COPDTLM_COPDNCT06135025
Usefulness and Efficacy of Telemonitoring of Patients With COPD
A study testing Telemonitoring in people with COPD, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Aug 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years old with prior diagnosis of COPD according to GOLD criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Khaoula Bel Haj Ali
Monastir, 5020
Khaoula Bel Haj Ali, 73106000, belhajalikhaoula@yahoo.fr
About this study
Official title: 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.
Read the 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
- Being tested
- Telemonitoring
- Keywords
- exacerbation, hospitalization, telemonitoring, acute
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation rate
rate of COPD exacerbation
Measured: 30 days after inclusion
Need for hospitalization for AECOP
rate of hospitalization for AECOP
Measured: 30 days after inclusion
Mortality
rate of Death from any cause
Measured: 30 days after inclusion
Secondary outcomes (1)
EFI
time with free interval from exacerbation
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Aug 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Khaoula Bel Haj Ali, MD, Study director, CHU Fattouma Bourguiba Monastir, service des urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135025
- Sponsor's protocol ID
- TLM_COPD
- Acronym
- TLM_COPD
- Status last verified
- Nov 2023
- First submitted
- 18 Aug 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usefulness and Efficacy of Telemonitoring of Patients With COPD
- ClinicalTrials.gov ID
- NCT06135025
- Acronym / sponsor ID
- TLM_COPD / TLM_COPD
- Conditions
- COPD
- Keywords
- exacerbation, hospitalization, telemonitoring, acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TLM_group | Active comparator | Other: Telemonitoringthe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged over 18 years old with prior diagnosis of COPD according to GOLD criteria
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoringthe 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. | Other | TLM_group |
Primary outcome
Exacerbation rate
Time frame: 30 days after inclusion
rate of COPD exacerbation
Need for hospitalization for AECOP
Time frame: 30 days after inclusion
rate of hospitalization for AECOP
Mortality
Time frame: 30 days after inclusion
rate of Death from any cause
1 secondary outcome
EFI
Time frame: 30 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaoula Bel Haj Ali, MD study director
CHU Fattouma Bourguiba Monastir, service des urgences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with COPD, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaoula Bel Haj Ali, MD (73106000, belhajalikhaoula@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation rate (time frame: 30 days after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.