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NCT02300090 Clinical Trial

A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

— Me&MyCOPD  

Official title:
A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02300090
Other study ID # 149902
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2016
Est. completion date August 23, 2018

Study information
Verified date August 2018
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date August 23, 2018
Est. primary completion date August 23, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Test Group
Patients receive a mobile phone with the Me & My COPD app installed. Patients also receive a bluetooth inhaler device that is fitted to their usual reliever inhaler.
Other:
• Control Group
Patients in the control group receive only standard care; there are no interventions within this group of patients

Locations
Country Name City State
United Kingdom Research Site East Cheshire UK
United Kingdom Research Site East Cheshire UK
United Kingdom Research Site East Cheshire UK
United Kingdom Research Site East Cheshire UK
United Kingdom Research Site East Cheshire UK
United Kingdom Research Site East Cheshire UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Liverpool UK
United Kingdom Research Site Manchester UK
United Kingdom Research Site Manchester UK
United Kingdom Research Site Newcastle UK
United Kingdom Research Site Newcastle UK
United Kingdom Research Site Oldham UK
United Kingdom Research Site Oldham UK
United Kingdom Research Site Oldham UK
United Kingdom Research Site Oldham UK

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other To detect a difference in the use/prescribing of maintenance therapy To detect a difference in the use/prescribing of maintenance therapies (inhaled corticosteroids/long acting beta agonists and or long acting muscarinic antagonists) by comparison of repeat prescriptions across patients receiving the digital service and those receiving current best care alone. 12 months
Other To detect a difference in the use/prescribing of reliever therapy To detect a difference in the use/prescribing of reliever therapy, as measured through repeat prescriptions, by comparison of patients receiving the digital service and those receiving current best care. 12 months
Other To assess patinet engagement in the use of the digital service To assess the engagement of patients receiving the digital service as measured by frequency of access to infromational content and goal management. 12 months
Primary To detect a reduction in the rate of hospitalisations due to COPD exacerbations The mean number of COPD related hospitalisations per patient per year for patients who are receiving the digital service in the study will be compared to the rate of COPD related hospitalisations in patients receiving current best care alone over a twelve period. Analysed over a twelve month timeframe
Secondary To detect a reduction in the duration of hospitalisations due to COPD exacerbations. The average duration of COPD related hopspitalisations (number of bed days) per patient will be compared across patients receiving the digital service and those receiving current best care alone. 12 months
Secondary To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods The number of exacerbations requiring treament with antibiotics and or systemic steriods will be compared across patients receiving the digital service and those receiving current best care alone. 12 months
Secondary To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C The patients assessment of their own health status will be assessed over time using the St Georges Respiratory Questionnaire-C, and will be compared across patients receiving the digital service and those receiving current best care alone. 12 months
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