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临床试验/NCT04669249
NCT04669249已完成不适用

PROCare: Cloud Process Support for Opioid Recovery Participation and Learning

Medical Decision Logic, Inc.2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Percentage of Participants Completing Outcomes Monitoring Surveys

研究概览

简要总结

A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • access to internet-enabled smartphone device
  • primary DSM-5 opioid use disorder diagnosis
  • receiving medication treatment for opioid use disorder with buprenorphine
  • English language proficient

排除标准

  • active suicidal ideation or psychotic symptoms

结局指标

主要结局

Percentage of Participants Completing Outcomes Monitoring Surveys

时间窗: 4-week

Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.

Percentage of Participants Fully-Adherent to Care Plan

时间窗: 4-week

Assessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.

Percentage of Participants Fully-Adherent to Buprenorphine

时间窗: 4-week

Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.

次要结局

  • Percentage of Participants Using Opioids(4-week)
  • Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up(4-week)
  • Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up(4-week)
  • Percentage of Participants Using Other Substances (Non-opioids)(4-week)
  • Motivation as Assessed by Readiness Ruler(4-week)
  • Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up(4-week)
  • Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up(4-week)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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