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临床试验/NCT05916495
NCT05916495已完成不适用

An Evaluation of Remote Care (Questionnaire+Hybrid) in Patients Who Are Post-lung Transplant

University of Manchester1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Number of clinic visits per patient

研究概览

简要总结

Lung transplantation is used to treat patients with lung damage when there is no other treatment option. Patients require close monitoring following their transplant, with hospital check-ups every 3-4 months usually lasting all day. Although check-ups often result in no change to patient management they are essential as patients have better outcomes if complications are detected quickly.

The aim is to explore whether remote monitoring via an app (patientMpower) ± questionnaire (specifically designed to assess post-transplant patients' health), linked to a device to measure lung function, could replace some check-ups for lung transplant patients.

Patients will be randomised to receive either normal care or remote monitoring (i.e. their symptoms will be evaluated using home spirometry combined with a questionnaire). 100 lung transplant recipients will be enrolled with 50 patients being assigned to either group. Health outcomes and costs of care between the two groups will be compared

详细描述

100 lung transplant patients are expected to be recruited. Consent will be taken by the research team. Following admission they will be randomised to the interventional or control arms. The control arm will consist of follow-up according to unit policy, in the majority of cases this will be every 3 months. The only change is that when they come to follow up the patients will be asked to fill in the same interventional questionnaire (designed to assess post-transplant lung health) that the interventional arm are completing. However, they will be seen regardless of what this questionnaire reports.

This will act as validation for the questionnaire. The interventional arm will replace the 3 monthly visits with a questionnaire which the patient will be asked to complete and then this will be returned to the unit. The patient can fill this in via the app, or on paper and return the questionnaire via email or post. The duty clinician will then review the questionnaire and combine this with the home spirometry data which the patient is already completing to see if the patient needs to be seen. In the majority of cases, its expected that the patient will not need to be seen as the clinic visits in lung transplant are mainly monitored and the vast majority of the patients are seen every 3-4 months. Regardless of the outcome, the participant will receive a phone call from the transplant nurse within 48 hours of the appointment to discuss the results of the blood test and confirm that they are okay.

In addition to the questionnaire to assess lung health, all participants will be asked to complete other respiratory/sleep questionnaires such as Saint George's Respiratory (SGRQ), Morningness-eveningness (MEQ-SA) and the Pittsburgh Sleep Quality Index (PSQI). This will investigate whether more complex questionnaires are needed to see if patients require clinical follow-up. Study duration is predicted to be 6 months per participant. During the whole study, volunteers will be asked to wear an activity tracker such as Fitbit. Using the device's application programming interface (API) investigators will be able to remotely access data concerning heart rate, accelerometry and sleep duration, including stages of sleep. This will be accessed as required anticipated to be once per week, followed by phone calls to patients should the data be missing. In addition, their clinical record will also be accessed to obtain clinical data for instance if a sleep study has been performed. Patients will be asked to perform daily home spirometry using a Bluetooth enabled spirometer. It is currently being used in the Manchester lung transplant program. If patients have not submitted a reading for one week then they will be contacted by the study team to offer assistance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Looked after by a clinical care team at Manchester University NHS Foundation Trust
  • •Given consent
  • •Have received a lung transplant

排除标准

  • •Consent not given
  • •Not able to operate the remote monitoring platform

研究组 & 干预措施

Hybrid care arm

Experimental

Remote review of information collected electronically will be combined with in person visits at a hospital

干预措施: Hybrid care arm (Other)

Standard of care arm

Active Comparator

Patients will be seen in person at a hospital clinic.

干预措施: Standard of care arm (Other)

结局指标

主要结局

Number of clinic visits per patient

时间窗: 6 months

The number of clinic follow up visits in the observation period

次要结局

  • Hospitalisation due to deterioration of allograft function(6 Months)
  • Number of patients where symptoms were recorded accurately on the questionnaire(6 months)
  • Number of unplanned clinic visits per patient(6 months)
  • Duration of hospitalisations due to deterioration of allograft function(6 Months)
  • Number of planned clinic visits per patient(6 Months)
  • "Measuring the Utilization Rate of Remote Monitoring for Patient Engagement" "Measuring the Utilization Rate of Remote Monitoring for Patient Engagement" Number of patient interactions with the remote monitoring platform(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Blaikley

Senior Lecturer

University of Manchester

研究点 (1)

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