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

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Control Group; Device: Test Group

Study type: Observational

Funder types: Industry

Identifiers

NCT02300090

149902

Details and patient eligibility

About

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

Full 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).

Enrollment: 161 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

161 participants in 2 patient groups

Intervention group

Description:

This group of patients (n=250) will receive the digital service (smart phone application and bluetooth inhaler device) in addition to current best care from their healthcare professional.

Treatment:

Device: Test Group

Control group

Description:

This group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service.

Treatment:

Other: Control Group