跳至主要内容
临床试验/NCT03862105
NCT03862105已完成不适用

Pilot Testing for Post-Cystectomy mHealth Tool to Improve Perioperative Care

UNC Lineberger Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Feasibility of the tool (Twistle): percentage of patients using the tool at least once weekly

研究概览

简要总结

This is a pilot study that involves human subjects undergoing cystectomy surgery for bladder cancer, testing the utilization of a mobile health app that promotes postoperative patient engagement, along with provider monitoring and care. The aim of this pilot study is to assess feasibility and acceptability of an Internet-based mobile health tool following cystectomy discharge. Objectives will be met by assessing weekly adherence, determining acceptability of mobile health questions post-surgery by patients and providers, and by obtaining participant feedback regarding the tool. Complications, re-admissions, and resource utilization will also be monitored throughout the study. The hypothesis is that an mobile health intervention that tracks PROs, provides educational content, and allows real-time feedback via internet-enabled devices has the potential to improve the quality of care delivery and overall patient experience following surgery by decreasing resource utilization and improving symptom control and communication.

详细描述

Radical cystectomy will be used as a model to examine the utilization of an electronic, internet-based mobile health intervention that can prospectively collect PRO data while providing timely feedback to patients and clinicians. This mobile health intervention will utilize a well-established platform (Twistle) that can be accessed through multiple technologies, including laptops, smartphones, and other computer-based systems. The objective is to evaluate the feasibility of pre-specified Patient Reported Outcomes and educational content in an existing mobile health communications platform which tracks patient symptoms and provides real-time feedback to patients and providers following cystectomy discharge. Patient Reported Outcome questions and responses will be inputted using validated questions with branching logic to drive feedback based upon responses. The intent of this study is to evaluate feasibility and acceptability of this mobile health tool following cystectomy discharge. Usual care will continue in coordination with this 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
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients with invasive bladder cancer scheduled for radical cystectomy at UNC within the next 30 days
  • English-speaking
  • Ability to access the Internet (either themselves or with assistance from their caregiver)
  • Ability to read
  • Ability to provide informed consent.

排除标准

  • Inability to read
  • Inability to provide informed consent
  • Severe psychiatric illness
  • Cystectomy surgery without cancer diagnosis
  • Non-English speaking

结局指标

主要结局

Feasibility of the tool (Twistle): percentage of patients using the tool at least once weekly

时间窗: 90 days postoperative

percentage of patients using the tool at least once weekly

次要结局

  • Acceptability of tool (Twistle): Percentage of patients being satisfied or very satisfied with the mobile health tool(90 days postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验