Assessment of Telehome Monitoring in Patients on Peritoneal Dialysis (CONNECT Trial): A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 467
- 试验地点
- 22
- 主要终点
- Composite clinical outcome
研究概览
简要总结
Compared to hemodialysis, patients on peritoneal dialysis live longer and healthier, have a higher quality of life and cost approximately $40,000 less to the healthcare system per patient per year. However, only 18% of dialysis patients in Canada currently use peritoneal dialysis because patients often feel isolated from the healthcare team and lack the confidence to manage treatments by themselves. This study will assess a telehome monitoring system (eQ Connect™), allowing for up-to-date data transmission and digital interaction between the patients at home and their healthcare team. From the patients' perspective, this technology is an easier way to communicate with their healthcare providers, track their treatment and supplies, and receive training and support. From the providers' perspective, eQ Connect™ delivers up-to-date patient data and provides an efficient way to keep track of the patients' progress. This intervention has the potential to improve the patients' clinical outcomes, quality of life, reduce the costs of dialysis to the healthcare system and ultimately empower patients to start and stay on peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Able to provide informed consent
- •Patient or primary care giver able to read and speak English
- •Over 18 years of age
- •Patient on PD (APD/CAPD) for at least 3 months
- •Patient or primary care giver cognitively and physically capable and willing to interact with a tablet computer and perform self-measurements (e.g. taking weight)
排除标准
- •Scheduled kidney transplant within 1 year (identified, processed and medically worked out their donor)
- •Life expectancy <1 year (estimated by physician)
- •In long-term care facility
- •Deemed unable to comply with the telehome monitoring support system (e.g. due to vision problems, literacy, lack of manual dexterity to accurately interact with the tablet, or decreased cognitive function such as memory loss) by physician
- •Participating in another interventional trial that could influence the intervention or outcome of this trial
- •Was in another interventional trial that could influence the intervention or outcome of this trial, ≤4 weeks prior to recruitment
- •Patients on hybrid dialysis (those on both peritoneal dialysis and hemodialysis)
结局指标
主要结局
Composite clinical outcome
时间窗: 1 year (plus 12 weeks for complete follow-up of technique failure)
The primary outcome is a composite of technique failure (switching to hemodialysis for ≥12 weeks), infections (peritonitis, exit-site, tunnel) and hospital encounters (ER visits, hospitalizations).
次要结局
- Number of clinic visits(1 year)
- Nursing Costs(1 year)
- Dialysis Supplies Costs(1 year)
- Health-related Quality of Life(1 year)
- Time spent communicating(1 year)
- Healthcare Utilization Costs(1 year)
- Number of missed appointments(1 year)
- Nurse Overtime hours(1 year)
- Hospitalization Days(1 year)