Chronic Obstructive Pulmonary Diseases Clinical Trial
Official title:
RESCUE-COPD 1 Randomised Trial of E-Health Platform Supported Care vs Usual Care After Exacerbation of COPD
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
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