Integrating mHealth for Alcohol Use Disorders Into Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Percentage of Heavy Drinking Days, PHDD
研究概览
简要总结
This study evaluates the impact on risky drinking days and quality of life for patients with alcohol use disorder among patients who use a mobile health smart phone application. A third of the participants will receive access to the smart phone app without any monitoring; a third of the participants will receive access to the smart phone app monitored by and connected with a peer mentor; a third will receive access to the smart phone app monitored by and connected with a health coach who works within a healthcare system.
详细描述
Patients in the trial will be given versions of an evidence-based mobile-health (mHealth) system (re-design based on A-CHESS) that is delivered using different implementation strategies according to study group. A-CHESS has more than 18 services designed to improve social relatedness, coping competence, and intrinsic motivation. The following describes key A-CHESS services that will be tested in the current study:
- Welcome message - patients write why they are choosing to reduce their drinking.
- Coping with Cravings - the system automatically notifies nearby pre-approved friends, family, and peers, who can respond to a request for support. The patient can also be linked to positive activities, such as suggested games to download and play and audio/video-based relaxation recordings.
- Monitoring functionality- self-assessment measures, record of A-CHESS use, and prediction of the patient's likelihood of having a heavy drinking episode in the next week. A-CHESS sends patients with worrisome responses suggestions of coping skills, online peer support, healthy events, etc. With patient permission, a prediction of high-risk can be shared with others in a position to provide support.
- Triage and feedback functionality is designed to derail a setback in goal attainment, giving the patient 'just in time,' tailored support by linking patients to relevant A-CHESS resources or individuals (depending on group assignment).
- The Specialist Report, harvests clinically relevant data from A-CHESS and presents it to a peer mentor (in the peer-supported group) or a health coach (in the clinically integrated group), at which point they may intervene with patients (e.g., through texting in A-CHESS).
- Facilitated discussion groups (in the clinically integrated group.) Discussions are monitored daily by an A-CHESS coach.
- Library - information about healthy lifestyle choices, calendar of healthy events in the area, etc.
- Drink tracker and report feature - patients to self-monitor their drinking and each week see a summary of how they did the past week.
- Profiles about why patients want to reduce their drinking.
All patients enrolled in the study will participate in a 3-month intervention period followed by a 9-month follow-up period, for a total of 12 months. All patient will undergo a 72-hour run-in period. After 72 hours, patients who remain in the study will be randomized to one of the following groups and receive the appropriate access to features. One group will operate independently; one group will have help from a peer-mentor; one group will be connected to a healthcare system by a health coach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are 21+ years old,
- •interested in learning about ways to reduce drinking,
- •willing to download and use A-CHESS,
- •lives in within the geographical boundaries of the UW Health system
- •be able to understand and sign an electronic consent form in English,
- •own an Apple or android smart phone,
- •meets the criteria for at risk drinking on the AUDIT screening,
- •responds yes to at least one question on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5 survey, and
- •indicates in the past week they have had at least 7 drinks and 3 on a single day (women), or had at least 14 drinks and 4 on a single day (men).
排除标准
- •has a severe alcohol use disorder (yes to 6+ items on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5)
- •have a current psychotic disorder
- •have an acute medical problem requiring immediate hospitalization
- •have a known terminal illness
研究组 & 干预措施
Self monitored
Patients of this group will continue receiving regular care from their physician with no interference from the two experimental groups. Patient subjects will download the app on their Android or Apple smart phone that will direct them to external information hosted on the internet that may help reduce their drinking (e.g., NIAAA resources). For the first 12 weeks, once a week patients can set a weekly goal related to their alcohol use or other health related behaviors (e.g., "I will only drink on Friday this week."). At the end of the week subjects will be prompted to take a weekly survey, which will include questions such as a variation of the brief alcohol monitor (BAM) and timeline followback. Patients will then receive feedback on the amount of drinks they had compared to their goal. Then the patient will set a new goal for the following week. Patients will complete quarterly surveys on the A-CHESS app to assess study outcomes.
干预措施: A-CHESS self-monitored (Behavioral)
Peer supported
Patients will be asked to take the same surveys and have the access to the same information as the self-monitoring group. Patient subjects in this group will have access to discussion boards where they can talk to one another and have the ability to share and see stories of other patients. The only involvement of someone other than patients themselves in the peer-supported group will be by a sponsor (i.e., a dedicated user from the area with a sustained history of successful alcohol reduction). The sponsor will participate in discussion groups and encourage use of the system. Patient-reported feedback will be presented directly to the patient.
干预措施: A-CHESS peer-supported (Behavioral)
Clinically integrated
Patients in the clinically integrated group will receive the same intervention as the peer-supported group aside from three differences: 1) patients have the option to share selected elements of their app data with the University of Wisconsin (UW) Health health coach, 2) the health coach will replace the role of the sponsor in the peer-support group, and 3) patients will have the option to attend an initial 60- to 90-minute and two 30-minute follow-up consultations with the health coach in-person, via phone, or via video chat.
干预措施: A-CHESS clinically-integrated (Behavioral)
结局指标
主要结局
Percentage of Heavy Drinking Days, PHDD
时间窗: 12 months
Percentage of self-reported Heavy Drinking Days (HDD: 5 or more standard drinks on any day for men under 65, 4 or more standard drinks for women and men over 65) in the last 7 days
Quality of Life-Physical Health
时间窗: 12 months
The physical health subscale of Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 short form was used to assess the quality of life-physical health (QoL-PH). It consists of 4 questions that assess overall physical health aspect of quality of life. Each question will ask patients to indicate their physical health on a scale of 1 (poor) to 5 (excellent). The raw scores of physical health scores (range: 0 to 20) are converted to T-scores (16.2 to 67.7). Higher scores mean better physical health aspects of quality of life.
Quality of Life-Mental Health
时间窗: 12 months
The mental health subscale of Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 short form was used to assess the quality of life-mental health (QoL-MH). It consists of 4 questions that assess overall mental health aspect of quality of life. Each question will ask patients to indicate their mental health on a scale of 1 (poor) to 5 (excellent). The raw scores of mental health scores (range: 0 to 20) are converted to T-scores (21.2 to 67.6). Higher scores mean better mental health aspects of quality of life.
次要结局
- Number of Hospital Nights in the Past 6 Months(12 months)
- Time of Tula Used(12 months)
- Number of Setback Status Triggered by A-CHESS(12 months)
- Number of Patients Who Are Willing to Share Data(12 months)
- Cost of Implementation of Each Intervention Arm in US Dollars(up to 3 years)
- Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool(12 months)
- Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity(12 months)
- Score of Relatedness as Assessed by the CHESS Bonding Scale(12 months)
- Score of Competence as Assessed by the Perceived Competence Scale (PCS)(12 months)
- Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire(12 months)
- Variables Used for Predictive Setback Status(up to 3 years)
- Number of Response Statuses Addressed(up to 3 years)
- Pages Viewed on A-CHESS(12 Months)
- Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor(12 months)