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Usefulness and Efficacy of Telemonitoring of Patients With COPD

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06135025
Acronym
TLM_COPD
Enrollment
164
Registered
2023-11-18
Start date
2023-08-01
Completion date
2023-12-01
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

exacerbation, hospitalization, telemonitoring, acute

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

Interventions

OTHERTelemonitoring

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.

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

the outcome assessor was blinded to allocation.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Exacerbation rate30 days after inclusionrate of COPD exacerbation
Need for hospitalization for AECOP30 days after inclusionrate of hospitalization for AECOP
Mortality30 days after inclusionrate of Death from any cause

Secondary

MeasureTime frameDescription
EFI30 days after inclusiontime with free interval from exacerbation

Countries

Tunisia

Contacts

Primary ContactKhaoula Bel Haj Ali, MD
belhajalikhaoula@yahoo.fr73106000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026