Pilot-scale, Randomized Study Comparing Self-monitoring of Weight and Blood Pressure Via an Electronic Health Journal (patientMpower Platform) With Usual Care in Haemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Patient Engagement With patientMpower App to Record Body Weight
研究概览
简要总结
Pilot-scale study to assess the effect of self-monitoring using the patientMpower electronic health journal (pMp app) [+digital weighing scales & BP monitor] on outcomes in ambulatory haemodialysis patients. Design: prospective, open-label, random order, sham-controlled, two-period crossover comparison of the pMp app [+digital weighing scales & BP monitor] compared with a sham application (without weighing scales or BP monitor). Duration: 10 weeks (usual care run-in for 2 weeks followed by 2 x 4 observation periods).
Primary objective is to determine the frequency of use of the pMp app [+digital weighing scales & BP monitor] in patients randomized to that observation method. Additional objectives are to determine the effect of pMp app [+digital weighing scales & BP monitor] on proportion of haemodialysis sessions in which ultrafiltration rate is ≤ 10 mL/kg/h and in which interdialytic weight gain (IDWG) is ≤ 4% and effect of pMp on pre-dialysis weight and BP, medication adherence, compliance with daily recording (of fluid intake, weight, BP) and requirement for additional unscheduled dialysis.
An additional objective is to assess the acceptability and utility of the pMp app in helping hemodialysis patients and their healthcare professional caregivers manage their condition (assessed from both patient and healthcare professional perspective).
详细描述
Pilot-scale, prospective, open-label, randomized, two-period, cross-over intervention study.
Each patient will be randomized to one of the two possible observation sequences:
Sequence 1: run-in (2 weeks): usual care followed by period 1 (4 weeks): patientMpower application (+digital weighing scales & BP monitor) followed by period 2 (4 weeks): sham application
OR
Sequence 2: run-in (2 weeks): followed by period 1 (4 weeks) sham application followed by period 2 (4 weeks): patientMpower application (+digital weighing scales & BP monitor)
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
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
- •Requires maintenance hemodialysis in an ambulatory care setting.
- •Aged at least 18 years.
- •Has daily unrestricted access to a suitable smart phone or tablet device at home.
- •Has an e-mail address.
- •Has home broadband and/or mobile data as part of their mobile phone service.
- •Demonstrates understanding of correct use of the patientMpower application, digital weighing scales, BP monitor and other study equipment.
- •Capable and willing to perform measurements (e.g. weight, BP) at home and record information on the patientMpower application on a daily basis.
- •Willing to give written informed consent.
排除标准
- •Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters on an electronic health journal
结局指标
主要结局
Patient Engagement With patientMpower App to Record Body Weight
时间窗: 28 days
Actual number of days body weight reported by patient on patientMpower app
次要结局
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h)(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight)(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%)(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight(28 days)
- Patient Engagement With patientMpower App to Record Medication Adherence(28 days)
- Patient Engagement With patientMpower App to Record Blood Pressure.(28 days)
- Patient Engagement With patientMpower App to Record Symptoms(28 days)
- Patient Engagement With patientMpower App to Record Fluid Intake(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis.(28 days)
- Patient Opinion on Utility and Acceptability of patientMpower Application(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility(28 days)
- Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter(28 days)