Clinical trial NCT06135025: Usefulness and Efficacy of Telemonitoring of Patients With COPD
Official title: Evaluation of the Usefulness and Efficacy of Telemonitoring of Patients With COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Keywords: exacerbation
hospitalization
telemonitoring
acute
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial. Potentially eligible participants are identified using available records from the emergency department of Fattouma Bourguiba Monastir Hospital.
Primary purpose: SUPPORTIVE_CARE

Brief summary: A substantial number of people with COPD suffer from exacerbations, which are defined as an acute worsening of respiratory symptoms. To minimize exacerbations, telehealth has emerged as an alternative to improve clinical management, access to health care, and support for self-management. The study objective was to map the evidence of telehealth/telemedicine for the monitoring of adult COPD patients after hospitalization due to an exacerbation.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a major public health problem due to its high prevalence along with high morbi-mortality. Indeed, it is the third leading cause of all-cause death worldwide. COPD is marked by the onset of acute exacerbations (AECOP), which accelerate the progression of the disease, the decline in respiratory function resulting in poor quality of life with a worse survival. Therapeutic education of patients concerning treatment compliance and avoidance of exacerbating factors is one of the means of preventing AECOPD. Education sessions usually occur during during consultations and hospitalizations. Face-to-face visits with health professionals can be hindered by severity of COPD, geographic distance and limited access to health care services.

Telemonitoring patients with COPD could improve delivery of health care, reduce exacerbations, improve quality of life, and results in lower rates of hospitalisation. However, it is unclear whether providing telehealth care improves outcomes of patients with COPD.

This trial aimed to assess the usefulness and efficay of telemonitoring patients with AECOP

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years old with prior diagnosis of COPD according to GOLD criteria

Exclusion Criteria:

* dementia
* pregnancy
* reluctance or self-declared inability to engage in the study
* simultaneous participation in another trial involving a therapeutic or non-therapeutic intervention that will interfere with the primary and secondary endpoints of this study.

Primary outcomes:
measure: Exacerbation rate
timeFrame: 30 days after inclusion
measure: Need for hospitalization for AECOP
timeFrame: 30 days after inclusion
measure: Mortality
timeFrame: 30 days after inclusion
Secondary outcomes:
measure: EFI
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Khaoula Bel Haj Ali
Study officials:
affiliation: CHU Fattouma Bourguiba Monastir, service des urgences
name: Khaoula Bel Haj Ali, MD
role: STUDY_DIRECTOR
References: