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Completed

NCT Number: NCT02300090

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Cough Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, East Cheshire, UK, United Kingdom

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test Group

Device

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.

Control Group

Other

Patients in the control group receive only standard care; there are no interventions within this group of patients

Primary outcomes

  1. To detect a reduction in the rate of hospitalisations due to COPD exacerbations

    Time frame: Analysed over a twelve month timeframe

    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.

Secondary outcomes

  1. To detect a reduction in the duration of hospitalisations due to COPD exacerbations.

    Time frame: 12 months

    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.

  2. To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods

    Time frame: 12 months

    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.

  3. To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C

    Time frame: 12 months

    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.

Other outcomes

  1. To detect a difference in the use/prescribing of maintenance therapy

    Time frame: 12 months

    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.

  2. To detect a difference in the use/prescribing of reliever therapy

    Time frame: 12 months

    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.

  3. To assess patinet engagement in the use of the digital service

    Time frame: 12 months

    To assess the engagement of patients receiving the digital service as measured by frequency of access to infromational content and goal management.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: Me&MyCOPD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2014
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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