This Phase I Small Business Innovation Research (SBIR) project will examine the technical merit and real-world feasibility of the Affect smartphone application ("app") as the core component of the Affect digital care program for treatment of methamphetamine use disorder (MUD).
The project includes a clinical trial that will assemble data on the functionality of the app in engaging patients and delivering treatment components and related services, using outputs to guide rapid refinements of the app's functions (e.g., active and passive data collection, patient inference engine, triggers for clinician actions, user interfaces). The project will analyze these and other aspects of the app and program to assess their associations with patient engagement, participation, and retention, providing indication of the overall program's clinical utility. Aim 1. Confirm the technical merit and feasibility of the Affect app and its delivery of the Affect digital care program in real-world practice based on results from the clinical trial. Aim 2. Identify components of the Affect app and the Affect digital care program that correlate with patient engagement, participation, retention, and changes in methamphetamine use. Aim 3. Use results to iteratively refine the Affect app and care program to improve treatment of MUD toward substantiating commercialization. Demonstrating the technical merit, feasibility, and clinical utility of the Affect app and digital care platform could lead to improved clinical care for the 1.6 million people in the nation who need treatment for MUD. Results of this project have high potential to inform additional work to advance commercializability of the Affect program and its app, which would increase access to affordable, effective care for those who never receive treatment among the 2 million in need. If technical merit is demonstrated and the program is shown to be feasible and effective in retaining participants in treatment, the Affect app will be an important element in efficiently achieving optimum patient outcomes at reasonable cost.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Telemedicine based group and individual therapy, drug screens, contingency management, therapeutic app engagement, psychiatric interventions for adjuvant medications.
Affect Therapeutics
New York, New York, United States
Participation retention and completion of treatment
Participant retention and completion of the program will be measured as consistency of participant involvement through the end of the 8-week program, with criteria for completion being data on participation in \>50% of potential therapeutic interactions and activities. A related "time in treatment" measure will also characterize retention (and detail aspects of engagement). At the end-of-program telephone interview, participants will be deemed to be either treatment completers (i.e., retained) or dropouts (not retained if out of program before the end of week 4 (excluding those who drop out in week 1).
Time frame: Up to 8 weeks through the duration of treatment
Patient engagement and program adherence
The nature/degree of participation in this study will be measured as the number of successfully "attended" therapeutic tasks/events/activities per the Affect app relative to not-attended events such as: scheduled/planned digital/virtual interactions for program activities (e.g., counseling, group meetings), completed biological assessments (remote drug biologic tests), and kept appointments with referred service providers (e.g., psychiatrists, physicians). Engagement with the Affect app components will be assessed via app-derived data on activity (i.e., duration, frequency, consistency of involvement with app-directed tasks). We will extract use-specific data on participants' interactions with the app, as well as results of surveys/questionnaires/focus groups to characterize associations of app and program components and procedures and their impacts on patient-level outcomes (e.g., retention in the program and meth use).
Time frame: Up to 8 weeks through the duration of treatment
Effectiveness in reducing meth use
The effectiveness outcome is determined by demonstrated reductions of meth use measured via a composite measure of self-reported meth use (daily Yes/No) plus results of biologic screens to provide indication of effectiveness. The criterion measure of clinically meaningful reduction of meth use will be 4 meth-negative biologic screens of the 8 possible biologic screens during the final 4 weeks of the 8-week program (concurring with self-report of no meth use).
Time frame: Through study completion, an average of 6 months
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