Pulmonary Disease, Chronic ObstructiveRE-SAMPLENCT04955080
REal-time Data Monitoring for Shared Adaptive, Multi-domain and Personalised Prediction and Decision Making for Long-term Pulmonary Care Ecosystems (RE-SAMPLE)
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation Copd, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Exacerbation Copd, Comorbidities and Coexisting Conditions
- How many people
- 216 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2.5 years.
Secondary outcomes (2)
Feasibility of the RWD collection.
This relates to the usability of the application for data collection. The system usability scale will be used as a benchmarking tool that measures the level of usability.
Measured: Through study completion, an average of 1 year.
Feasibility of the RWD collection.
Assessment of the user experience associated with the data collection. The User Experience Questionnaire will be used to assess the user experience and as a benchmark. Furthermore, patients will be given the opportunity to articulate also in their own words how they experience the RWD collection.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start24 Jan 2022
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, University of Piraeus, Tartu Ülikooli Kliinikum, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Federation Europeenne des Hopitaux et des Soinds de Sante, Deutsches Forschungszentrum fur Kunstliche Intelligenz GMBH, Atos IT Solutions and Services Iberia, Roessingh Research and Development, Innovation Sprint
- Responsible party
- Principal investigator, Job van der Palen, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955080
- Sponsor's protocol ID
- Grant Agreement No 965315
- Acronym
- RE-SAMPLE
- Status last verified
- May 2025
- First submitted
- 17 Jun 2021
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-time Data Monitoring for Shared Adaptive, Multi-domain and Personalised Prediction and Decision Making for Long-term Pulmonary Care Ecosystems (RE-SAMPLE)
- ClinicalTrials.gov ID
- NCT04955080
- Acronym / sponsor ID
- RE-SAMPLE / Grant Agreement No 965315
- Conditions
- Pulmonary Disease, Chronic Obstructive, Exacerbation Copd, Comorbidities and Coexisting Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- University of Twente, University of Piraeus, Tartu Ülikooli Kliinikum, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Federation Europeenne des Hopitaux et des Soinds de Sante, Deutsches Forschungszentrum fur Kunstliche Intelligenz GMBH, Atos IT Solutions and Services Iberia, Roessingh Research and Development, Innovation Sprint
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictors for exacerbations of COPD and comorbidities
Time frame: Through study completion, an average of 2.5 years.
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.
2 secondary outcomes
Feasibility of the RWD collection.
Time frame: Through study completion, an average of 1 year.
Feasibility of the RWD collection.
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation Copd, run by Medisch Spectrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors for exacerbations of COPD and comorbidities (time frame: Through study completion, an average of 2.5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.