Chronic Obstructive Pulmonary Disease Clinical Trial
— Me&MyCOPDOfficial title:
A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).
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 |
Verified date | August 2018 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United Kingdom,
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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