- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03411265
RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing (RETAIN)
Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing Through Active Patients Sharing Experiences and the Provision of Information About Infections -an electroNic-health Application
The purpose of this research study is to:
- assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
- test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
- assess treatment retention rates in patients completing the RETAIN intervention.
- test the impact of RETAIN on knowledge about HCV/HIV
- test the impact of RETAIN on interest in being tested for HCV/HIV
연구 개요
상태
상세 설명
The pre-post study of RETAIN will: 1) assess the acceptability of RETAIN as measured by participant feedback about the intervention; 2) test the impact of RETAIN on knowledge about MAT, as measured by the MAT Knowledge Assessment; 3) assess MAT retention rates in patients completing the RETAIN intervention; 4) test the impact of RETAIN on knowledge about HCV/ HIV; 5) test the impact of RETAIN on interest in being tested for HCV/HIV.
The acceptability of RETAIN will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about MAT and HCV/HIV) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The 3- and 6-month retention rates for RETAIN participants will be compared, using Fisher's exact tests, to the overall treatment retention rates at 3- and 6- months for the UC Health MAT clinics as determined by the retrospective chart review.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45229
- University of Cincinnati Addiction Sciences Division
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 18 years of age
Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;
Exclusion Criteria:
- Does not sign the "short form" consent form
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: RETAIN
Participants who meet criteria will receive the RETAIN self-administered, e-health application intervention.
|
RETAIN is a self-administered, e-health application and includes short videos in which patients who are successfully engaged in MAT discuss what they wish they had known about MAT and its benefits when they started treatment.
The intervention is designed to maximize "scalability" - the administration would entail handing an electronic device (e.g., tablet, laptop, etc.) to an individual who would then self-administer the intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
treatment retention status after 3 months
기간: 3 months
|
To compare with retention rates for the overall MAT clinics and use in sample size calculations for potential follow-on trial
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
treatment retention status after 6 months
기간: 6 months
|
To compare with retention rates for the overall MAT clinics and use in sample size
|
6 months
|
|
MAT Knowledge Assessment
기간: Pre and Post Tests in E-Health App Day 1
|
To test the impact of RETAIN on knowledge about MAT
|
Pre and Post Tests in E-Health App Day 1
|
|
The Injection-Related Infection and Treatment Survey (I-RITS)
기간: Pre and Post Tests in E-Health App Day 1
|
To test the impact of RETAIN on knowledge about HCV and HIV
|
Pre and Post Tests in E-Health App Day 1
|
|
Feedback on the RETAIN e-health application
기간: Day 1
|
feedback includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it.
|
Day 1
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2017-1074-1
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. .
오피오이드 관련 장애에 대한 임상 시험
-
Tianjin Medical University Eye Hospital아직 모집하지 않음진행성 근시 | 소아 근시 | Orthokeratology-related Myopia Progression
-
Jordi Zaragoza아직 모집하지 않음
self-administered, e-health application에 대한 임상 시험
-
St. George's Hospital, London아직 모집하지 않음
-
Centre Hospitalier Universitaire Dijon종료됨
-
Institut National de la Santé Et de la Recherche...National Agency of Public Health; Institut de Recherche en Santé Publique, France; Centre... 그리고 다른 협력자들완전한
-
The Hong Kong Polytechnic UniversityTung Wah College; Hospital Authority, Hong Kong모병
-
Abramson Cancer Center at Penn MedicineFox Chase Cancer Center완전한
-
Tung Wah CollegeThe Hong Kong Polytechnic University; University of Southampton아직 모집하지 않음인지적 허약함
-
Institut Català d'OncologiaInstitut d'Investigació Biomèdica de Bellvitge; Asociación Española contra el Cáncer모병