Is COPD patient mobility in combination with other parameters a sensitive measure and predictive indicator for early detection of exacerbations in COPD?
An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and monitor the progression of a patient’s COPD.
The clinical study CTC002.1 was initiated November 2012 at the Dpt. for Pulmonary Medicine, Lund University Hospital, with Prof. Leif Bjermer as principal investigator.
Basic findings from the Study CTC002.1 can be concluded as:
Changes in reported symptoms and activity was recorded for a great number of patients. However the limited numbers of exacerbations during the period (three) precluded the possibility of linking observational data to valid prognostic information.
- The overall reports from patients were that they were positive to the system and did not feel that the registration per se had any negative impact on their daily life.
- We were able to link observational data to symptoms reported by the patients and identified individual variability that may be an important platform for future clinical phenotyping. This will though demand a larger patient sample.
- Although the limited number of patients, the study generated a large amount of data linked to different time points. The lessen to learn from this is that data needs to be analysed continuously identifying dynamic trends and not as static quantitative data.
The Study was a joint operativa development project between Boehringer Ingelheim, Lund University, Region Skåne with CareTelCom as main sponsor.
CTC002.1 is a follow up of the study CTC002.1 finalised in September 2013.
CTC002.2 is designed for collections of a broader perspective of parameters that might, or might not have a direct correlation to the disease activity of COPD in the individual patient.
This Study Protocol CTC002.2 involving up to 200 patients, has been approved by the Lund University Ethics Committee. An initial pilot study including 10 patients has been initiated Q3/Q4 2019.
During the course of the Study, mathematical analysis will be applied to data collected. By use of advanced mathematical machine analyses the intention is for gradually finer and more precise indication of changes in patients health status and prediction of increasing probability for exacerbation with COPD patients.
The intention is that at the end of the Study there shall be enough data for verification and CE mark approval of a system able to monitor and indicate changes in health trends as well as to predict increasing probability for a soon upcoming exacerbation.
The study is designed to apply and investigate the value of three main approaches and investigational procedures:
- Development of adaptive and individualized procedures and communicative practises for COPD certified primary care unit’s management and care of COPD patients.
- The verification and contribution of new tools and technology enabling addition of new clinical or health related parameters to follow up and characterize a complex disease.
- Introduction of new less resource demanding data management systems and methodology, and predictive analytical evolutionary mathematical models and techniques to drive quality of life with patients and cost efficiency in health care.
The Protocol initiates an approach to evaluate and use methodology, systems and techniques to expand our knowledge and understanding of drivers for COPD and in what way we possibly could intervene and change the course of the disease early in the process.