RESCUE-COPD 1 Randomised Trial of E-Health Platform Supported Care vs Usual Care After Exacerbation of COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Inhaler technique
研究概览
简要总结
There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such as chronic cough, breathlessness and reduced tolerance to exercise. National Institute for Health and Care Excellence (NICE) recommends that patients with COPD have a self management plan (SMP). The utilisation of SMP's has been shown to reduce healthcare utilisation, improve quality of life, and reduces the need for hospitalisation. Currently SMP's are delivered to patient in a paper format, myCOPD is a web based self management system which has been developed by Healthcare professional and patients encompasses the principles of Self management and offers a viable solution to a national recommendation.
The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 4 visits for the duration of the study.
The screening visits will comprise of written or verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment and delivery of either a written self management plan. The telephone visits will comprise of verbal consent and completion of the COPD Assessment Test. The End of Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique.
详细描述
The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 6 visits for the duration of the study.
Visit One - Screening Visit This visit will take place within two weeks of discharge from hospital in the participants home and comprise of written informed consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment This will be assessed using the critical errors list for each inhaler devices. Participants will also have their technique using each of their devices videoed. Those that fore fill inclusion and exclusion criteria will then be randomised in one of two groups, those receiving paper self management and those receiving online self management 'myCOPD'. For those receiving written self management The study nurse will complete with the participant a written self management plan. For those randomised to online self management they will be loan an android/iOS tablet computer and be given unique access codes and directed to the online 'How to tutorials .
Visit Two,Three - Telephone Visits There will be 2 telephone visits during the study and will comprise of verbal consent completion of the COPD Assessment Test and adverse event reporting.
Visit Four - End of Study Visit This visit will take place in the participants home and comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique. This will be assessed using the critical errors list for each inhaler devices and technique will be videoed. Participants will also be asked to complete a feedback questionnaire to evaluate user experience. Those allocated online will have their tablet computers collected by the study team and have a written self management plan delivered.
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 (Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects able to complete all study procedures and give written informed consent.
- •A diagnosis of COPD defined as per the NICE COPD guidelines
- •Male or female volunteers aged 45+ admitted to hospital or the ambulatory care service with a primary diagnosis of acute exacerbation of COPD
- •Patients who are taking inhaled therapies for COPD
- •Current or ex-smokers with a pack year history of more than 10 years
- •Access to the internet and ability to operate web platform and or use written action plan
排除标准
- •Patients who have any another respiratory disease as their main complaint such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
- •Patients unable to read or use an Internet enabled device.
- •Patients with any uncontrolled medical condition which in the view of the principle investigator or their team would confound the impact of a COPD directed support tool.
结局指标
主要结局
Inhaler technique
时间窗: 3 months
As different inhaled medication devices require different techniques, each participant's inhaler technique will be assessed according to manufactures guidelines for each device and critical errors recorded. Their technique will be video recorded at visit one and visit two. Any changes to devices during the study will be recorded prior to starting any new treatment. Each participant's technique will be evaluated and the number of critical errors recorded for each device and a composite . Each device will have its own critical error list we have created based on manufactures guidelines. Participants technique will be videoed and assessed using a critical error list for each device by a Health care Professional. This assessment will take place at visit one prior to intervention and 3 months post intervention at visit 4. The difference in the number of errors for each device pre and post intervention will then be recorded.
COPD Assessment Test (CAT)
时间窗: 3 months
This is a validated symptom scoring system used in COPD studies9 The CAT questionnaire contains eight questions and provides a reliable measure of the impact of COPD on health status. Patients read the two statements for each item, which describe the best and worst scenario, (e.g I never cough - I cough all the time), and decide where on the scale of 0-5 they fit. The maximum score is out of 40. The higher the CAT score the greater the impact of symptoms on their health status. Experts involved in the development of CAT suggest that any change of 2 or more in the patient's final score may indicate a clinically significant change. CAT will be recorded at the start prior to any intervention at visit one and 3 months post intervention at visit 4
次要结局
- Hospital Anxiety and Depression Score (HAD)(3 months)
- Veterans Specific Activity Questionnaire (VSAQ)(3 months)
- Patient Activation Measure (PAM)(3 months)
- St Georges Respiratory Questionnaire (SGRQ)(3 months)
- modified MRC(3 months)
- Work Productivity Activity Impairment (WPAI)(3 months)
- Admission and readmission data(3 months)
- Exacerbation History(3 months)