Mobile Platform for Optimizing Wellness and Engagement in Recovery

Обзор

This pilot study addresses the urgent public health crisis of co-occurring opioid and alcohol use disorders (OUD-AUD), leading causes of mortality in the United States, by testing a scalable digital contingency management (CM) treatment among Medicaid beneficiaries. The study aims to evaluate the feasibility and acceptability of digital CM for OUD-AUD recovery, while also planning for broader implementation.

Вмешательства

• Поведенческое Digital Contingency Management Intervention Arm
  Participants will use a version of the app for 6-months. Participants in this group may earn rewards for completing recovery-related activities and for abstinence from drugs and alcohol. During the 6 months this will include: random saliva drug tests, breathalyzer tests, and video selfies, completing surveys and questionnaires through the app, and receiving rewards on a debit card for abstinent tests, surveys, and activities. Additionally, participants will complete follow-up at approximately 9
• Поведенческое Digital Wellness Arm
  Participants will use a version of the app for 6-months focussed on wellness. During the 6 months this will include: random requests to do saliva drug tests, breathalyzer tests, and video selfies, complete surveys and questionnaires through the app, and receive rewards on a debit card for completing tests, surveys, and activities. Participants in this group may also earn rewards for completing study activities like tests and surveys. Additionally, participants will complete follow-up at approxim

Первичные конечные точки

• Feasibility based on recruitment [Срок оценки: Recruitment period 12 months]
• Feasibility based on adherence [Срок оценки: 6 months (during the Dynamicare program)]
• Feasibility based on Retention [Срок оценки: 6 months]
• Acceptability of the intervention [Срок оценки: 3-month after starting program]

Критерии участия

Критерии включения

• Participants must be enrolled in the Michigan Medicaid program
• Opioid agonist treatment (OAT): Participants must have initiated OAT with buprenorphine or methadone
• Participants must have an OAT prescription and Alcohol use disorder (AUD) based on self-report measure during screening
• Participants must have regular access to a working smartphone and internet connection.
• Participants must have a reliable mailing address to receive study supplies (e.g., salivary drug tests).

Критерии исключения

• Primary Medicare Coverage: Individuals that are dual-eligible for Medicaid and Medicare and aged 65 or older, due to limited availability of Medicaid claims data for this group
• Individuals that cannot voluntarily provide informed consent themselves for any reason, including legal incompetency
• Individuals with substantial cognitive impairment that would interfere with study participation
• Individuals unable to read or understand English
• Individuals experiencing active suicidality or psychosis.
• Individuals with a planned admission to residential treatment or incarceration during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07178990 · HUM00266546 · 1R34AA031870-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗