- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06732596
대화형 에이전트를 사용하여 오피오이드 작용제 치료를 받는 사람들의 회복 유지 (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).
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Karsten Lunze, MD MPH DrPH
- 전화번호: 617 414 6933
- 이메일: karsten.lunze@bmc.org
연구 연락처 백업
- 이름: Samantha Blakemore, MPH
- 전화번호: 617-383-9226
- 이메일: samantha.blakemore@bmc.org
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02118
- 모병
- Office-Based Addiction Treatment (OBAT) Clinic, BMC
-
연락하다:
- Karsten Lunze, MD MPH DrPH
- 전화번호: 617-414-6933
- 이메일: karsten.lunze@bmc.org
-
연락하다:
- Samantha Blakemore, MPH
- 전화번호: 617-383-9226
- 이메일: samantha.blakemore@bmc.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
간섭 없음: Treatment as usual group
Participants randomized into this arm will receive treatment as usual |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants that stay engaged in buprenorphine treatment
기간: 12 months
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment retention at 6 months
기간: 6 months
|
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
|
|
Treatment duration
기간: 6 months. 12 months
|
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
|
|
Opioid use
기간: 6 months
|
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
|
|
Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)
기간: Baseline, 6 months
|
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
|
|
Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)
기간: Baseline, 6 months
|
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
|
|
Changes in recovery capital
기간: Baseline, 6 months
|
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
|
|
Frequency of interaction with the ECA app
기간: 6 months, 12 months
|
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
|
|
User attitude and satisfaction toward the ECA
기간: 6 months
|
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Karsten Lunze, MD MPH DrPH, Boston Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-45380
- 1R34DA058124-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All data produced in the course of the project will be preserved and shared upon reasonable request.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .