Usefulness and Efficacy of Telemonitoring of Patients With COPD

NCT ID: NCT06135025

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-12-01

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

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Telemonitoring

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaoula Bel Haj Ali, MD

Role: STUDY_DIRECTOR

CHU Fattouma Bourguiba Monastir, service des urgences

Locations

Khaoula Bel Haj Ali

Monastir, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Khaoula Bel Haj Ali, MD

Role: CONTACT

belhajalikhaoula@yahoo.fr

73106000

Facility Contacts

Khaoula Bel Haj Ali

Role: primary

belhajalikhaoula@yahoo.fr

73106000

Other Identifiers

TLM_COPD

Identifier Type: -

Identifier Source: org_study_id