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Clinical Efficacy and Cost Effectiveness of MYCOPD in Patients With Mild and Moderate Newly Diagnosed COPD (EARLY)

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ClinicalTrials.gov Identifier: NCT03620630
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Innovate UK
Imperial College London
Hull and East Yorkshire Hospitals NHS Trust
Hampshire Hospitals NHS Foundation Trust
Central London Community Healthcare NHS Trust
Information provided by (Responsible Party):
my mhealth Ltd

Brief 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. 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.


Condition or disease Intervention/treatment Phase
COPD Device: myCOPD Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled Feasibility study
Masking: Single (Outcomes Assessor)
Masking Description: End of study visit to be completed by a blinded team
Primary Purpose: Health Services Research
Official Title: Evidence Generation for the Clinical Efficacy and Cost Effectiveness of myCOPD in Patients With Mild and Moderate Newly Diagnosed COPD
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
No Intervention: Usual Care
Patients allocated to usual care will continue with their current NHS management in line with national and local guidelines.
Active Comparator: myCOPD
Patients allocated to the myCOPD arm will receive access to a web based application called myCOPD
Device: myCOPD
myCOPD is a multi faceted web based application designed to support people with COPD in the Long term management of their COPD.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability) [ Time Frame: 3 months ]
    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.

  2. Patient Activation Measurement (PAM) [ Time Frame: 3 months ]
    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.

  3. Health Economics Analysis [ Time Frame: 3 months ]
    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

  4. Inhaler Technique [ Time Frame: 3 months ]
    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.

  5. Self Efficacy for Appropriate medication use Scale (SEAMS) [ Time Frame: 3 months ]
    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

  6. Change in Activity [ Time Frame: 7 days post baseline and 7 days prior to end of study visit. ]
    Using FITBIT pedometers 12 patients from each arm will be allocated to activity monitoring to measure daily steps and improvement in total step count.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT03620630


Contacts
Contact: Mal North +441202299583 mal.north@mymhealth.com
Contact: Chloe Barker +441202299583 chloe.barker@mmhealth.com

Locations
United Kingdom
my mhealth Limited Recruiting
Bournemouth, Hampshire, United Kingdom, BH1 1JU
Contact: Mal m North    +44 (0)1202299583    mal.north@mymhealth.com   
Contact: Tom Wilkinson    01202299583    tom.wilkinson@mymhealth.com   
Principal Investigator: Michael Crooks         
Principal Investigator: Kay Roy         
Principal Investigator: William Storrar         
Sponsors and Collaborators
my mhealth Ltd
Innovate UK
Imperial College London
Hull and East Yorkshire Hospitals NHS Trust
Hampshire Hospitals NHS Foundation Trust
Central London Community Healthcare NHS Trust
Investigators
Study Chair: Tom Wilkinson my mhealth Ltd

Publications of Results:
WHO. (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
Mantoani, L. Rubio, N. Mckinstry, B. MacNee, W. Rabinovich, R. (2016) Interventions to modify physical activity in patients with COPD: a systematic review. European Respiratory Journal. [Online] 51(6). Available from: http://erj.ersjournals.com/content/early/2016/04/20/13993003.01744-2015

Other Publications:
Responsible Party: my mhealth Ltd
ClinicalTrials.gov Identifier: NCT03620630     History of Changes
Other Study ID Numbers: MMH/RD/002
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No