Clinical trial NCT02300090: A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD)
Official title: A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Exacerbation, respiratory disease, lung disease, breathlessness, dyspnoea, sputum, wheezing, cough
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females, of any age with a clinical diagnosis of COPD

Brief summary: A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.

Detailed description: The purpose of the study is to evaluate a digital health wellness support tool for patients in primary care with COPD using a smart mobile app, patient web portal and technology attached to the patients SABA reliever inhaler. Using the patients pre-defined COPD self management plan, the active arm of the study complete a daily diary (EXACT PRO) and record their daily SABA inhaler usage. After defining a health and symptom score baseline over a two week period, any significant deviations in SABA reliever use or daily diary scoring will alert patients that they may be having a change in their symptoms and advise them to refer to their self management plan and if they need to start their rescue medication. The primary outcome measure for the study is a 25% reduction in unplanned COPD hospital admissions (n=250 completing the study in each arm).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD
* FEV1/FVC ratio \>0.3-\<0.7 and FEV1 \> 30% post-bronchodilator
* Prescribed either ICS, LABA and or LAMA at dose for COPD
* Exacerbations reported within the last 12 months requiring treatment with \>1 systemic steroid and/or antibiotics, OR hospitalisation within last 12 months due to exacerbation, OR have received \>12 SABA prescriptions in previous 12 months
* Patient has a self management plan which includes use of an oral steroid at a dose within NICE guidelines, and additionally antibiotics as appropriate.

Exclusion Criteria:

* Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months
* Patients unable to use a mobile phone

Primary outcomes:
measure: To detect a reduction in the rate of hospitalisations due to COPD exacerbations
timeFrame: Analysed over a twelve month timeframe
Secondary outcomes:
measure: To detect a reduction in the duration of hospitalisations due to COPD exacerbations.
timeFrame: 12 months
measure: To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods
timeFrame: 12 months
measure: To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C
timeFrame: 12 months
Other outcomes:
measure: To detect a difference in the use/prescribing of maintenance therapy
timeFrame: 12 months
measure: To detect a difference in the use/prescribing of reliever therapy
timeFrame: 12 months
measure: To assess patinet engagement in the use of the digital service
timeFrame: 12 months
Locations:
city: East Cheshire
country: United Kingdom
facility: Research Site
state: UK
city: East Cheshire
country: United Kingdom
facility: Research Site
state: UK
city: East Cheshire
country: United Kingdom
facility: Research Site
state: UK
city: East Cheshire
country: United Kingdom
facility: Research Site
state: UK
city: East Cheshire
country: United Kingdom
facility: Research Site
state: UK
city: East Cheshire
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Liverpool
country: United Kingdom
facility: Research Site
state: UK
city: Manchester
country: United Kingdom
facility: Research Site
state: UK
city: Manchester
country: United Kingdom
facility: Research Site
state: UK
city: Newcastle
country: United Kingdom
facility: Research Site
state: UK
city: Newcastle
country: United Kingdom
facility: Research Site
state: UK
city: Oldham
country: United Kingdom
facility: Research Site
state: UK
city: Oldham
country: United Kingdom
facility: Research Site
state: UK
city: Oldham
country: United Kingdom
facility: Research Site
state: UK
city: Oldham
country: United Kingdom
facility: Research Site
state: UK
Study officials:
affiliation: Royal Devon and Exeter Hospital
name: David MG Halpin, MBBS, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
References: