Usefulness and Efficacy of Telemonitoring of Patients With COPD (TLM_COPD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Other: Telemonitoring

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

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khaoula Bel Haj Ali, MD; Phone Number: 73106000; Email: belhajalikhaoula@yahoo.fr

Study Locations

• Tunisia
  • Monastir, Tunisia, 5020
    • Recruiting
    • Khaoula Bel Haj Ali
    • Contact: Khaoula Bel Haj Ali; Phone Number: 73106000; Email: belhajalikhaoula@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TLM_group; 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 at the pneumology clinic which also unifies the criteria for monitoring and treatment of respiratory disease. Whenever patients came to the emergency room (ER), they were evaluated by the Pneumologist in charge, ergo maintaining a similar approach in the assessment of ERs and deciding whether the patient should be admitted or discharged, independently of their group assignment.	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.
No Intervention: STD_group; Patients in this group receive usual monitoring and treatment regimen is left to the discretion of the treating physicians. At inclusion, patients receive a phone call to collect data.at 1 month a Face to Face visit is planned at the pneumology clinic which also unifies the criteria for monitoring and treatment of respiratory disease. Whenever patients came to the emergency room (ER), they were evaluated by the Pneumologist in charge, ergo maintaining a similar approach in the assessment of ERs and deciding whether the patient should be admitted or discharged, independently of their group assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation rate	rate of COPD exacerbation	30 days after inclusion
Need for hospitalization for AECOP	rate of hospitalization for AECOP	30 days after inclusion
Mortality	rate of Death from any cause	30 days after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFI	time with free interval from exacerbation	30 days after inclusion

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Study Director: Khaoula Bel Haj Ali, MD, CHU Fattouma Bourguiba Monastir, service des urgences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: November 11, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: acute; exacerbation; hospitalization; telemonitoring
• Other Study ID Numbers: TLM_COPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No