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A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control group | This group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Males and females, of any age with a clinical diagnosis of COPD
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| Name | Affiliation | Role |
|---|---|---|
| David MG Halpin, MBBS, MRCP, FRCP | Royal Devon and Exeter Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | East Cheshire | UK | CW12 1JN | United Kingdom | ||
| Research Site |
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| Control Group | Other | Patients in the control group receive only standard care; there are no interventions within this group of patients |
|
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 | 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 |
| 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 |
| 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 |
| East Cheshire |
| UK |
| SK10 5JH |
| United Kingdom |
| Research Site | East Cheshire | UK | SK11 6JL | United Kingdom |
| Research Site | East Cheshire | UK | SK12 1EU | United Kingdom |
| Research Site | East Cheshire | UK | SK12 1GP | United Kingdom |
| Research Site | East Cheshire | UK | SK12 2BB | United Kingdom |
| Research Site | Liverpool | UK | CH42 0LQ | United Kingdom |
| Research Site | Liverpool | UK | CH45 3HE | United Kingdom |
| Research Site | Liverpool | UK | CH45 3HF | United Kingdom |
| Research Site | Liverpool | UK | CH45 4JG | United Kingdom |
| Research Site | Liverpool | UK | CH45 5LN | United Kingdom |
| Research Site | Liverpool | UK | CH48 4HZ | United Kingdom |
| Research Site | Liverpool | UK | CH49 5PL | United Kingdom |
| Research Site | Liverpool | UK | CH63 2LR | United Kingdom |
| Research Site | Liverpool | UK | CH63 9JP | United Kingdom |
| Research Site | Manchester | UK | BL9 0NJ | United Kingdom |
| Research Site | Manchester | UK | M33 4BR | United Kingdom |
| Research Site | Newcastle | UK | NE15 6TQ | United Kingdom |
| Research Site | Newcastle | UK | NE15 8LX | United Kingdom |
| Research Site | Oldham | UK | OL8 3HH | United Kingdom |
| Research Site | Oldham | UK | OL9 0LH | United Kingdom |
| Research Site | Oldham | UK | OL9 7SG | United Kingdom |
| Research Site | Oldham | UK | OL9 8NH | United Kingdom |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012120 | Respiration Disorders |
| D008171 | Lung Diseases |
| D004417 | Dyspnea |
| D012135 | Respiratory Sounds |
| D003371 | Cough |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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