Usefulness and Efficacy of Telemonitoring of Patients With COPD

COPD Clinical Trial

— TLM_COPD  

Official title:

Evaluation of the Usefulness and Efficacy of Telemonitoring of Patients With COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135025
• Other study ID #: TLM_COPD
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2023
• Source: University of Monastir
• Contact: Khaoula Bel Haj Ali, MD
• Phone: 73106000
• Email: belhajalikhaoula[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Telemonitoring
the patients included receive a weekly phone call from the participating physician to to support self-management improvement, use of inhalation devices, rehabilitation, monitoring of signs/symptoms by treatment management, counseling, motivation, and prevention of exacerbations, early recognition of exacerbation signs and planify access to health care facility. at 1 month a Face to Face visit is planned to collect data.

Locations

Country	Name	City	State
Tunisia	Khaoula Bel Haj Ali	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbation rate	rate of COPD exacerbation	30 days after inclusion
Primary	Need for hospitalization for AECOP	rate of hospitalization for AECOP	30 days after inclusion
Primary	Mortality	rate of Death from any cause	30 days after inclusion
Secondary	EFI	time with free interval from exacerbation	30 days after inclusion