Usefulness and Efficacy of Telemonitoring of Patients With COPD

NCT06135025 | Unknown DMC

• 1 other identifier: TLM_COPD
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

exacerbation; hospitalization; telemonitoring; acute

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• EFI

  30 days after inclusion

Study Arms (2)

TLM_group

ACTIVE COMPARATOR

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

STD_group

NO INTERVENTION

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.

Interventions

Telemonitoring 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.

TLM_group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Khaoula Bel Haj Ali

Monastir, 5020, Tunisia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Khaoula Bel Haj Ali, MD

  CHU Fattouma Bourguiba Monastir, service des urgences

  STUDY DIRECTOR

Central Study Contacts

Khaoula Bel Haj Ali, MD

CONTACT

73106000; belhajalikhaoula@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcome assessor was blinded to allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: This is a randomized controlled trial. Potentially eligible participants are identified using available records from the emergency department of Fattouma Bourguiba Monastir Hospital.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: November 18, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

TU (1)