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

September 9, 2018 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • UK
      • East Cheshire, UK, United Kingdom, CW12 1JN
        • Research Site
      • East Cheshire, UK, United Kingdom, SK10 5JH
        • Research Site
      • East Cheshire, UK, United Kingdom, SK11 6JL
        • Research Site
      • East Cheshire, UK, United Kingdom, SK12 1EU
        • Research Site
      • East Cheshire, UK, United Kingdom, SK12 1GP
        • Research Site
      • East Cheshire, UK, United Kingdom, SK12 2BB
        • Research Site
      • Liverpool, UK, United Kingdom, CH42 0LQ
        • Research Site
      • Liverpool, UK, United Kingdom, CH45 3HE
        • Research Site
      • Liverpool, UK, United Kingdom, CH45 3HF
        • Research Site
      • Liverpool, UK, United Kingdom, CH45 4JG
        • Research Site
      • Liverpool, UK, United Kingdom, CH45 5LN
        • Research Site
      • Liverpool, UK, United Kingdom, CH48 4HZ
        • Research Site
      • Liverpool, UK, United Kingdom, CH49 5PL
        • Research Site
      • Liverpool, UK, United Kingdom, CH63 2LR
        • Research Site
      • Liverpool, UK, United Kingdom, CH63 9JP
        • Research Site
      • Manchester, UK, United Kingdom, BL9 0NJ
        • Research Site
      • Manchester, UK, United Kingdom, M33 4BR
        • Research Site
      • Newcastle, UK, United Kingdom, NE15 6TQ
        • Research Site
      • Newcastle, UK, United Kingdom, NE15 8LX
        • Research Site
      • Oldham, UK, United Kingdom, OL8 3HH
        • Research Site
      • Oldham, UK, United Kingdom, OL9 0LH
        • Research Site
      • Oldham, UK, United Kingdom, OL9 7SG
        • Research Site
      • Oldham, UK, United Kingdom, OL9 8NH
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Males and females, of any age with a clinical diagnosis of COPD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention group
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.
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.
Control group
This group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service.
Other: Control Group
Patients in the control group receive only standard care; there are no interventions within this group of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Analysed over a twelve month timeframe

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: David MG Halpin, MBBS, MRCP, FRCP, Royal Devon and Exeter Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

August 23, 2018

Study Completion (Actual)

August 23, 2018

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Test Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe