REal-time Data Monitoring for Shared Adaptive, Multi-domain and Personalised Prediction and Decision Making for Long-term Pulmonary Care Ecosystems (RE-SAMPLE)

Launched by MEDISCH SPECTRUM TWENTE · Jun 28, 2021

Keywords

ClinConnect Summary

The RE-SAMPLE trial is studying how real-time data collected from patients with chronic obstructive pulmonary disease (COPD) and other related health issues can help predict the progression of their condition and improve long-term care. Researchers want to find out which pieces of information—like daily symptoms and medical history—are most useful for understanding and managing COPD. They will collect this information using a mobile app over a period of up to 38 months. The trial also aims to see how easy or challenging it is for patients to share their data.

To join the study, participants need to be at least 40 years old and have a clinical diagnosis of COPD, along with at least one other health issue, such as diabetes or heart disease. They should have had some recent worsening of their breathing problems, like needing medication or hospitalization. Participants will be asked to fill out daily symptom diaries and attend follow-up visits, allowing researchers to gather valuable insights about their health over time. It's important to note that patients must be able to read and write in the language of the pilot site and have access to the internet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of COPD according to the GOLD criteria \[5\] (FEV1 \< 80% of the predicted value and FEV1/FVC \< 0.70);
• • Patients can be included both at stable state and during exacerbation/hospitalization;
• * At least one comorbidity:
• • diabetes mellitus (glucocorticoid-induced, or stable type 1 or 2), chronic heart failure (clinical diagnosis according to the ESC guidelines), ischaemic heart disease (history of myocardial infarction, angina pectoris), active symptoms of anxiety and/or depression (≥11 Hospital Anxiety and Depression Scale , and/or anxiety or depression symptoms being treated at the time of inclusion);
• • Under treatment at one of the pilot sites (MST, TUK, GEM);
• • \>40 years of age;
• • Smoker or ex-smoker;
• • Able to understand, read and write the language spoken in the country of the pilot site.
• • Accessibility to internet;
• • Written informed consent from the subject prior to participation.
• • Furthermore, 25% of the patients should also have ≥ 2 exacerbations, defined as respiratory problems that required a course of oral corticosteroids / antibiotics in the two years preceding study entry; and/or ≥ 1 hospitalisation for respiratory problems in the two years preceding study entry; and/or modified MRC (mMRC) score of 3 or 4 (COPD patients with these scores have a higher chance of exacerbating).
• Exclusion Criteria:
• • Serious other diseases with a low survival rate;
• • Presence of any other active lung disease (e.g., sarcoidosis);
• • Severe psychiatric illness, diagnosed by anamnesis;
• • Maintenance therapy with antibiotics
• • Patients with cognitive impairment (Mini Mental State Examination (MMSE) \< 24)