跳至主要内容
临床试验/NCT02689687
NCT02689687已完成不适用

Automated Hovering to Improve Medication Adherence and Weight Management Among Congestive Heart Failure Patients: A Pilot Study

University of Pennsylvania0 个研究点目标入组 20 人开始时间: 2016年2月1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
入组人数
20
主要终点
Number of patients successfully setup on the remote monitoring devices

研究概览

简要总结

This study offers remote monitoring devices for weight and medication adherence, combined with behavioral economic approaches, to patients with congestive heart failure (CHF). This pilot study aims to evaluate the feasibility of enrollment processes and intervention roll-out to inform a randomized controlled trial, to estimate the readmission rate of participants, and to assess if and how managing clinicians respond to weight gain alerts entered into a participant's electronic medical record.

详细描述

The specific aims of this study are: (1) To leverage access to the University of Pennsylvania Health System (UPHS) CHF clinic, PennChart (electronic medical record system) resources for identifying eligible patients, and the Way to Health (WTH) platform to launch a pilot study that will inform a randomized controlled trial; (2) to evaluate the feasibility of the enrollment processes and intervention roll-out to inform a randomized controlled trial; (3) to estimate the readmission rate of participants; and, (4) to assess if and how managing physicians respond to weight gain alerts entered into participant charts in PennChart. In this pilot study, no randomization will occur and all participants will receive the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Discharged to home within the past 30 days from a UPHS hospital with a principal diagnosis of CHF
  • •Aged 18 to 80 years old
  • •Will receive follow-up in a UPHS outpatient clinic by a cardiologist or primary care physician

排除标准

  • •Less than 18 years old or older than 80 years old
  • •Will not or cannot provide informed consent
  • •Have a markedly shortened life expectancy (listed for heart transplant, have ventricular assist device, are inotrope dependent, have metastatic cancer, or have dementia)
  • •Have end-stage renal disease
  • •Have a glomerular filtration rate <25 ml/min
  • •On dialysis
  • •Heart failure is managed with a CardioMEMS monitor
  • •Receiving another remote monitoring/telemedicine intervention
  • •Receiving follow-up care outside of UPHS

研究组 & 干预措施

Intervention

Experimental

All participants will be (1) given an electronic pill bottle for their diuretic and a Bluetooth scale; (2) asked to provide the coordinator with name and contact information of a family member or friend to serve as a support partner; (3) will be assigned a 2-digit number to be used as part of the lottery-based engagement incentives in which eligibility to win will be conditional on medication adherence and registering a weight measurement; and, (4) will determine their preferences for Way to Health platform communication methods during the study.

干预措施: Support partner (Behavioral)

Intervention

Experimental

All participants will be (1) given an electronic pill bottle for their diuretic and a Bluetooth scale; (2) asked to provide the coordinator with name and contact information of a family member or friend to serve as a support partner; (3) will be assigned a 2-digit number to be used as part of the lottery-based engagement incentives in which eligibility to win will be conditional on medication adherence and registering a weight measurement; and, (4) will determine their preferences for Way to Health platform communication methods during the study.

干预措施: Engagement incentives (Behavioral)

Intervention

Experimental

All participants will be (1) given an electronic pill bottle for their diuretic and a Bluetooth scale; (2) asked to provide the coordinator with name and contact information of a family member or friend to serve as a support partner; (3) will be assigned a 2-digit number to be used as part of the lottery-based engagement incentives in which eligibility to win will be conditional on medication adherence and registering a weight measurement; and, (4) will determine their preferences for Way to Health platform communication methods during the study.

干预措施: Electronic pill bottle (Behavioral)

Intervention

Experimental

All participants will be (1) given an electronic pill bottle for their diuretic and a Bluetooth scale; (2) asked to provide the coordinator with name and contact information of a family member or friend to serve as a support partner; (3) will be assigned a 2-digit number to be used as part of the lottery-based engagement incentives in which eligibility to win will be conditional on medication adherence and registering a weight measurement; and, (4) will determine their preferences for Way to Health platform communication methods during the study.

干预措施: Bluetooth scale (Behavioral)

结局指标

主要结局

Number of patients successfully setup on the remote monitoring devices

时间窗: 30 days

次要结局

  • Proportion of weight gain alerts that are opened(30 days)
  • All-cause readmission rate(30 days)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Automated Hovering for Congestive Heart Failure... | 临床试验