Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication

Part of paid clinical trials in San Diego, California.

Sponsor
San Diego State University
Study ID
NCT06865755
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)
  • Breast Cancer Survivor

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • integrated medication monitoring (MM) system — DEVICE
    We have created a new integrated medication monitoring (MM) system consisting of baseline, 3-month, and 6-month surveys, smartphone-based ecological momentary assessment via an application installed on a smartphone (Digital Trails based on the UVA Sensus app), a wireless medication event monitoring system device (MEMS; Wisepill), and a wearable sensor (Fitbit), and data collected passively from smartphone sensors using the Digital Trails app. These sources of information will be used to understand predictors of medication taking behaviors and, after two months of monitoring, to deploy appropriate interventions which will be delivered via the Digital Trails app platform.

Study Details

The goal of this study is to learn about the impact of an integrated medication monitoring system in breast cancer survivors aged 21-70 who are prescribed endocrine therapy. The main question it aims to address is: Does the integrated medication monitoring system improve medication adherence among breast cancer survivors when used over a six-month period? Fifteen English-speaking breast cancer survivors who meet the inclusion criteria will use a combination of smartphone-based ecological momentary assessments, a medication event monitoring system (Wisepill), and a wearable sensor (Fitbit). After 2 months, participants will be provided personalized content to facilitate medication adherence through an app (Digital Trails) and through WisePill. Participants will complete online surveys at baseline, 3 months, and 6 months to assess their experiences and adherence.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: integrated medication monitoring system
    The single-arm intervention design of this study focuses on delivering a comprehensive integrated medication monitoring system to a cohort of breast cancer survivors. The system will analyze data collected from EMAs, MEMS, and Fitbit sensors to identify participants at risk of nonadherence. Based on this risk assessment, personalized interventions will be delivered through the Digital Trails app, which may include reminders for medication intake, among others.

Primary Outcome Measure

Wisepill MEMS Sensor data collection [ Time Frame: From enrollment to the end of study at 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Diego State UniversitySan DiegoCalifornia92120
Gabriel Estrella
[email protected]
619-594-3120

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By research site
San Diego State University· San Diego, CA

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