[미국 FDA의 승인 또는 허가를 받지 않은 장치의 임상시험]
[미국 FDA의 승인 또는 허가를 받지 않은 기기의 임상시험]
연구 개요
상세 설명
Participation in the study will last 12 months. Participants will be asked to complete assessments at 33 timepoints over the 12-month trial. This will include 1 screening assessment, 24 weekly assessments, 6 monthly assessments, and 2 follow-up assessments. All study assessments will be completed remotely.
Staff at each site will identify potential participants being treated with buprenorphine for opioid use disorder at their respective site. Providers will introduce the study and if interested, the participant will complete a screening assessment conducted by trained study staff to determine eligibility for the study.
Participants who are eligible will be enrolled into the study and given access to the KIOS app.
The active phase will include the first 6 months during which time participants will use the app, complete monthly assessments, and complete a weekly craving assessment. The second 6 months in the study will include two follow-up assessments at 9 months and 12 months post study start. At the end of the 12 months, app access will be removed. The follow up assessments will include the monthly assessments that were completed during the active phase, as well as the craving assessment. All assessments will be sent to the participants' email address for them to complete on any device with internet access. At the conclusion of 12 months of study participation, focus groups will be conducted with 25 of the participants to gather information about their perspectives on the app and its usability and features.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Elise Marino, PhD
- 전화번호: (210) 567-5399
- 이메일: marinoe@uthscsa.edu
연구 연락처 백업
- 이름: McKenna Garcia
- 전화번호: (210) 450-7371
- 이메일: garciam98@uthscsa.edu
연구 장소
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Texas
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San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center - Department of Psychiatry
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male or female outpatients 18 years of age or older
- DSM-5 criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Initiated buprenorphine treatment in the past 6 months
Exclusion Criteria:
- Unwilling or unable to comply with study requirements
- A psychiatric or medical condition interfering with ability to use the app
- Incarceration
- Suicide risk as determined by the treating medical clinician at the site
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment as usual and KIOS app
Participants will be set up onto their preferred device(s) with assistance from a research assistant.
KIOS will be accessible on all mobile devices as well as tablets.
Treatment as usual (TAU) will be administered to all participants.
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A digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition.
KIOS offers individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Retention in treatment
기간: Baseline to 1 year
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The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.
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Baseline to 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Statistical Manual Version 5 (DSM-5)
기간: Baseline to 12 months
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DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress
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Baseline to 12 months
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Opioid Craving Scale
기간: Baseline to 12 months
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A brief 3-item measure used to measure opioid craving.
The scale consists of 3 items rated on a visual analog scale from 0-10.
Items are as follows: 1) How much do you currently crave opiates?; 2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates?; and 3) Please imagine yourself in the environment in which you previously used opiates.
If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today.
The total scores range from 3-30 with a higher score indicating more opioid craving.
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Baseline to 12 months
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Patient Health Questionnaire-9 (PHQ-9)
기간: Baseline to 12 months
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A self-administered 9-item depression module that scores each of the 9 DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition).
Items are score 0 to 3, providing a 0 to 27 severity score.
Scores of 5, 10, 15, and 20 represent cutoff points for mild, moderate, moderately severe, and severe depression, respectively.
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Baseline to 12 months
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Generalized Anxiety Disorder-7 (GAD-7)
기간: Baseline to 12 months
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The Generalized Anxiety Disorder-7 (GAD-7)13 measures anxiety with 7 items scored from 0 to 3, providing a 0 to 21 severity score.
Scores of 5, 10, and 15 represent cutoff points for mild, moderate, and severe anxiety, espectively.
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Baseline to 12 months
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Treatment Progress and Recovery (TEA)
기간: 6 to 12 months
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The TEA gauges progress in treatment and recovery within four domains established by prior research: substance use, health (physical or emotional), lifestyle (housing/living situation, family, employment, relationships), and community (obeying laws, responsible member of society).
For each area, the patient is asked to think about how much better things have become on a 10-point scale (1 = not better at all and 10 = very much better).
Scores range between 0-40, with a higher score indicating greater progress in treatment and recovery
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6 to 12 months
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System Usability Scale (SUS)
기간: 6 months
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The System Usability Scale (SUS)15 is a 10-item measure for assessing a system's usability on a 5-point Likert scale from strongly agree to strongly disagree.
Scores are converted to a 100-point scale.
A score above a 68 would be considered above average usability.
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6 months
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KIOS User Satisfaction Survey
기간: 6 months
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Participants complete a survey specific to KIOS regarding: (1) the content, appropriateness, and relevance of the advice; (2) enhancement of self-management skills; (3) selfawareness; and (4) overall satisfaction with health.
Survey items will be answered with level of agreement with a given statement recorded on a Likert-type 0 (Disagree) - 7 (Agree) scale.
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Elise Marino, PhD, The University of Texas Health Science Center at San Antonio
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00002308
- 4R44DA059017-02 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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