Actimetry Protocol in COPD Patients

Recruiting

• Conditions: COPD; Inactivity, Physical

• Registration Number: NCT05918003
• Lead Sponsor: Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

Brief Summary

Recently, the principal investigator published an EI predictive Machine Learning algorithm based solely on clinical data, without any physical activity measures, collected from 1 409 patients. The GOLD standard of EI was defined on the basis of interrogation criteria. Patients considered as EI reported walking less than 10 minutes per day on average, and the pulmonologist judged that the patient had mainly "domestic activities".

Despite the subjective nature of the GOLD standard, the algorithm validated on a test sample had an error rate of only 13.7% (AUROC: 0.84, CI95% \[0.75-0.92\]). In the total study population (n=1409), 34% of patients were ultimately classified as EIs by the algorithm, in agreement with the results of studies using actimetry as the GOLD standard.

The principal investigator now wish to verify and improve the validity of the MLA on a new smaller population of 104 patients, using a physiological GOLD standard such as three-dimensional actimetry.

Detailed Description

It has been shown that COPD patients have a significantly decreased daily physical activity (DPA) compared to matched subjects. Moreover, the severity of inactivity is correlated with several prognostic indices such as the frequency of exacerbations, quality of life and mortality. These findings lead to the recommendation, with a level of evidence A, of DPA in the context of medically supervised respiratory rehabilitation programs and/or by encouraging patients to participate in programs promoting physical activity.

However, despite the established benefits, it is estimated that this rehabilitative management actually involves only 10% of the patients who should benefit from it. Among the various causes of this situation, the underestimation of excessive inactivity (EI) by pulmonologists is one of the causes of this care deficit.

Currently, only actimetry can accurately assess the patient's level of physical activity.

To alert pulmonologists to this excessive situation justifying priority care, without resorting to actimetry, the aCCPP developed a Machine Learning Algorithm (MLA) based on clinical data from the Colibri-BPCO digital consultation that predicts excessive inactivity.

In this study, the GOLD standard EI was defined using clinical criteria summarized below. EI patients reported walking for an average of less than 10 minutes per day, and the pulmonologist judged on questioning that the DPA was indeed essentially "domestic." The objective of the MLA was to correctly classify EI subjects versus obviously active subjects hereafter referred to as Overtly Active (OA).

The MLA was validated on a test sample with an error rate of 13.7% (AUROC: 0.84, IC95% \[0.75- 0.92\]). In the total population studied (n=1409), 34% of patients were finally classified as EIs, in line with the results of studies using actimetry as the GOLD standard.

Following the publication of this work , the principal investigator would like to verify the validity of the algorithm on a new population using the recognized GOLD standard: three-dimensional actimetry measurements.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Any patient with a diagnosis of COPD, all GOLD stages combined, who receives a properly informed Colibri-COPD digital consultation.

Exclusion Criteria

• Patients with other unstable conditions with treatment,

• Unstable patients:

  • Who had an exacerbation in the previous 2 months,
  • Patients who have had surgery, a heart attack, a fall, or an accident limiting usual movements in the previous 3 months.

• Protected patients within the meaning of the French Public Health Code

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC-ROC as the primary endpoint to judge the performance of the algorithm	December 2023	A contingency table recording the algorithm's performance metrics will be constructed in parallel from the actimetry data. The AUC-ROC will be used as the primary endpoint to judge the performance of the algorithm.

Trial Locations

Locations (1)

Private Practice; 🇫🇷 Grenoble, France