跳至主要内容
临床试验/NCT03940534
NCT03940534已完成不适用

Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients

Intent Solutions, Inc.4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
4
主要终点
Missed Doses

研究概览

简要总结

A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. This study aims to assess medication adherence relating to missed doses or improperly timed doses with and without the aid of a mobile device as a primary endpoint. Secondary endpoints will be patient, nursing, and provider satisfaction.

详细描述

This study is a randomized crossover study in which patients will be randomized to start with or without a mobile device assisting the patient or caregiver in using the device. The investigators aim to enroll 20 patients across 3 sites. Each patient is expected to participate in the study for 12 weeks. After the first 2 weeks of participation, the patient will either begin using the mobile device to assist or will stop using the mobile device for the next 2 weeks. after the initial 4 weeks, the patient will choose to continue with or without using the mobile device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

盲法说明

No masking is to be used in this study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any patient taking morphine ER or Oxycontin on one of three hospice home teams

排除标准

  • pregnancy
  • inability to demonstrate competent use of the device
  • age less than 18

研究组 & 干预措施

Start without Mobile Device

Active Comparator

干预措施: TAD (Device)

Start with Mobile Device

Active Comparator

干预措施: TAD (Device)

结局指标

主要结局

Missed Doses

时间窗: through study completion, up to 1 year

The number of missed doses that occurred during the study.

Difference from Scheduled Dosing Time

时间窗: through study completion, up to 1 year

The time difference between when the patient took the dose and the scheduled time of administration.

次要结局

  • Physician Satisfaction: scale of 1 to 5(through study completion, up to 1 year)
  • Patient Satisfaction: scale of 1 to 5(through study completion, up to 1 year)
  • Nurse Satisfaction: scale of 1 to 5(through study completion, up to 1 year)

研究者

发起方
Intent Solutions, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验