Trial of E-Health Platform Supported Care vs Usual Care After Exacerbation of COPD (RESCUE)

my mhealth

Status: Completed

Conditions: Chronic Obstructive Pulmonary Diseases

Treatments: Behavioral: Written Self management plan; Behavioral: myCOPD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02706600

PHT/2015/039

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects able to complete all study procedures and give written informed consent.
2. A diagnosis of COPD defined as per the NICE COPD guidelines
3. Male or female volunteers aged 45+ admitted to hospital or the ambulatory care service with a primary diagnosis of acute exacerbation of COPD
4. Patients who are taking inhaled therapies for COPD
5. Current or ex-smokers with a pack year history of more than 10 years
6. Access to the internet and ability to operate web platform and or use written action plan

Exclusion criteria

1. Patients who have any another respiratory disease as their main complaint such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
2. Patients unable to read or use an Internet enabled device.
3. 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Written Self Management

Other group

Description:

The HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate.

Treatment:

Behavioral: Written Self management plan

Online Self Management

Active Comparator group

Description:

myCOPD is a system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD. Medication and symptom diaries. Appointment diary, pulmonary rehabilitation videos to promote and support exercises that can be done in the home. Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA. A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients.

Treatment:

Behavioral: myCOPD