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

NCT04955080 | Completed

• 1 other identifier: Grant Agreement No 965315
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this RE-SAMPLE cohort study is to identify from a real-world data (RWD) set that will be collected, a subset of data that can be potentially used as important predictors and parameters for disease progression of COPD and complex chronic conditions, and multi-morbid exacerbations. The secondary objective is to evaluate the feasibility of RWD collection from a patient's perspective. Study design: This is a prospective observational cohort study to collect RWD in patients with COPD and complex chronic conditions, with a maximum of 38 months of follow-up. Measurements are performed and RWD are collected by using the Healthentia mobile phone application at baseline (e.g. patient characteristics), daily (e.g. symptom diary), during follow-up visits and at deterioration, and from hospital data (e.g. healthcare visits). The choice of parameters and measurement tools that will be collected during the cohort will be updated every three months during the first year of the cohort (via protocol amendments). These updates are based on citizen-design sessions and on new literature insights. Prognostic models will be developed including predictors derived from the RWD collection.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Predictors for exacerbations of COPD and comorbidities

  Prognostic performance of the validated predictive model for COPD and comorbid exacerbations and disease progression from RWD. The measures for progression will be survival, based on all-cause mortality, as well as morbidity. Morbidity is defined as time until first hospitalisation for an acute exacerbation of COPD and CCC, time until first moderate COPD exacerbation, time until first pneumonia, and total number of COPD and CCC exacerbations (extracted from daily symptom diaries) and pneumonia.

  Through study completion, an average of 2.5 years.

Secondary Outcomes (2)

• Feasibility of the RWD collection.

  Through study completion, an average of 1 year.

• Feasibility of the RWD collection.

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to enroll 710 patients with both COPD and complex chronic conditions over 28 months (July 2021 until October 2023). Patients will be followed-up for a 38-month period (July 2021 until August 2024). These patients will be recruited from one of the three pilot sites (n=263 from Medisch Spectrum Twente, Netherlands); n=263 from Policlinico Universitario Fondazione Agostino Gemelli, Italy; n=184 from Tartu Ülikooli Kliinikum, Estonia.

You may qualify if:

• 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:
• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medisch Spectrum Twente: lead
• University of Twente: collaborator
• University of Piraeus: collaborator
• Tartu Ülikooli Kliinikum: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Federation Europeenne des Hopitaux et des Soinds de Sante: collaborator
• Deutsches Forschungszentrum fur Kunstliche Intelligenz GMBH: collaborator
• Atos IT Solutions and Services Iberia: collaborator
• Roessingh Research and Development: collaborator
• Innovation Sprint: collaborator

Study Sites (1)

Medisch Spectrum Twente

Enschede, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 8, 2021
• Study Start: January 24, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-05

Locations

NL (1)