Chronic Obstructive Pulmonary DiseasesRESCUENCT02706600
Trial of E-Health Platform Supported Care vs Usual Care After Exacerbation of COPD
A study testing myCOPD and Written Self management plan in people with Chronic Obstructive Pulmonary Diseases, run by my mhealth Ltd at 1 site in United Kingdom.
Trial summary
There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such as chronic cough, breathlessness and reduced tolerance to exercise. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Diseases
- What is being tested?
- myCOPD and Written Self management plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Mar 2016
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects able to complete all study procedures and give written informed consent.
- A diagnosis of COPD defined as per the NICE COPD guidelines
- Male or female volunteers aged 45+ admitted to hospital or the ambulatory care service with a primary diagnosis of acute exacerbation of COPD
- Patients who are taking inhaled therapies for COPD
- Current or ex-smokers with a pack year history of more than 10 years
- Access to the internet and ability to operate web platform and or use written action plan
Who cannot join
- Patients who have any another respiratory disease as their main complaint such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
- Patients unable to read or use an Internet enabled device.
- Patients with any uncontrolled medical condition which in the view of the principle investigator or their team would confound the impact of a COPD directed support tool.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospital NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: RESCUE-COPD 1 Randomised Trial of E-Health Platform Supported Care vs Usual Care After Exacerbation of COPD
There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such as chronic cough, breathlessness and reduced tolerance to exercise. National Institute for Health and Care Excellence (NICE) recommends that patients with COPD have a self management plan (SMP). The utilisation of SMP's has been shown to reduce healthcare utilisation, improve quality of life, and reduces the need for hospitalisation. Currently SMP's are delivered to patient in a paper format, myCOPD is a web based self management system which has been developed by Healthcare professional and patients encompasses the principles of Self management and offers a viable solution to a national recommendation.
The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 4 visits for the duration of the study.
The screening visits will comprise of written or verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment and delivery of either a written self management plan. The telephone visits will comprise of verbal consent and completion of the COPD Assessment Test. The End of Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique.
Read the detailed description
The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 6 visits for the duration of the study.
Visit One - Screening Visit This visit will take place within two weeks of discharge from hospital in the participants home and comprise of written informed consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment This will be assessed using the critical errors list for each inhaler devices. Participants will also have their technique using each of their devices videoed. Those that fore fill inclusion and exclusion criteria will then be randomised in one of two groups, those receiving paper self management and those receiving online self management 'myCOPD'. For those receiving written self management The study nurse will complete with the participant a written self management plan. For those randomised to online self management they will be loan an android/iOS tablet computer and be given unique access codes and directed to the online 'How to tutorials .
Visit Two,Three - Telephone Visits There will be 2 telephone visits during the study and will comprise of verbal consent completion of the COPD Assessment Test and adverse event reporting.
Visit Four - End of Study Visit This visit will take place in the participants home and comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique. This will be assessed using the critical errors list for each inhaler devices and technique will be videoed. Participants will also be asked to complete a feedback questionnaire to evaluate user experience. Those allocated online will have their tablet computers collected by the study team and have a written self management plan delivered.
- Conditions
- Chronic Obstructive Pulmonary Diseases
- Being tested
- myCOPD, Written Self management plan
- 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.
myCOPDBehavioural
myCOPD is a system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD.
Medication and symptom diaries. Appointment diary Bitesize pulmonary rehabilitation videos designed to promote and support exercises that can be done in a home setting.
Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA.
A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients.
Written Self management planBehavioural
The HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate.
| Study group | Role | What they receive |
|---|---|---|
| Written Self Management | Other | The HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. Receives: Behavioral: Written Self management plan |
| Online Self Management | Active comparator | myCOPD is a system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD.
Medication and symptom diaries. Appointment diary, pulmonary rehabilitation videos to promote and support exercises that can be done in the home.
Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA.
A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients. Receives: Behavioral: myCOPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test (CAT)
This is a validated symptom scoring system used in COPD studies9 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 and 3 months post intervention at visit 4
Measured: 3 months
Inhaler technique
As different inhaled medication devices require different techniques, each participant's inhaler technique will be assessed according to manufactures guidelines for each device and critical errors recorded. Their technique will be video recorded at visit one and visit two. Any changes to devices during the study will be recorded prior to starting any new treatment. Each participant's technique will be evaluated and the number of critical errors recorded for each device and a composite . Each device will have its own critical error list we have created based on manufactures guidelines. Participants technique will be videoed and assessed using a critical error list for each device by a Health care Professional. This assessment will take place at visit one prior to intervention and 3 months post intervention at visit 4. The difference in the number of errors for each device pre and post intervention will then be recorded.
Measured: 3 months
Secondary outcomes (8)
St Georges Respiratory Questionnaire (SGRQ)
The SGRQ questionnaire has 50 items with 76 weighted responses. It has good discriminative and evaluative properties and is responsive to therapeutic trials. It was developed and validated in both asthma and COPD and designed to measure the health impairment of patients with respiratory disease. We will be assessed at visit one prior to intervention and 3 months post intervention
Measured: 3 months
modified MRC
The mMRC dyspnoea scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). It can be self-administered by asking subjects to choose a phrase that best describes their degree of breathlessness associated with activity. This will be assessed prior to and three months post intervention
Measured: 3 months
Hospital Anxiety and Depression Score (HAD)
This clinical scale was developed in 1983 and is in common use in clinical and trial settings. It consists of 7 questions scored form 0-3 to create a score out of 21. It is easily administered and has been well validated for the assessment of patients with COPD. This will be assessed prior to and three months after intervention
Measured: 3 months
Patient Activation Measure (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 behaviors and then assigns an activation score based on their responses to the 13-item scale. This will be assessed prior to and three months post intervention.
Measured: 3 months
Work Productivity Activity Impairment (WPAI)
The Work Productivity and Activity Impairment (WPAI) questionnaire is a well validated instrument to measure impairments in work and activities. The 6 questions relate to work absenteeism (hours missed work) Work presenteeism (impairment whilst working) and work productivity lost due to a health condition. This will be assessed prior to and three months post intervention
Measured: 3 months
Veterans Specific Activity Questionnaire (VSAQ)
The VSAQ is validated Self administered questionnaire developed to estimate exercise capacity for the development of exercise prescription. The VSAQ consists of physical activities listed in progressive order according to their energy demand estimated by metabolic equivalents (METs). One MET is equal to resting oxygen consumption 3.5 ml/kg/min. Therefore, numbers of METs express the energy cost of physical activities as a multiple of the resting metabolic rate. This will be assessed prior to and three months post intervention
Measured: 3 months
Exacerbation History
COPD exacerbation data will be collecting from their primary prescriber on their exacerbation history. The numbers of COPD exacerbations requiring oral antibiotics and/or oral steroids by the participants one year prior to starting the study will be recorded at visit one. If the participant has any exacerbations requiring oral antibiotics and/or steroids required during the period of the study this will be recorded at visit four.
Measured: 3 months
Admission and readmission data
Admission and readmission data will be collected at visit 1 and visit 4 and verified by the GP patient records or other source data.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- my mhealth Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Ben Green, Dr, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706600
- Sponsor's protocol ID
- PHT/2015/039
- Acronym
- RESCUE
- Status last verified
- Jul 2015
- First submitted
- 30 Jul 2015
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rice KL, Dewan N, Bloomfield HE, Grill J, Schult TM, Nelson DB, Kumari S, Thomas M, Geist LJ, Beaner C, Caldwell M, Niewoehner DE. Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):890-6. doi: 10.1164/rccm.200910-1579OC. Epub 2010 Jan 14.
PubMed 20075385Bourbeau J, Bartlett SJ. Patient adherence in COPD. Thorax. 2008 Sep;63(9):831-8. doi: 10.1136/thx.2007.086041.
PubMed 18728206Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PubMed 19720809Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.
PubMed 1759018Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
PubMed 23258783Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
PubMed 12622605
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESCUE-COPD 1 Randomised Trial of E-Health Platform Supported Care vs Usual Care After Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT02706600
- Acronym / sponsor ID
- RESCUE / PHT/2015/039
- Conditions
- Chronic Obstructive Pulmonary Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- my mhealth LtdIndustry (pharma, biotech, devices)
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Mar 2016 (estimated)
- 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.
There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such as chronic cough, breathlessness and reduced tolerance to exercise. National Institute for Health and Care Excellence (NICE) recommends that patients with COPD have a self management plan (SMP). The utilisation of SMP's has been shown to reduce healthcare utilisation, improve quality of life, and reduces the need for hospitalisation. Currently SMP's are delivered to patient in a paper format, myCOPD is a web based self management system which has been developed by Healthcare professional and patients encompasses the principles of Self management and offers a viable solution to a national recommendation.
The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 4 visits for the duration of the study.
The screening visits will comprise of written or verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment and delivery of either a written self management plan. The telephone visits will comprise of verbal consent and completion of the COPD Assessment Test. The End of Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique.
Detailed description
The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 6 visits for the duration of the study.
Visit One - Screening Visit This visit will take place within two weeks of discharge from hospital in the participants home and comprise of written informed consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment This will be assessed using the critical errors list for each inhaler devices. Participants will also have their technique using each of their devices videoed. Those that fore fill inclusion and exclusion criteria will then be randomised in one of two groups, those receiving paper self management and those receiving online self management 'myCOPD'. For those receiving written self management The study nurse will complete with the participant a written self management plan. For those randomised to online self management they will be loan an android/iOS tablet computer and be given unique access codes and directed to the online 'How to tutorials .
Visit Two,Three - Telephone Visits There will be 2 telephone visits during the study and will comprise of verbal consent completion of the COPD Assessment Test and adverse event reporting.
Visit Four - End of Study Visit This visit will take place in the participants home and comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique. This will be assessed using the critical errors list for each inhaler devices and technique will be videoed. Participants will also be asked to complete a feedback questionnaire to evaluate user experience. Those allocated online will have their tablet computers collected by the study team and have a written self management plan delivered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Self Management | Other | Behavioral: Written Self management planThe HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. |
| Online Self Management | Active comparator | Behavioral: myCOPDmyCOPD is a system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD. Medication and symptom diaries. Appointment diary, pulmonary rehabilitation videos to promote and support exercises that can be done in the home. Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA. A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects able to complete all study procedures and give written informed consent.
- A diagnosis of COPD defined as per the NICE COPD guidelines
- Male or female volunteers aged 45+ admitted to hospital or the ambulatory care service with a primary diagnosis of acute exacerbation of COPD
- Patients who are taking inhaled therapies for COPD
- Current or ex-smokers with a pack year history of more than 10 years
Key exclusion criteria (3 listed)
- Patients who have any another respiratory disease as their main complaint such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
- Patients unable to read or use an Internet enabled device.
- Patients with any uncontrolled medical condition which in the view of the principle investigator or their team would confound the impact of a COPD directed support tool.
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 system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD. Medication and symptom diaries. Appointment diary Bitesize pulmonary rehabilitation videos designed to promote and support exercises that can be done in a home setting. Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA. A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients. | Behavioural | Online Self Management |
| Written Self management planThe HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. | Behavioural | Written Self Management |
Primary outcome
COPD Assessment Test (CAT)
Time frame: 3 months
This is a validated symptom scoring system used in COPD studies9 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 and 3 months post intervention at visit 4
Inhaler technique
Time frame: 3 months
As different inhaled medication devices require different techniques, each participant's inhaler technique will be assessed according to manufactures guidelines for each device and critical errors recorded. Their technique will be video recorded at visit one and visit two. Any changes to devices during the study will be recorded prior to starting any new treatment. Each participant's technique will be evaluated and the number of critical errors recorded for each device and a composite . Each device will have its own critical error list we have created based on manufactures guidelines. Participants technique will be videoed and assessed using a critical error list for each device by a Health care Professional. This assessment will take place at visit one prior to intervention and 3 months post intervention at visit 4. The difference in the number of errors for each device pre and post intervention will then be recorded.
8 secondary outcomes
St Georges Respiratory Questionnaire (SGRQ)
Time frame: 3 months
modified MRC
Time frame: 3 months
Hospital Anxiety and Depression Score (HAD)
Time frame: 3 months
Patient Activation Measure (PAM)
Time frame: 3 months
Work Productivity Activity Impairment (WPAI)
Time frame: 3 months
Veterans Specific Activity Questionnaire (VSAQ)
Time frame: 3 months
Exacerbation History
Time frame: 3 months
Admission and readmission data
Time frame: 3 months
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 14 Sep 2016.
- Background: PubMed 20075385Rice KL, Dewan N, Bloomfield HE, Grill J, Schult TM, Nelson DB, Kumari S, Thomas M, Geist LJ, Beaner C, Caldwell M, Niewoehner DE. Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):890-6. doi: 10.1164/rccm.200910-1579OC. Epub 2010 Jan 14.
- Background: PubMed 18728206Bourbeau J, Bartlett SJ. Patient adherence in COPD. Thorax. 2008 Sep;63(9):831-8. doi: 10.1136/thx.2007.086041.
- Background: PubMed 19720809Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
- Background: PubMed 1759018Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.
- Background: PubMed 23258783Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
- Results publication: PubMed 12622605Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
- NICE (2010). National guidelines for the management of COPD in adults in primary and secondary care.Link provided by the sponsor.
- Department of Health (2012) An Outcomes Strategy for COPD and Asthma: NHS Companion Document.Link provided by the sponsor.
- Consultation on a strategy for services for chronic obstructive pulmonary disease (COPD) in England.Link provided by the sponsor.
- 4 National Institute for Health and Care Institute (2011) guidance.nice.org.ukLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ben Green, Dr principal investigator
Portsmouth Hospitals NHS Trust
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 and Written Self management plan in people with Chronic Obstructive Pulmonary Diseases, 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 6 inclusion and 3 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 14 Sep 2016. 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 (CAT) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02706600, which also lists 6 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 14 Sep 2016.