TLM_COPD: Usefulness and Efficacy of Telemonitoring of Patients With COPD

Sponsor

University of Monastir (Other)

Overall Status

Recruiting

CT.gov ID

NCT06135025

Collaborator

(none)

164

Enrollment

Location

Arms

Anticipated Duration (Months)

40.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Other: Telemonitoring	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Masking:

Single (Outcomes Assessor)

Masking Description:

the outcome assessor was blinded to allocation.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Exacerbation rate [30 days after inclusion]
rate of COPD exacerbation
Need for hospitalization for AECOP [30 days after inclusion]
rate of hospitalization for AECOP
Mortality [30 days after inclusion]
rate of Death from any cause

Secondary Outcome Measures

EFI [30 days after inclusion]
time with free interval from exacerbation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Khaoula Bel Haj Ali	Monastir		Tunisia	5020

Sponsors and Collaborators

University of Monastir

Investigators

Study Director: Khaoula Bel Haj Ali, MD, CHU Fattouma Bourguiba Monastir, service des urgences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pr. Semir Nouira, professor, University of Monastir

ClinicalTrials.gov Identifier:

NCT06135025

Other Study ID Numbers:

TLM_COPD

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pr. Semir Nouira, professor, University of Monastir

Study Results

No Results Posted as of Nov 18, 2023