Real-time data monitoring for personalized care in pulmonary disease

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

This study is testing how using a mobile app to track daily symptoms can help understand and improve care for people with COPD and other complex health issues.

Quick facts

• Study type: Observational
• Enrollment: 710 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Medisch Spectrum Twente (Academic / other)
• Locations: 1 site (Enschede)
• Trial ID: NCT04955080 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to identify key predictors of disease progression in patients with Chronic Obstructive Pulmonary Disease (COPD) and complex chronic conditions using real-world data collected through a mobile application. Participants will be monitored over a maximum of 38 months, with data collected at baseline, daily symptom diaries, follow-up visits, and during hospitalizations. The study also evaluates the feasibility of collecting real-world data from the patient's perspective, ensuring that the parameters and measurement tools are updated regularly to reflect the most relevant information.

Who should consider this trial

Good fit: Ideal candidates include individuals over 40 years old with a clinical diagnosis of COPD and at least one comorbidity, who are either stable or experiencing exacerbations.

Not a fit: Patients without a diagnosis of COPD or those under 40 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance personalized treatment strategies for patients with COPD and related comorbidities.

How similar studies have performed: Other studies utilizing real-world data for chronic disease management have shown promise, indicating potential for success in this approach.

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)

Where this trial is running

Enschede

• Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)

Conditions Pulmonary Disease, Chronic Obstructive; Exacerbation Copd; Comorbidities and Coexisting Conditions