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

San Diego State University2 个研究点分布在 1 个国家目标入组 15 人开始时间: 2025年3月1日最近更新: 2025年3月10日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: San Diego State University
入组人数: 15
试验地点: 2
主要终点: Wisepill MEMS Sensor data collection

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 21 Years 至 70 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•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.

排除标准

未提供

结局指标

主要结局

Wisepill MEMS Sensor data collection

时间窗: 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

时间窗: 6 months after enrollment into study

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

Intervention component - Instructions