Trial Overview

Trial Team

Information for Participants

Trial Overview

Trial Team

Information for Participants

Title

A randomised controlled study to explore the safety and efficacy of the mySmartCOPD treatment re-alignment algorithm as part of a digital self-management app in patients with COPD.

Description

Although COPD cannot be cured, optimal management provides symptom control, slows progression of the disease, and may improve the quality of life. Management of COPD becomes suboptimal when physicians fail to prescribe appropriate inhaled therapies, due to poor adherence to evidence-based guidelines and underdiagnosis, or when patients fail to adhere to prescribed treatment regimens.

my mhealth have developed an algorithm (mySmartCOPD) to assist patients with understanding their level of symptom burden according to CAT result and their exacerbation risk. The algorithm then analyses current patient prescribed inhaled medication against those recommended by the GOLD 2023 report and informs the patient via the app as to whether their medication needs to be changed by their healthcare provider. This trial will explore whether the introduction of the mySmartCOPD algorithm to the myCOPD app can be used as a safe, effective and acceptable tool to assist patients to achieve optimal, guideline based inhaled therapy and therefore provide greater symptom control and lowered exacerbation risk for COPD patients using the app. Participants will be randomised to the myCOPD app (control), or to the myCOPD app with the additional mySmartCOPD algorithm (intervention).

This study is an open-label randomised control trial with inbuilt pilot phase qualitative sub-study:

Phase 1 (pilot – 50 participants): Interim futility analysis on adherence to intervention advice
Phase 2 (efficacy – 746 participants (including pilot phase participants): Safety, acceptability and efficacy of intervention
Qualitative Sub-study: Acceptability of the intervention (15-20 intervention participants)

Objectives

Primary:

To determine the safety, acceptability and efficacy of a digital treatment guidance algorithm for inhaled treatment in patients with COPD. The intention is to measure the impact of the app in prompting patients to achieve optimal management.

Secondary:

To assess effect of the intervention on patients’ symptom control, including exacerbation frequency and patient wellness scores.
To understand the feasibility of the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase in order to maximise healthcare equality
To assess the levels of app usage and engagement
To assess patients’ experience of using the intervention

Trial Status

In set-up

Population

Patients diagnosed with COPD who use the myCOPD app through a prescription from their healthcare provider.

Funder

NIHR logo

NIHR AI_AWARD02200

Senior Trial Manager

Wendy O’Brien

Trial Manager

Sinead Helyar

Data Manager

Rob Waugh

Contact Information for trial queries

Email: [email protected]

Phone: 02380 599194

SAE Reporting

Email: [email protected]

Phone: 0844 7740621

mysmartcopd logo

Exploring the safety and effects of the mySmartCOPD system for COPD patients

Welcome to the mySmartCOPD study Information for Participants page where you can read about the mySmartCOPD study.

The mySmartCOPD study will recruit patients who are already registered and use the myCOPD app. You can be registered to use the myCOPD app only by prescription by your healthcare provider.

If you are a current user of the myCOPD app and would like to register your interest in the mySmartCOPD study, please read the below Patient Information Sheet:

Patient Information Sheet

To register your interest, or if you would like to speak to a member of the study team, please call us on 02380 599194 or email [email protected] .

Background and study aims

Chronic Obstructive Pulmonary Disease (COPD) is a common, globally important condition that affects the lives of millions of patients worldwide. It is caused by lung damage from smoking and other harmful substances in the air. This damage worsens over time and leads to problems such as coughing, wheezing and fatigue, which can affect the quality of life, the ability to exercise and the overall health of people with COPD.

COPD cannot be cured, but it can be managed. This means that with the right medication, people with COPD can control their symptoms and slow down the progression of the disease. This is why it is important for doctors to regularly review patients’ symptoms and prescribe the most appropriate medication to improve patients’ quality of life.

We want to investigate a new COPD medication management system, called mySmartCOPD, to see how it can help doctors prescribe the best available medication for patients and how this can improve the lives of people with COPD. mySmartCOPD is an addition to the existing COPD management app, myCOPD.

Who can take part?

We are looking for COPD patients who are registered on the myCOPD app. The mySmartCOPD system is an addition to this app.

To learn more about the current myCOPD app without the mySmartCOPD system, please visit the my mhealth application website .

What does the study involve?

If you take part, you will be randomly put into one of two groups. One group will use the myCOPD app with the mySmartCOPD system added, and the other group will continue to use the myCOPD app as usual.

You will be asked to enter your daily COPD symptom scores, update your medication if it changes and fill out some monthly questionnaires to measure how you are feeling.

The mySmartCOPD system will check the data you enter and alert you if your medication is not the best for managing your symptoms. You can also get support to arrange a medication review appointment with your healthcare professional and discuss whether you should change your medication.

You may be asked to share your feedback on using the system after the study, so the team can improve it for future users.

What are the possible benefits and risks of participating?

Benefits may include an improvement in your COPD symptoms or a reduction in unnecessary side effects by being on the correct medication for you. Your participation will also help us understand how to better treat COPD patients in the future. Risks may include effects associated with changing medication and the need to fill out study questionnaires which you would not normally do if you were not on the study.

I would like to register my interest in the study. What do I do next?

If you are already a user of the myCOPD app and are interested in the study, please read the Patient Information Sheet:

Patient Information Sheet

To register your interest in the study, or if you would like to speak to a member of the study team, please call us on 02380 599194 or email [email protected] .