Opioidiagonistihoitoa saavien ihmisten toipuminen keskusteluagenttien avulla (SARA RCT)
This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention. The intervention involves an Embodied Conversational Agent (ECA), a virtual, animated computer agent designed to simulate natural face-to-face conversations. ECAs have been shown to help individuals manage their healthcare in other settings, and this study seeks to evaluate their potential in supporting patients on medication for opioid use disorder (MOUD).
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
One hundred participants will be enrolled in the study from the Office-Based Addiction Treatment (OBAT) clinic at Boston Medical Center (BMC). The participants will be randomly assigned to one of two groups. In the intervention group, participants will engage in ECA use and will receive (1) technical support, (2) text message reminders, and (3) monetary incentives. Alternatively, participants will be randomized to the treatment as usual group where they do not access the ECA application. Assessments will be conducted in person at baseline and over the phone at 6 months and 12 months. At 3 and 9 months, research staff will make brief telephone contacts to confirm or update participant contact information. The primary outcome is retention in buprenorphine treatment over 12 months.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Karsten Lunze, MD MPH DrPH
- Puhelinnumero: 617 414 6933
- Sähköposti: karsten.lunze@bmc.org
Tutki yhteystietojen varmuuskopiointi
- Nimi: Samantha Blakemore, MPH
- Puhelinnumero: 617-383-9226
- Sähköposti: samantha.blakemore@bmc.org
Opiskelupaikat
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02118
- Rekrytointi
- Office-Based Addiction Treatment (OBAT) Clinic, BMC
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Ottaa yhteyttä:
- Karsten Lunze, MD MPH DrPH
- Puhelinnumero: 617-414-6933
- Sähköposti: karsten.lunze@bmc.org
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Ottaa yhteyttä:
- Samantha Blakemore, MPH
- Puhelinnumero: 617-383-9226
- Sähköposti: samantha.blakemore@bmc.org
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Diagnosis of Opioid Use Disorder (OUD)
- Within 30 days of intake at recruitment site (BMC OBAT)
- Possession of a smartphone that has minimum requirements
- English-speaking and reading
- Willing to release electronic health record (EHR) data
- Able to provide at least two alternate contacts who usually know how to get in touch with them
- Currently prescribed buprenorphine from an outpatient clinic
Exclusion Criteria:
- Incarceration anticipated within 12 months of enrollment
- Inability to comprehend the study protocol, defined as failing three times to answer correctly a set of questions during the consent process
- Inability to use the ECA app (i.e., due to markedly limited visual or auditory acuity or motor function required to interact with the ECA)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: ECA, technical support, additional ECA messages, and incentives
Participants randomized into the intervention arm will be engaged in ECA use, technical support, additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff, and monetary incentives. |
The app with the ECA will be provided. Technical support will include assistance downloading and setting up the app on the participant's phone, walking them through a brief demonstration, and answering any questions the participant has about how to use the app. Weekly text messages will be provided reminding participants to use the app on behalf of OBAT clinical staff. Additional incentives will be provided after logging into the app for 20 days followed by monthly lotteries for those who log in 15 days per month |
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Ei väliintuloa: Treatment as usual group
Participants randomized into this arm will receive treatment as usual |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of participants that stay engaged in buprenorphine treatment
Aikaikkuna: 12 months
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Engaged in buprenorphine treatment or treatment retention is defined as a participant's treatment period of at least 365 days, including those with multiple disengagement and reengagement periods, as long as any gap in active prescriptions or receipt of injections is less than 60 days. |
12 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Treatment retention at 6 months
Aikaikkuna: 6 months
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Treatment retention is defined as a participant's treatment period of at least 365 days, including those with multiple disengagement and reengagement periods, as long as any gap in active prescriptions or receipt of injections is less than 60 days. |
6 months
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Treatment duration
Aikaikkuna: 6 months. 12 months
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Treatment duration is defined as length of continuous buprenorphine treatment in days until first discontinuation and will be measured via electronic health record (EHR) prescription and injection data and supplemented with self-report. Discontinued buprenorphine treatment occurs once the EHR indicates that they haven't filled a buprenorphine prescription or haven't received a buprenorphine injection in the previous 60 days. The treatment discontinuation date will be the last day of an active prescription or injection received. |
6 months. 12 months
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Opioid use
Aikaikkuna: 6 months
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Opioid use will be measured by self-report via the modified Addiction Severity Index (ASI). The modified ASI is administered by the study staff for a list of 20 drugs/substances. For each the number of days of use and the route of administration of that drug/substance [0=N/A, 1=oral, 2=nasal, 3=smoking, 4=non-intravenous (IV), injection 5=IV, or 8=refused] is documented. |
6 months
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Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)
Aikaikkuna: Baseline, 6 months
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The SU-SMS is a self reported, 18-item instrument. Each item has a 5 Likert frequency responses from 1=Never to 5=Very often. Total scores can range from 1 to 90 or from 1-30 for each of the three types of stigma [anticipated, enacted, and internalized]. Lower scores are correlated with less stigma. |
Baseline, 6 months
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Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)
Aikaikkuna: Baseline, 6 months
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BT-SMS is a self reported, 25-item instrument. Each item has a 5 Likert frequency responses from 1=Never to 5=Very often. Total scores can range from 1 to 125 or from 1-45 for anticipated stigma, 1-45 for enacted stigma, and 1-35 for internalized stigma. Lower scores are correlated with less stigma. |
Baseline, 6 months
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Changes in recovery capital
Aikaikkuna: Baseline, 6 months
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Changes in recovery capital will be measured by self-report via the Brief Assessment of Recovery Capital (BARC-10) which is a 10-item self administered instrument. Each item has 6 Likert possible responses where 1=Strongly disagree to 6=Strongly agree. Total scores can range from 1 to 60. Higher scores are correlated with more recovery capital. |
Baseline, 6 months
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Frequency of interaction with the ECA app
Aikaikkuna: 6 months, 12 months
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Frequency of interactions with the ECA app will be collected via the app itself and provided to the BMC study team by the investigators at Northeastern University. |
6 months, 12 months
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User attitude and satisfaction toward the ECA
Aikaikkuna: 6 months
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User attitudes and satisfaction with the ECA app will be measured by self-report using the Bond subscale of the Working Alliance Inventory which is an investigator developed instrument. The Bond subscale has 6 questions with an analog type response from 'disagree completely' to 'agree completely'. |
6 months
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Karsten Lunze, MD MPH DrPH, Boston Medical Center
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- H-45380
- 1R34DA058124-01A1 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
All data produced in the course of the project will be preserved and shared upon reasonable request.
IPD-jaon aikakehys
Shared data generated from this project will be made available as soon as possible, and no later than at the time of publication. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
IPD-jaon käyttöoikeuskriteerit
Data will be available by controlled access only. To access data users must submit an informal data request and signs BMC's Data Use Agreement (DUA), which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data. To get access to the data, the user must submit a valid scientific question, include a statistical analysis plan. The MPIs will review the data request for scientific merit.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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