Objectives: The main objective of this RE-SAMPLE cohort study is to identify from a RWD data 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 CCCs,…
ID
Source
Brief title
Condition
- Heart failures
- Glucose metabolism disorders (incl diabetes mellitus)
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the prognostic performance of the validated
predictive model for COPD and CCC progression and exacerbations 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.
Secondary outcome
The secondary study outcome is the feasibility of the RWD collection. This
relates to the usability of the application for data collection, and the user
experience associated with the data collection. The system usability scale will
be used as a benchmarking tool that measures the level of usability. 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.
Background summary
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a common progressive
lung condition with distressing exacerbations. Many patients with COPD have
multiple complex chronic conditions (CCCs) such as cardiovascular diseases,
that increase the patient burden, mortality, healthcare consumption and costs.
These multi-morbidities in COPD can trigger exacerbations, share common risk
factors, and have overlapping symptoms and pathophysiology. The complexity of
CCCs requires in-depth understanding of the interplay of not only individual
clinical CCC characteristics, but also the patient*s capabilities, functional
limitations, preferences and behaviour. Real World Data (RWD) from daily life
in combination with data from clinical studies will boost the output on
predictions and patterns of exacerbations and impact disease management by
generalising results from clinical research to routine clinical practice.
Benefits of RWD integration in disease management are expected to arise from
earlier initiation of appropriate treatment resulting in less severe
complications, accelerated recovery, and reduced healthcare utilisation, with a
focus of care in daily life instead of the hospital.
Study objective
Objectives: The main objective of this RE-SAMPLE cohort study is to identify
from a RWD data 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 CCCs, and multi-morbid exacerbations. The secondary objective is to
evaluate the feasibility of RWD collection from a patient*s perspective.
Study design
Study design: This is a prospective observational cohort study to collect RWD
in patients with COPD and CCCs, 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 burden and risks
The risk for adverse events due to participation in this study is negligible as
medical treatment of the patients will be continued and they will receive
regular usual care during the study.
Koningstraat 1
Enschede 7512 KZ
NL
Koningstraat 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
Clinical diagnosis of COPD according to the GOLD criteria (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, chronic heart failure, ischaemic
heart disease, active symptoms of anxiety and/or depression (>=11 HADS and/or
active treatment for anxiety/depression at inclusion), paroxysmal atrial
fibrillation, obstructive sleep apnoea syndrome (OSAS) OR at least two risk
factors for developing comorbidities (max. 25% of the population): active
smokers, high BMI, low BMI, atrial hypertension, hypercholesterolemia, kidney
failure which requires dialysis;
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;
Written informed consent from the subject prior to participation;
Furthermore, a maximum of 25% of the population with COPD GOLD class I (FEV1 >
80% of the predicted value and FEV1/FVC < 0.70) can be included, if these
patients are active smokers and have at least one comorbidity as mentioned
above.
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
Low chance for survival: patients who started a palliative care programme,
patients with active malignancies for which chemotherapy and/or radio therapy
is currently prescribed, low survival probability, based on physician
assessment;
Presence of the following other active lung disease: asthma, lung cancer,
tuberculosis, interstitial lung disease with the exception of fibrosis due to
COPD;
Severe psychiatric illness, diagnosed by anamnesis;
Patients with cognitive impairment (Mini Mental State Examination (MMSE) < 24)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04955080 |
| CCMO | NL77763.100.21 |