Deploying and Evaluating a Technology Based System to Help People Adhere to Long Term Medications

San Diego State University1 site in 1 country15 target enrollmentStarted: March 1, 2025Last updated: March 10, 2025

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: San Diego State University
Enrollment: 15
Locations: 1
Primary Endpoint: Wisepill MEMS Sensor data collection

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Detailed Description

Purpose/objective:

The investigators have created a new integrated medication monitoring (MM) system for long-term monitoring of medication adherence consisting of baseline, 3-month, and 6-month surveys, smartphone based ecological momentary assessment, smartphone sensors, a medication event monitoring system (MEMS; Wisepill) sensor, and a wrist-worn wearable sensor (Fitbit) that will be used to collect data to understand and model medication-taking behaviors. The objective of the project is to deploy this system to predict nonadherence to endocrine therapy for breast cancer survivors and implement intervention strategies to improve medication adherence. These interventions will be evaluated for preliminary impact on behavior, acceptability, attractiveness, and usefulness.

Overview:

The investigators will conduct a single arm study collecting data in multiple ways and multiple intervals, over six months' time: 1) baseline, 3-month, and 6-month surveys via Qualtrics; 2) smartphone-based ecological momentary assessment (via Digital Trails application) at the following intervals: every 2-3 days, weekly, and monthly; 3) wireless medication event monitoring system devices (MEMS; Wisepill; daily), 4) a wrist-worn wearable sensor (Fitbit; continuous); and 5) smartphone sensors (data collected via Digital Trails application, continuous). Participants will be provided personalized intervention content based on their specific risk via the Digital Trials app. Fifteen breast cancer survivors will be asked to participate in this longitudinal study for six months.

Intervention:

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Supportive Care
Masking: None

Eligibility Criteria

Ages: 21 Years to 70 Years (Adult, Older Adult)
Sex: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

•are English-speaking and reading;
•are between ages 21 and 70 years;
•are diagnosed with stage 0-3 breast cancer in the past 5 years;
•have completed all surgery, radiation, and chemotherapy, except endocrine therapy;
•are prescribed endocrine therapy;
•do not have a physical impairment that would prevent them from using the MM system;
•are able to provide informed consent;
•are willing and able to use the MM system for 6 months;
•have an Iphone or Android phone.

Exclusion Criteria

Not provided

Arms & Interventions

integrated medication monitoring system

Experimental

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.

Intervention: integrated medication monitoring (MM) system (Device)

Outcomes

Primary Outcomes

Wisepill MEMS Sensor data collection

Time Frame: From enrollment to the end of study at 6 months

Participants will be asked to put their endocrine therapy medication in the Wisepill device and will be asked to open the Wisepill when taking their medicine daily for six months

Intervention component - Introduction

Time Frame: 6 months after enrollment into study

Number of respondents who reported receiving and/or using the app introduction

Intervention component - Instructions