Chronic Obstructive Pulmonary Disease (COPD) significantly impacts quality of life. Many patients with COPD have deterioration of symptoms (so-called exacerbations or flare-ups of symptoms), which need additional treatment with medication. In case of a severe exacerbation, a hospitalisation is not uncommon. These exacerbations lead to a increased disease burden, possible permanent damage, and higher healthcare costs. Many patients with COPD also have other chronic diseases such as cardiovascular disease, diabetes mellitus, anxiety and/or depression, which may further increase the disease burden with distressing exacerbations and hospitalisations. We need to improve our understanding of how the symptoms of COPD combined with other chronic diseases manifest themselves in day-to-day life. Such insights will allow doctors and other health professionals to adjust treatment and care, as well as reduce the risk of serious complications.
The purpose of RE-SAMPLE is to identify possible predictors of disease progression and exacerbations of COPD and other chronic diseases through the collection of real-world data (e.g., daily health status). These predictors will be used to offer earlier appropriate personalised treatment for COPD and other chronic diseases.
The RE-SAMPLE study consists of two parts:
- Part 1: Collecting data to determine predictors of disease progression and exacerbations
- Part 2: Digital program with a personalised treatment plan
To understand and meet the needs of the users, RE-SAMPLE will work closely with patients and healthcare professionals during the development of our care services, and in the evaluation of their implementation. We expect that more than 600 patients from the Netherlands, Estonia, and Italy will participate in the RE-SAMPLE study. Of these, 53 patients will also be offered a digital program in the final year (from December 2023). Through this digital program they will obtain a personalised treatment plan based on previously determined predictors and learn, among other things, how to use an action plan for self-treatment of exacerbations of COPD and other chronic disease(s).
RE-SAMPLE participants will be asked to record some data over a period of up to 38 months using a program on their mobile phones, so that we can determine if these are predictors of an exacerbation. Some data need to be recorded daily, such as whether you have more health symptoms than usual (in a digital diary on the mobile phone). Other data only need to be filled in weekly or monthly. Some data will also be filled in automatically (for example, the number of steps taken).
The data collected during the study will be treated confidentially according to (inter)national rules and laws, including the Data Protection Act. The data will be stored in encrypted form. This means that they cannot be traced back to the person directly. The coding is therefore not based on, for example, date of birth, initials or gender. The patient's name will never be mentioned in articles written about the study.
RE-SAMPLE partners include academic institutions, hospitals, non-profit organisations, small and medium-sized enterprises, and information technology companies. Three well-established hospitals offer their sites for the study: (1) Medisch Spectrum Twente, one of the largest hospitals in the Netherlands, with vast experience in conducting research on COPD; (2) Tartu University Hospital, the largest provider of medical care in Estonia and the only university teaching hospital, with its acclaimed Lung Clinic; and (3) Fondazione Policlinico Universitario Agostino Gemelli in Italy, an academic medical centre that has obtained from the Italian Ministry of Health the status of IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), a status granted to Excellency hospitals committed to healthcare and research.