What side effects are associated with this type of intervention?

Common treatments in telemedicine and digital health interventions, such as mobile health smartphone applications, generally have minimal physical side effects. However, users may experience issues related to technology use, such as eye strain, headaches, or sleep disturbances due to prolonged screen time. Additionally, there can be psychological effects, including anxiety or frustration from technical difficulties or lack of immediate human support. Ensuring proper user training and support can help mitigate these issues.

What prior FDA approvals exist?

The FDA has approved various digital health interventions aimed at managing chronic conditions and supporting behavioral health, including mobile health applications and telemedicine platforms. These approvals often focus on remote monitoring, patient engagement, and adherence to treatment plans. For example, digital health tools for diabetes management, mental health support, and smoking cessation have received FDA clearance. While specific approvals for mobile health applications with varying levels of human support, as studied in the Mobile Health Smartphone Application trial, are not detailed, the trend indicates a growing acceptance of digital health solutions that enhance patient care through remote and personalized interventions.

What other types of research exist?

Promising novel alternatives to Mobile Health Smartphone Applications for telemedicine patients in 2024 include: 1) Virtual Reality (VR) for pain management and mental health therapy, providing immersive environments for therapeutic interventions. 2) Artificial Intelligence (AI)-driven chatbots and virtual health assistants for personalized health coaching and mental health support. 3) Remote patient monitoring devices integrated with AI analytics for chronic disease management, offering real-time data and predictive insights. 4) Telehealth platforms with integrated biometric sensors for comprehensive remote physical exams. 5) Blockchain technology for secure and transparent health data management, enhancing patient privacy and data integrity.

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Mobile Health App for Alcoholism

N/A

Waitlist Available

Led By Andrew Quanbeck, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a smartphone app to help people with alcohol use disorder reduce their drinking. The app offers tools, support from friends or healthcare professionals, and personalized advice to help users manage their drinking habits.

Who is the study for?

This trial is for adults over 21 within the UW Health system area who want to cut down on drinking, meet criteria for risky alcohol use, own a smartphone, and are willing to use the A-CHESS app. It's not for those with severe alcohol disorders, current psychosis, immediate hospitalization needs or terminal illness.

What is being tested?

The study tests three ways of using the A-CHESS mobile app in helping people with alcohol use disorder: self-monitored use; peer-supported monitoring; and clinical integration with a health coach. Participants will be divided into these groups randomly.

What are the potential side effects?

Since this trial involves a mobile health application rather than medication, traditional side effects are not expected. However, users may experience stress or anxiety related to self-monitoring or interacting with peers/health coaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of risky drinking days

Secondary study objectives

Cost of implementation of each intervention arm in US dollars

Number of days health coach/other clinician used the A-CHESS dashboard

Number of healthcare services used in the past 6 months

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Peer supportedExperimental Treatment1 Intervention

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.

Group II: Clinically integratedExperimental Treatment1 Intervention

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.

Group III: Self monitoredActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

A-CHESS peer-supported

2020

N/A

~560

A-CHESS clinically-integrated

2020

N/A

~560

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Telemedicine treatments, particularly those involving mobile health applications, often utilize digital health interventions to provide real-time monitoring, reminders, and educational content to patients. These applications can be enhanced with varying levels of human support, such as peer mentors or health coaches, to improve adherence and outcomes. The mechanisms of action include continuous patient engagement, personalized feedback, and behavioral reinforcement, which are crucial for maintaining treatment efficacy and improving health outcomes. For telemedicine patients, these mechanisms ensure consistent support and guidance, which can be particularly beneficial in managing chronic conditions and promoting long-term health behavior changes.