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

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ClinicalTrials.gov Identifier: NCT02300090
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Device: Test Group Other: Control Group

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 161 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).
Actual Study Start Date : October 26, 2016
Actual Primary Completion Date : August 23, 2018
Actual Study Completion Date : August 23, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females, of any age with a clinical diagnosis of COPD
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300090


Locations
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United Kingdom
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: David MG Halpin, MBBS, MRCP, FRCP Royal Devon and Exeter Hospital

Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02300090     History of Changes
Other Study ID Numbers: 149902
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: August 2018

Keywords provided by AstraZeneca:
COPD, Exacerbation, respiratory disease, lung disease, breathlessness, dyspnoea, sputum, wheezing, cough

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases