.
|
The primary intervention is the provision of a menu of digital recovery support services (D-RSS) to participants, along with a phone and data plan (if needed) and technical assistance.
We have created a menu of D-RSS options that have been vetted by our team as appropriate for a range of recovery goals (e.g., manage emotions, track sobriety, connect with others) and for a range of technological literacy, as well as being culturally relevant or at minimum culturally agnostic.
Types of D-RSS presented to participants include mobile applications, websites, and video playlists, all of which relate to and support addiction recovery.
Participants also may use other D-RSS that they identify.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Usability and Acceptability of D-RSS
Tidsramme: At the end of the trial (13 weeks)
|
We include a module consisting of 20 items measuring usability and acceptability on a 4-point Likert scale (strongly disagree, disagree, agree, strongly agree).
These items were selected from several sources, so do not have a pre-existing scale; we will consider whether a scale is appropriate by examining inter-item correlations and Cronbach's alphas for potentially conceptually similar subsets of items.
|
At the end of the trial (13 weeks)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sharon Reif, PhD, Brandeis University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22126R
- R01AA029817 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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