Evaluating Patient Safety And Ease Of Use Of A Novel Connection-Assist Device For Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Nasa Task Load Index (N-TLX)
研究概览
简要总结
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study.
详细描述
The growth in the renal replacement therapy population is primaryly in the elderly age group, a population with a high frailty and comorbidity burden. Facilitating PD in this group of patients requires improved PD technology with greater accessibility tailored to patient needs. Following evaluation of specific barriers to the use of PD including feedback from established PD patients, a novel connection-assist device has been developed.
As part of the CE marking authorization, the connection device has been evaluated for safety and ease of use in a study at University Hospitals Birmingham NHS Foundation Trust involving 24 patients and carers.
The evaluated device is designed to assist peritoneal dialysis patients performing their daily dialysis treatment either for APD or for CAPD. The device facilitates the connection and disconnection of the dialysis line to the PD catheter transfer set. The connections are performed inside the device in a protected area, and the patient does not need to touch the transfer set or the dialysis line while they are unprotected. In addition, the breaking of the dialysis line frangible and the clamping of the dialysis line are replaced by pushing a button.
The operating procedure of the device consists of multiple tasks including preparing and loading the transfer set and dialysis line into the device, performing the handling steps related to the PD therapy with the device and finally unloading the used material from the device. Each task comprises several handling steps. During the study, the operating procedure with the device was simulated and the subjects were connected to a dummy catheter, which was attached to an apron.
This study recruited established PD patients and carers involved in the delivery of PD. Carers included healthcare professionals and lay carers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device.
For each subject, one moderator and one observer were involved in the study. The moderator was the interface between the subject and the device both in training and in testing. This person was employed by an external agency to avoid any influence on the subject.
The observer saw the handling with the help of a live feed from a separate room. He evaluated the handling steps in the categories of "safe use" and "use error" according to IEC 62366-1 (2015). For each use error, the observer described the observed situation from his point of view.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fifteen patients and nine carers volunteered in this study, ranging from 23 to 86 years in age and from 0.3 to 24 years in experience in the PD therapy.
排除标准
- 未提供
结局指标
主要结局
Nasa Task Load Index (N-TLX)
时间窗: 3 hours
The operating procedure of the device consists of multiple tasks comprising several handling steps. the subjects were asked about the task load in six different dimensions in the standardized N-TLX. Task load is a hypothetical construct that represents the cost incurred by a human operator to achieve a particular level of performance. The dimensions of the N-TLX are mental, physical and temporal demands as well as performance, effort and frustration in the task. Each dimension is evaluated on a 20-point scale. This scale is then transferred to the task load index, which is a scale between 0 and 100 points. Workload levels below 50 were perceived as acceptable.
Observation of technique
时间窗: 3 hours.
Here the observations of technique errors were discussed with the subjects in order to identify the specific causes. In this interview, the subjects were also asked for their feedback on the general ease of use of the device.
Safety and ease of use of a connection device during a continuous ambulatory peritoneal dialysis
时间窗: 3 hours
Firstly, a training session introduced the operation of the device. The normal steps of a manual connection and breaking of the frangible is replaced by the levers and the buttons in the device. The connections are thereby done in a 'safe' environment which reduces infection risk. A whole cycle of continuous ambulatory peritoneal dialysis is simulated during each training. Secondly, a break of one hour allowed relaxation and recovery. Thirdly, a test was carried out to determine whether the subject could use the device independently with the aid of a quick start guide and the device manual. The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device. Each of the 24 subjects performed 52 handling steps resulting in a total of 1248 evaluated handling steps.
次要结局
未报告次要终点