Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Amount of fluid consumed
研究概览
简要总结
Methods are needed to help decrease interdialytic weight gains in hemodialysis patients. One potential method for accomplishing this goal is to develop an app for smartphones that allow patients to track their fluid intake throughout the course of the day. This protocol is designed to test the safety and efficacy of this app, followed by use of the app in patients with large fluid weight gains between HD sessions. In the Vanguard phase, patients without large interdialytic fluid gains (less than 4%) will use the app to to determine the association between the interdialytic weight gain and the fluid consumed as recorded by use of the app for each interdialytic period. The app will be modified, if needed, prior to initiation of the full scale trial.
详细描述
For the Vanguard phase of the trial, a survey will be used to assess the usability of the app as well as to collect recommendations for changes to the app itself (appendix one). For this Vanguard phase study, the survey for participants will be designed to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of preselected volumes for fluid containers, reasons for not using the app more frequently, the usefulness of the app notifications, ease of sending data to the study coordinator for review). The survey for the study coordinator will be designed to assess the ease of reviewing data from participants and the perceived difficulty of patient use of the app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study.
- •Adult chronic hemodialysis patients who are at least 18 years of age
- •Average interdialytic fluid gains of less than 4% of body weight for both weekdays and weekends for a 30 day period
- •Access to a smartphone for use of the app and comfort with using apps on a regular basis
- •Access to a smartphone running under either iOS or Android operating systems
- •Sufficient knowledge and understanding of the English language to use the application available only in English (US) language
- •Mental capacity to use and understand the fluid management app
- •Willingness to share intake data collected with the research team
排除标准
- •Scheduled for a living related renal transplant in the next four months
- •Class III or IV heart failure
- •Need for chronic oxygen therapy due to pulmonary disease
- •Hospitalization within 30 days of entry into the study
- •Current participation in a randomized clinical trial or in the exclusion period of another clinical trial
结局指标
主要结局
Amount of fluid consumed
时间窗: 1 month
The fluid consumed as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.
Amount of interdialytic weight gain
时间窗: 1 month
The amount of weight gain as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix.
次要结局
- Number of patients who experienced a 50% increase in fluid intake during app use(1 month)
- Ratio of weight of liquid intake(1 month)
- Number of days that the app was used(1 month)
- Number of days that the app was used by day of the week(1 month)
- Number of days that the app was used by dialysis or non-dialysis days(1 month)