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

NCT03620630 | Completed DMC

• 1 other identifier: MMH/RD/002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (6)

• Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability)

  3 months

• Patient Activation Measurement (PAM)

  3 months

• Health Economics Analysis

  3 months

• Inhaler Technique

  3 months

• Self Efficacy for Appropriate medication use Scale (SEAMS)

  3 months

Study Arms (2)

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

Device: myCOPD

Interventions

myCOPD DEVICE

myCOPD is a multi faceted web based application designed to support people with COPD in the Long term management of their COPD.

myCOPD

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• my mhealth Ltd: lead
• Innovate UK: collaborator
• Imperial College London: collaborator
• Hull University Teaching Hospitals NHS Trust: collaborator
• Hampshire Hospitals NHS Foundation Trust: collaborator
• Central London Community Healthcare NHS Trust: collaborator

Study Sites (1)

my mhealth Limited

Bournemouth, Hampshire, BH1 1JU, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 27176208 BACKGROUND

• Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.

  PMID: 18046898 BACKGROUND

• Lee 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.

  PMID: 28602061 BACKGROUND

• 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/

  RESULT

• 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

  RESULT

• 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.

  PMID: 26508848 RESULT

• Thabane 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.

  PMID: 23074432 RESULT

• Arbillaga-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.

  PMID: 28250201 RESULT

• Waschki 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.

  PMID: 21273294 RESULT

• Mantoani 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.

  PMID: 27103381 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tom Wilkinson

  my mhealth Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: End of study visit to be completed by a blinded team
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised controlled Feasibility study

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 8, 2018
• Study Start: November 9, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 3, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)