Chronic Obstructive Pulmonary Disease (COPD) is one of the most prevalent chronic diseases, affecting 10% of people over the age of 50. The most common symptoms of COPD are breathlessness (shortness of breath), excessive sputum production, and a chronic cough. According to the World Health Organisation, 64 million people are affected worldwide and about 3 million died from the disease. Furthermore, WHO predicts it will become the third leading cause of death worldwide by 2030.
Patients with COPD often reduce their physical activity and their normal way of life because of unpleasant symptoms associated with the disease. Even though a lack of physical activity is one of the most common predictors of mortality, before PROactive there were no valid tests to measure the impact of the disease on physical activity levels and related dimensions (e.g. the symptoms experienced during physical activity). The commonly used lung function tests for COPD provide only limited information on the progression of the disease and the patients’ quality of life. Exercise tests, on the other hand are more an assessment of the capacity of the patient, rather than of the problems patients experience in their daily lives.
An innovative tool which simplifies the lives of patients
By following guidelines outlined by the regulatory authorities, the PROactive project developed innovative patient reported outcome (PRO) tools to measure patients’ experience of physical activity in terms of ‘amount’ of activity and ‘difficulty’. They did this in an innovative way by merging questions about patients’ experience of physical activity with information obtained through wearable physical activity monitors. This is not only an innovation but also a simplification in the PRO field which makes the life of patients easier: they have to answer only a few relevant questions and the rest is recorded via activity monitors sensitive enough to capture the activity of COPD patients. Moreover, the questionnaires were developed by patients and are therefore written in the language of patients, making them easy to use and understand.
In order to ensure the robustness of the new PRO tools, the consortium tested them in a heterogeneous group of more than 1000 patients in five EU languages. All the data gathered has been submitted to the European Medicines Agency for the qualification procedure of novel drug development methodologies. If accepted by the regulators, these new PRO tools would enable pharmaceutical companies and others to use them in clinical trials to assess the effectiveness of new treatments on physical activity. Such therapies could be drugs, but also non-pharmacological interventions such as rehabilitation.
In the meantime, the tool is already being used for research purposes by partners in the project, and at least one company outside of the consortium. Furthermore, more than 50 culturally sensitive translations are already available for use in global research.
Putting physical activity higher on the agenda
While the development of the PRO tools is the most significant project achievement, the project also contributed to the field in other ways.
- It helped clarify the role that physical inactivity plays in COPD and put it higher on the agenda of patient organisations, researchers and clinicians. Patients are already experiencing benefits, as clinicians are increasingly recognising that tackling physical inactivity should be one of the key targets in the management of this disease.
- While some activity monitors are valid tools to get insight in the amount of physical activity patients engage in, this project has shown that they are not enough to capture the physical activity experience of patients suffering from COPD. They need to be combined with questions providing further insight into how patients experience physical activity.
- The project developed a methodology for evaluating activity monitors to identify those sensitive enough to measure physical activity in patients with a chronic disease such as COPD. Three such monitors were identified and two of these extensively used. Furthermore, the project developed the know-how on processing, standardising and analysing data from activity monitors, so this data can be successfully used in clinical trials.
- It developed several new, innovative interventions for COPD patients, such as a tele-coaching method to boost patients’ activity levels. A short term multi-centre study showed that this tele-coaching intervention significantly increases the level of physical activity in COPD patients, opening up pathways for further research.
For the benefit of industry, academia and patients
PROactive’s new tools will provide drug companies with new ways of assessing the clinical benefits of novel treatments on the physical activity in COPD patients. The tools will also benefit patients by helping them evaluate the improvements or deterioration in their physical activity experience, including the effect of new treatments on this important aspect of their lives. Finally, participation in PROactive enabled academic researchers to master scientific rigour needed to develop such PRO tools, raising their profile in the field and helping them build a valuable network for future research.
What happens next?
Even though the project has officially ended, the project participants signed a memorandum of understanding to stay together and continue to develop their tools. The idea is to oversee future uses of the tools, such as translations to other languages and the development of the tools in other chronic disease areas.