NCT03620630: EARLY

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

Completed NA Last updated 28 February 2020

What this trial tests

NA trial testing myCOPD in COPD in 60 participants. Completed in 3 December 2019.

Timeline

9 November 2018

Primary endpoint
30 September 2019

3 December 2019

Quick facts

Lead sponsor	my mhealth Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	60
Start date	9 November 2018
Primary completion	30 September 2019
Estimated completion	3 December 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• myCOPD

Conditions studied

• COPD — all drugs for COPD →

Sponsor

my mhealth Ltd

Who can join

Adults 40 to 80, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD).
   Burge AT, Cox NS, Abramson MJ, Holland AE. · · 2020 · cited 87× · PMID 32297320 · DOI 10.1002/14651858.cd012626.pub2
2. Digital interventions for the management of chronic obstructive pulmonary disease.
   Janjua S, Banchoff E, Threapleton CJ, Prigmore S, et al · · 2021 · cited 55× · PMID 33871065 · DOI 10.1002/14651858.cd013246.pub2
3. Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial.
   Crooks MG, Elkes J, Storrar W, Roy K, et al · · 2020 · cited 35× · PMID 33263052 · DOI 10.1183/23120541.00460-2020
4. The COPD Pipeline XXXX.
   Gross N. · · 2019 · cited 1× · PMID 30775429 · DOI 10.15326/jcopdf.6.1.2018.0165