COPDEARLYNCT03620630
Clinical Efficacy and Cost Effectiveness of MYCOPD in Patients With Mild and Moderate Newly Diagnosed COPD
A study testing myCOPD in people with COPD, run by my mhealth Ltd at 1 site in United Kingdom.
Trial summary
Millions of patients in the UK live with long term medical conditions such as diabetes, heart disease and lung diseases. These conditions are the major cause of ill health in the UK and cost the NHS billions of pounds each year. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- myCOPD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2018to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 40-80 years able to give written informed consent
- Confirmed diagnosis of mild or moderate COPD or diagnosed in the last 12 months with a confirmed diagnosis of COPD.
- FEV1 percent predicted value greater than 50% (Mild or Moderate COPD)
- Current or ex smoker
- FEV1/VC or FEV1/FVC Ratio less than 70%
- Currently taking inhaled medications
- Access to the internet at home, use of mobile technology and the ability to operate a web platform in English
- Consent to be contacted by phone, text and email.
Who cannot join
- FEV1 percent predicted less than 49% unless diagnosed in the last 12 months
- COPD exacerbation in the past 4 weeks
- Housebound patients
- Patients unable to read or use an internet enabled device.
- Alcohol and drug misuse
- Presence of a medical condition other than COPD which investigators feel would confound study outcome collection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
my mhealth Limited
Bournemouth, Hampshire, BH1 1JU
About this study
Official title: Evidence Generation for the Clinical Efficacy and Cost Effectiveness of myCOPD in Patients With Mild and Moderate Newly Diagnosed COPD
Millions of patients in the UK live with long term medical conditions such as diabetes, heart disease and lung diseases. These conditions are the major cause of ill health in the UK and cost the NHS billions of pounds each year. One long term condition that carries an enormous impact for patients and the NHS is COPD (Chronic Obstructive Pulmonary Disease). This lung condition affects over one million patients in the UK and is one of the major causes of admission to hospital.
Involvement of patients in the management of their own medical conditions (self-care) has been shown to improve how individuals feel, reduce the frequency of medical emergencies and reduce the costs of health care. In order to self-care successfully patients require the correct knowledge, skills and the confidence to make the right decisions; about their treatments, use of healthcare services and lifestyle choices. Recently the use of digital tools such as apps and websites has been shown to help patients with self-care and thus to improve their health. However in the UK there are very few providers of apps that are fully accredited by the NHS and only one that has been fully funded to provide apps nationally.
Read more
My mhealth (short for my mobile health) is a UK company founded by NHS doctors which provides high quality digital tools (apps) to enable patients to access information about their condition and treatments and to record symptoms on their phones, tablets, computers or even smart TVs. MyMHealth has produced an app called MyCOPD which has been issued by the NHS to many thousands of patients in the UK. This was because it has been shown to improve the way patients with more severe COPD use their treatment and improved their day to day function through use of an online exercise programme.
In this proposed study the MyMHealth team will work with NHS professionals to explore how an app called MyCOPD could help patients with mild disease and particularly those newly diagnosed with the condition. Investigators will explore how these patients can use the app and whether it's use can improve the ability to self-manage their condition. Investigators will study the potential for the app to establish appropriate and active decision making by patients and the impact of this on the use of NHS resources and the costs of day to day care.
Read the detailed description
COPD is a disabling, smoking related lung disease that is associated with symptoms of shortness of breath, cough and wheeze. The natural history is one of progressive decline, frequently punctuated by periods of rapid worsening termed acute exacerbations. The functional limitation experienced by individuals with COPD, their propensity to exacerbations and the high levels of psychological and physical co-morbidities place a significant burden on health and social care systems. It is estimated that COPD will become the 4th leading cause of death worldwide by 2030.
A typical UK city has over 7,500 patients with COPD on primary care registries and it is estimated that there are an additional 6,500 individuals living with the disease that have not yet been diagnosed. The NHS in England encourages opportunistic and systematic case finding to achieve early disease recognition. However, the merits of this approach are unclear due to a lack of evidence that early disease identification alters outcomes.
A recent randomised controlled trial undertaken in China has suggested that initiation of Tiotropium in patients with early disease may reduce the rate of lung function decline compared to placebo. This phenomenon was also observed in a subgroup analysis of young and milder COPD patients in the UPLIFT trial. Prior to these observations, smoking cessation was the only means of altering disease course in patients with early disease and there is conflicting evidence as to whether identifying COPD in smokers helps to achieve this or not. The possibility that early drug initiation may alter disease trajectory and improve long term health outcomes, makes early diagnosis appealing.
It is recognised that at the time of COPD diagnosis, patients are already less physically active than their peers that do not have airflow obstruction. This suggests that patients alter their behaviour to avoid symptoms before they perceive a problem significant enough to warrant medical attention. Physical inactivity is common in COPD patients and breathlessness is cited as the most common cause. Physical inactivity is one of the strongest predictors of death in COPD patients.To date, interventions that aim to increase physical activity have had limited success. This may be because interventions are targeted at patients with established disease when behaviour change is already established. We hypothesise that a better approach would be to prevent behaviour change in the first place rather than try to reverse it after it has occurred. Given the major barrier to physical activity is breathlessness and that this appears to impact individuals early in the disease, often before presentation, we propose that early intervention with therapies proven to reduce breathlessness will offer the greatest benefit.
Recent years have seen the development of new therapeutic strategies in COPD. A new class of inhaled therapy has emerged in the form of combined long acting beta-2 agonists (LABA) and long acting muscarinic receptor antagonists (LAMA). This dual bronchodilator approach achieves greater improvements in lung function, symptoms, quality of life and exacerbation frequency compared to the individual components alone. Early initiation of therapy with dual bronchodilation has the potential to prevent the reduction in physical activity that occurs due to exertional breathlessness and is now advocated as the first line treatment for COPD.
Therefore there is an increased need to explore strategies to support patients with mild, moderate and early COPD as the rationale for treatment develops. Here the evidence that self-management can play an important contribution to improving clinical outcomes whilst reducing health care resource use and associated costs is great. In order to effectively self-manage, patients require the knowledge, skills and confidence to make appropriate decisions about their care. When newly diagnosed, there are very few opportunities for patients to learn about their condition and develop the skills to case manage effectively. Consequently patients with LTC's often rely on health care professional to guide them and are unaware of appropriator measures they can take themselves to improve their own health. The use of digital technologies, particularly apps has been suggested as a way of empowering patients to self-manage effectively. The provision of high quality information and advice on medication, health promoting activities and improvements in adherence via apps can help patient gain the skills and confidence they need to effectively manage their conditions.
MyMHealth is a leading digital health provider that is one of the very few MHRA approved app developers and the only provider to be funded by NHS England through the National Innovation and Technology Tariff to provide patients with high quality apps to help them manage their health. MyCOPD is such a patient platform and the NHS and NICE approvals have led to the distribution of access licenses to over 50 000 patients with COPD in England. This product is therefore at the vanguard of the digital health revolution in the UK based on a strong evidence base of benefit in patient with established and more severe disease. However the majority of patients with COPD have milder disease and currently patients with mild to moderate or newly diagnosed COPD are not funded to receive the app as part of their routine care as the evidence base for its use is not mature. This study seeks to explore the potential for the use of MyCOPD to improve COPD patients' activation, disease knowledge and self-efficacy following diagnosis and in the context of mild and moderate disease.
- Conditions
- COPD
- Being tested
- myCOPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myCOPDDevice
myCOPD is a multi faceted web based application designed to support people with COPD in the Long term management of their COPD.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients allocated to usual care will continue with their current NHS management in line with national and local guidelines. |
| myCOPD | Active comparator | Patients allocated to the myCOPD arm will receive access to a web based application called myCOPD Receives: Device: myCOPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test
This is a validated symptom scoring system used in COPD studies The CAT questionnaire contains eight questions and provides a reliable measure of the impact of COPD on health status. Patients read the two statements for each item, which describe the best and worst scenario, (e.g I never cough - I cough all the time), and decide where on the scale of 0-5 they fit. The maximum score is out of 40. The higher the CAT score the greater the impact of symptoms on their health status. Experts involved in the development of CAT suggest that any change of 2 or more in the patient's final score may indicate a clinically significant change. CAT will be recorded at the start prior to any intervention at visit one, at monthly telephone calls for the duration of the study and at end of study visit
Measured: 3 months
Secondary outcomes (6)
Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability)
Safety assessed by the incidence of treatment pathway emergent adverse event (AE's) and Serious Adverse Events (SAE's) at study completion. The number of adverse events and serious adverse events will be tabulated also by the number patients reporting an event.
Measured: 3 months
Patient Activation Measurement (PAM)
PAM is a tool used for measuring the level of patient engagement in their healthcare. It was designed to assess an individual's knowledge, skill and confidence for self-management. PAM is a 13-item scale that asks people about their beliefs, knowledge and confidence for engaging in a wide range of health behaviours and then assigns an activation score based on their responses to the 13-item scale.
Measured: 3 months
Health Economics Analysis
The measurement of health outcome used will be the Quality Adjusted Life Year (QALY) calculated using the EuroQol 5 Demension-5 Level questionnaire (EQ5D 5L).The EQ5D 5L is a validated questionnaire which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Minimum score is 5 and maximum score is 25 patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' score maximum 100 and 'The worst health you can imagine score minimum 0.The use of NHS resources from an adjusted baseline period prior to staring the study compared to during the study will be used as a comparator for cost outcomes
Measured: 3 months
Inhaler Technique
This will be assessed using the "7 Steps to successfully inhaler technique developed by the UK Inhaler Group. Each step is evaluated as being Good or Poor and the number of critical errors will be recorded.
Measured: 3 months
Self Efficacy for Appropriate medication use Scale (SEAMS)
Seams is a validated medication adherence questionnaire. Designed to indicate level of self efficacy for medication management. The questionnaire contains 13 questions with 3 levels of response Not confident, Somewhat confident and very confident. The minimum score is 13 and maximum score 39. The higher the score indicates greater level of self efficacy
Measured: 3 months
Change in Activity
Using FITBIT pedometers 12 patients from each arm will be allocated to activity monitoring to measure daily steps and improvement in total step count.
Measured: 7 days post baseline and 7 days prior to end of study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start9 Nov 2018
- Primary completion30 Sep 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled Feasibility study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- my mhealth Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovate UK, Imperial College London, Hull University Teaching Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Central London Community Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Tom Wilkinson, Study chair, my mhealth Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620630
- Sponsor's protocol ID
- MMH/RD/002
- Acronym
- EARLY
- Status last verified
- Feb 2020
- First submitted
- 17 Jul 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Callejas Gonzalez FJ, Genoves Crespo M, Cruz Ruiz J, Godoy Mayoral R, Agustin Martinez FJ, Martinez Garcia AJ, Tarraga Lopez PJ. UPLIFT study - understanding potential long-term impacts on function with tiotropium - and sub-analyses. Bibliographic resume of the obtained results. Expert Rev Respir Med. 2016 Sep;10(9):1023-33. doi: 10.1080/17476348.2016.1188693. Epub 2016 May 23.
PubMed 27176208Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
PubMed 18046898Lee SH, Kim KU, Lee H, Kim YS, Lee MK, Park HK. Factors associated with low-level physical activity in elderly patients with chronic obstructive pulmonary disease. Korean J Intern Med. 2018 Jan;33(1):130-137. doi: 10.3904/kjim.2016.090. Epub 2017 Jun 7.
PubMed 28602061WHO. (2008) COPD predicted to be third leading cause of death in 2030. [Online] Available at: http://www.who.int/respiratory/copd/World_Health_Statistics_2008/en/
Crooks, MG. Thompson, J. Platten, S. Evans, C. Faruqi, S. (2017) P25 Living with COPD: a Public Awareness and Screening Campaign. BMJ Thorax. [Online] 72(3). Available at: http://thorax.bmj.com/content/72/Suppl_3/A94.3
Lee HY, Choi SM, Lee J, Park YS, Lee CH, Kim DK, Lee SM, Yoon HI, Yim JJ, Kim YW, Han SK, Yoo CG. Effect of tiotropium on lung function decline in early-stage of chronic obstructive pulmonary disease patients: propensity score-matched analysis of real-world data. Int J Chron Obstruct Pulmon Dis. 2015 Oct 13;10:2185-92. doi: 10.2147/COPD.S91901. eCollection 2015.
PubMed 26508848Thabane M; COPD Working Group. Smoking cessation for patients with chronic obstructive pulmonary disease (COPD): an evidence-based analysis. Ont Health Technol Assess Ser. 2012;12(4):1-50. Epub 2012 Mar 1.
PubMed 23074432Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Benet M, Borrell E, Dadvand P, Foraster M, Marin A, Monteagudo M, Rodriguez-Roisin R, Vall-Casas P, Vilaro J, Garcia-Aymerich J; Urban Training Study Group. Socio-environmental correlates of physical activity in patients with chronic obstructive pulmonary disease (COPD). Thorax. 2017 Sep;72(9):796-802. doi: 10.1136/thoraxjnl-2016-209209. Epub 2017 Mar 1.
PubMed 28250201Waschki B, Kirsten A, Holz O, Muller KC, Meyer T, Watz H, Magnussen H. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest. 2011 Aug;140(2):331-342. doi: 10.1378/chest.10-2521. Epub 2011 Jan 27.
PubMed 21273294Mantoani LC, Rubio N, McKinstry B, MacNee W, Rabinovich RA. Interventions to modify physical activity in patients with COPD: a systematic review. Eur Respir J. 2016 Jul;48(1):69-81. doi: 10.1183/13993003.01744-2015. Epub 2016 Apr 21.
PubMed 27103381
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Generation for the Clinical Efficacy and Cost Effectiveness of myCOPD in Patients With Mild and Moderate Newly Diagnosed COPD
- ClinicalTrials.gov ID
- NCT03620630
- Acronym / sponsor ID
- EARLY / MMH/RD/002
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- my mhealth LtdIndustry (pharma, biotech, devices)
- Collaborators
- Innovate UK, Imperial College London, Hull University Teaching Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Central London Community Healthcare NHS Trust
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Millions of patients in the UK live with long term medical conditions such as diabetes, heart disease and lung diseases. These conditions are the major cause of ill health in the UK and cost the NHS billions of pounds each year. One long term condition that carries an enormous impact for patients and the NHS is COPD (Chronic Obstructive Pulmonary Disease). This lung condition affects over one million patients in the UK and is one of the major causes of admission to hospital.
Involvement of patients in the management of their own medical conditions (self-care) has been shown to improve how individuals feel, reduce the frequency of medical emergencies and reduce the costs of health care. In order to self-care successfully patients require the correct knowledge, skills and the confidence to make the right decisions; about their treatments, use of healthcare services and lifestyle choices. Recently the use of digital tools such as apps and websites has been shown to help patients with self-care and thus to improve their health. However in the UK there are very few providers of apps that are fully accredited by the NHS and only one that has been fully funded to provide apps nationally.
My mhealth (short for my mobile health) is a UK company founded by NHS doctors which provides high quality digital tools (apps) to enable patients to access information about their condition and treatments and to record symptoms on their phones, tablets, computers or even smart TVs. MyMHealth has produced an app called MyCOPD which has been issued by the NHS to many thousands of patients in the UK. This was because it has been shown to improve the way patients with more severe COPD use their treatment and improved their day to day function through use of an online exercise programme.
In this proposed study the MyMHealth team will work with NHS professionals to explore how an app called MyCOPD could help patients with mild disease and particularly those newly diagnosed with the condition. Investigators will explore how these patients can use the app and whether it's use can improve the ability to self-manage their condition. Investigators will study the potential for the app to establish appropriate and active decision making by patients and the impact of this on the use of NHS resources and the costs of day to day care.
Detailed description
COPD is a disabling, smoking related lung disease that is associated with symptoms of shortness of breath, cough and wheeze. The natural history is one of progressive decline, frequently punctuated by periods of rapid worsening termed acute exacerbations. The functional limitation experienced by individuals with COPD, their propensity to exacerbations and the high levels of psychological and physical co-morbidities place a significant burden on health and social care systems. It is estimated that COPD will become the 4th leading cause of death worldwide by 2030.
A typical UK city has over 7,500 patients with COPD on primary care registries and it is estimated that there are an additional 6,500 individuals living with the disease that have not yet been diagnosed. The NHS in England encourages opportunistic and systematic case finding to achieve early disease recognition. However, the merits of this approach are unclear due to a lack of evidence that early disease identification alters outcomes.
A recent randomised controlled trial undertaken in China has suggested that initiation of Tiotropium in patients with early disease may reduce the rate of lung function decline compared to placebo. This phenomenon was also observed in a subgroup analysis of young and milder COPD patients in the UPLIFT trial. Prior to these observations, smoking cessation was the only means of altering disease course in patients with early disease and there is conflicting evidence as to whether identifying COPD in smokers helps to achieve this or not. The possibility that early drug initiation may alter disease trajectory and improve long term health outcomes, makes early diagnosis appealing.
It is recognised that at the time of COPD diagnosis, patients are already less physically active than their peers that do not have airflow obstruction. This suggests that patients alter their behaviour to avoid symptoms before they perceive a problem significant enough to warrant medical attention. Physical inactivity is common in COPD patients and breathlessness is cited as the most common cause. Physical inactivity is one of the strongest predictors of death in COPD patients.To date, interventions that aim to increase physical activity have had limited success. This may be because interventions are targeted at patients with established disease when behaviour change is already established. We hypothesise that a better approach would be to prevent behaviour change in the first place rather than try to reverse it after it has occurred. Given the major barrier to physical activity is breathlessness and that this appears to impact individuals early in the disease, often before presentation, we propose that early intervention with therapies proven to reduce breathlessness will offer the greatest benefit.
Recent years have seen the development of new therapeutic strategies in COPD. A new class of inhaled therapy has emerged in the form of combined long acting beta-2 agonists (LABA) and long acting muscarinic receptor antagonists (LAMA). This dual bronchodilator approach achieves greater improvements in lung function, symptoms, quality of life and exacerbation frequency compared to the individual components alone. Early initiation of therapy with dual bronchodilation has the potential to prevent the reduction in physical activity that occurs due to exertional breathlessness and is now advocated as the first line treatment for COPD.
Therefore there is an increased need to explore strategies to support patients with mild, moderate and early COPD as the rationale for treatment develops. Here the evidence that self-management can play an important contribution to improving clinical outcomes whilst reducing health care resource use and associated costs is great. In order to effectively self-manage, patients require the knowledge, skills and confidence to make appropriate decisions about their care. When newly diagnosed, there are very few opportunities for patients to learn about their condition and develop the skills to case manage effectively. Consequently patients with LTC's often rely on health care professional to guide them and are unaware of appropriator measures they can take themselves to improve their own health. The use of digital technologies, particularly apps has been suggested as a way of empowering patients to self-manage effectively. The provision of high quality information and advice on medication, health promoting activities and improvements in adherence via apps can help patient gain the skills and confidence they need to effectively manage their conditions.
MyMHealth is a leading digital health provider that is one of the very few MHRA approved app developers and the only provider to be funded by NHS England through the National Innovation and Technology Tariff to provide patients with high quality apps to help them manage their health. MyCOPD is such a patient platform and the NHS and NICE approvals have led to the distribution of access licenses to over 50 000 patients with COPD in England. This product is therefore at the vanguard of the digital health revolution in the UK based on a strong evidence base of benefit in patient with established and more severe disease. However the majority of patients with COPD have milder disease and currently patients with mild to moderate or newly diagnosed COPD are not funded to receive the app as part of their routine care as the evidence base for its use is not mature. This study seeks to explore the potential for the use of MyCOPD to improve COPD patients' activation, disease knowledge and self-efficacy following diagnosis and in the context of mild and moderate disease.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients allocated to usual care will continue with their current NHS management in line with national and local guidelines. |
| myCOPD | Active comparator | Device: myCOPDPatients allocated to the myCOPD arm will receive access to a web based application called myCOPD |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients aged 40-80 years able to give written informed consent
- Confirmed diagnosis of mild or moderate COPD or diagnosed in the last 12 months with a confirmed diagnosis of COPD.
- FEV1 percent predicted value greater than 50% (Mild or Moderate COPD)
- Current or ex smoker
- FEV1/VC or FEV1/FVC Ratio less than 70%
Key exclusion criteria (6 listed)
- FEV1 percent predicted less than 49% unless diagnosed in the last 12 months
- COPD exacerbation in the past 4 weeks
- Housebound patients
- Patients unable to read or use an internet enabled device.
- Alcohol and drug misuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myCOPDmyCOPD is a multi faceted web based application designed to support people with COPD in the Long term management of their COPD. | Device | myCOPD |
Primary outcome
COPD Assessment Test
Time frame: 3 months
This is a validated symptom scoring system used in COPD studies The CAT questionnaire contains eight questions and provides a reliable measure of the impact of COPD on health status. Patients read the two statements for each item, which describe the best and worst scenario, (e.g I never cough - I cough all the time), and decide where on the scale of 0-5 they fit. The maximum score is out of 40. The higher the CAT score the greater the impact of symptoms on their health status. Experts involved in the development of CAT suggest that any change of 2 or more in the patient's final score may indicate a clinically significant change. CAT will be recorded at the start prior to any intervention at visit one, at monthly telephone calls for the duration of the study and at end of study visit
6 secondary outcomes
Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability)
Time frame: 3 months
Patient Activation Measurement (PAM)
Time frame: 3 months
Health Economics Analysis
Time frame: 3 months
Inhaler Technique
Time frame: 3 months
Self Efficacy for Appropriate medication use Scale (SEAMS)
Time frame: 3 months
Change in Activity
Time frame: 7 days post baseline and 7 days prior to end of study visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 27176208Callejas Gonzalez FJ, Genoves Crespo M, Cruz Ruiz J, Godoy Mayoral R, Agustin Martinez FJ, Martinez Garcia AJ, Tarraga Lopez PJ. UPLIFT study - understanding potential long-term impacts on function with tiotropium - and sub-analyses. Bibliographic resume of the obtained results. Expert Rev Respir Med. 2016 Sep;10(9):1023-33. doi: 10.1080/17476348.2016.1188693. Epub 2016 May 23.
- Background: PubMed 18046898Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
- Background: PubMed 28602061Lee SH, Kim KU, Lee H, Kim YS, Lee MK, Park HK. Factors associated with low-level physical activity in elderly patients with chronic obstructive pulmonary disease. Korean J Intern Med. 2018 Jan;33(1):130-137. doi: 10.3904/kjim.2016.090. Epub 2017 Jun 7.
- Results publicationWHO. (2008) COPD predicted to be third leading cause of death in 2030. [Online] Available at: http://www.who.int/respiratory/copd/World_Health_Statistics_2008/en/
- Results publicationCrooks, MG. Thompson, J. Platten, S. Evans, C. Faruqi, S. (2017) P25 Living with COPD: a Public Awareness and Screening Campaign. BMJ Thorax. [Online] 72(3). Available at: http://thorax.bmj.com/content/72/Suppl_3/A94.3
- Results publication: PubMed 26508848Lee HY, Choi SM, Lee J, Park YS, Lee CH, Kim DK, Lee SM, Yoon HI, Yim JJ, Kim YW, Han SK, Yoo CG. Effect of tiotropium on lung function decline in early-stage of chronic obstructive pulmonary disease patients: propensity score-matched analysis of real-world data. Int J Chron Obstruct Pulmon Dis. 2015 Oct 13;10:2185-92. doi: 10.2147/COPD.S91901. eCollection 2015.
- Results publication: PubMed 23074432Thabane M; COPD Working Group. Smoking cessation for patients with chronic obstructive pulmonary disease (COPD): an evidence-based analysis. Ont Health Technol Assess Ser. 2012;12(4):1-50. Epub 2012 Mar 1.
- Results publication: PubMed 28250201Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Benet M, Borrell E, Dadvand P, Foraster M, Marin A, Monteagudo M, Rodriguez-Roisin R, Vall-Casas P, Vilaro J, Garcia-Aymerich J; Urban Training Study Group. Socio-environmental correlates of physical activity in patients with chronic obstructive pulmonary disease (COPD). Thorax. 2017 Sep;72(9):796-802. doi: 10.1136/thoraxjnl-2016-209209. Epub 2017 Mar 1.
- Results publication: PubMed 21273294Waschki B, Kirsten A, Holz O, Muller KC, Meyer T, Watz H, Magnussen H. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest. 2011 Aug;140(2):331-342. doi: 10.1378/chest.10-2521. Epub 2011 Jan 27.
- Results publication: PubMed 27103381Mantoani LC, Rubio N, McKinstry B, MacNee W, Rabinovich RA. Interventions to modify physical activity in patients with COPD: a systematic review. Eur Respir J. 2016 Jul;48(1):69-81. doi: 10.1183/13993003.01744-2015. Epub 2016 Apr 21.
- Individual participant dataSharing planned: No
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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Wilkinson study chair
my mhealth Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myCOPD in people with COPD, run by my mhealth Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment Test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620630, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.