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

NCT04955080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 216

Last updated 2025-12-10

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Twente

    collaborator OTHER

  • University of Piraeus

    collaborator UNKNOWN

  • Tartu Ülikooli Kliinikum

    collaborator UNKNOWN

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • Federation Europeenne des Hopitaux et des Soinds de Sante

    collaborator UNKNOWN

  • Deutsches Forschungszentrum fur Kunstliche Intelligenz GMBH

    collaborator UNKNOWN

  • Atos IT Solutions and Services Iberia

    collaborator UNKNOWN

  • Roessingh Research and Development

    collaborator OTHER

  • Innovation Sprint

    collaborator UNKNOWN

  • Medisch Spectrum Twente

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2025-09-01
Completion
2025-09-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955080 on ClinicalTrials.gov