COPDNCT03505138
Impact of Telemedicine in the Rate of Readmission for COPD. Project CRONEX 3.0
A study testing Group intervention and health care system in people with COPD, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The prevalence of COPD is high and suppose one of the first public health problem in the world. It has a high morbidity and mortality and healthcare costs. The economic aspect is directly related to hospitalization, accounting for 45-50% of total expenditure of COPD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Group intervention and health care system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Feb 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COPD, which after evaluation of its clinical history, belonging to exacerbator phenotype (chronic bronchitic / emphysema) or mixed phenotype ("COPD-asthma") readmission (2 or more income in the previous year) and are stable least six weeks before inclusion in the study.
- Age over 18 years
- The patient or caregiver should be able to use the tablet type telematic tool for tracking and monitoring.
Who cannot join
- Patients with severe comorbidity grade IV heart failure, renal failure on hemodialysis or active neoplasia
- Patients with difficulties phone coverage
- Patients with lack of adequate social and family support.
- Patients who do not grant informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Telemedicine in the Rate of Readmission for COPD and Cost-effectiveness Analysis (e- Pneumo ) : Project CRONEX 3.0
The prevalence of COPD is high and suppose one of the first public health problem in the world. It has a high morbidity and mortality and healthcare costs. The economic aspect is directly related to hospitalization, accounting for 45-50% of total expenditure of COPD. Patients with frequent exacerbations generate most of the cost.
In these patients, there are not standardized treatments or monitoring in a medium or long term, but it seems reasonable that the combination of various interventions (programs self-care, active role of health professionals in consultations, home programs, group visits, establishment action plans for patients, use of communication technologies or social networks) may improve many patient outcomes.
The hypothesis of our work will be to introduce telemedicine platform to establish action plans for the patient, recognition of symptoms and exacerbations, treatments for the exacerbations, training material on COPD, smoking and inhalation therapy, establishment of a fast and fluid communication with pulmonologist, with the purpose of responding to various health problems that patients with COPD (exacerbator phenotype or ACO phenotype) may have. We will study the impact of this tool to reduce the rate income or readmission for the patients with COPD, analyzing it from the perspective of cost-effectiveness.
- Conditions
- COPD
- Being tested
- Group intervention, health care system
- Keywords
- COPD, hospitalization, telemedicine platform
- 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.
Group interventionDevice
Also called Telematic intervention
GROUP 1 (telematic group):
These patients will have a tablet connected via internet (Telefónica-e-Health). They have to measure their lung function, temperature, pulse oxymetry and symtoms questionnaire every week. The device (tablet) asks them about possible COPD exacerbation. If the patient has an exacerbation, the device offers them a treatment for this exacerbation and it begins a following of this exacerbation until resolution, every day.
The pneumologists will receive an alert in other tablet when the patients have an exacerbation or worsening of their diseases.
The period of monitoring is 1 year.
health care systemOther
GROUP 2 (conventional group or control group) Patients with a COPD exacerbation can go to their family physicians or emergency services and these physicians will establish a treatment and a monitoring of these exacerbation (conventional group).
The period of monitoring is 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Group intervention | Experimental | Conventional management for COPD will take place in our health care system more telematics intervention. Receives: Device: Group intervention |
| Group control | Active comparator | Is performed only conventional management of COPD in our health care system. Receives: Other: health care system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management.
outcome measure: the rate of readmissions during the study
Measured: one year
Secondary outcomes (14)
Conducting a cost-effectiveness study that allows us to estimate the incremental cost-effectiveness ratio (ICER) of this patient group compared with the control group.
outcome measure: incremental cost-effectiveness ratio (ICER) between these two arms
Measured: one year
Compare the quality of life of COPD patients by measuring CAT in study groups
outcome measure: quality of life measured by CAT questionnaire
Measured: one year
To study the evolution of lung function in both groups after 1 year of follow up.
outcome measure: lung function by spirometry (FEV1/FVC, FVC, FEV1)
Measured: one year
Analyze the survival at 12 months follow-up in each group.
outcome measure: number of deaths in each group to see the survival in this study
Measured: one year
Analyze a biomarker predictor of exacerbation severity.
outcome measure: PCR (mg/L)
Measured: one year
Analyze the inhaler compliance and adherence of treatment in both groups.
outcome measure: Morisky-Green´s scoring
Measured: one year
Make satisfaction survey patients and caregivers, comparing both study groups.
outcome measure: satisfaction (very satisfied, satisfied, unsatisfied, very unsatisfied)
Measured: one year
Compare the quality of life of patients by measuring EQ-5D in study groups
outcome measure: EQ-5D questionnaire
Measured: one year
Analyze a biomarker predictor of exacerbation severity.
outcome measure: fibrinogen (g/L)
Measured: one year
Analyze a biomarker predictor of exacerbation severity.
outcome measure: leukocytes (mil/mm3)
Measured: one year
Analyze a biomarker predictor of exacerbation severity.
outcome measure: eosinophils (mil/mm3)
Measured: one year
Analyze a biomarker predictor of exacerbation severity.
outcome measure: pro-BNP (pg/ml)
Measured: one year
Analyze a biomarker predictor of exacerbation severity.
outcome measure: cholesterol (mg/dL)
Measured: one year
Analyze a biomarker predictor of exacerbation severity.
outcome measure: proteins (mg/dL)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 May 2018
- Primary completion1 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Corral Penafiel, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Jaime Corral, MD, Principal investigator, Hospital San Pedro de Alcántara. Cáceres. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505138
- Sponsor's protocol ID
- CRONEX3.0
- Status last verified
- Apr 2018
- First submitted
- 5 Mar 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cosio BG, Agusti A. Update in chronic obstructive pulmonary disease 2009. Am J Respir Crit Care Med. 2010 Apr 1;181(7):655-60. doi: 10.1164/rccm.201001-0111UP. No abstract available.
PubMed 20335383Escarrabill J. Discharge planning and home care for end-stage COPD patients. Eur Respir J. 2009 Aug;34(2):507-12. doi: 10.1183/09031936.00146308.
PubMed 19648525Hurst JR, Fitzgerald-Khan F, Quint JK, Goldring JJ, Mikelsons C, Dilworth JP, Wedzicha JA. Use and utility of a 24-hour Telephone Support Service for 'high risk' patients with COPD. Prim Care Respir J. 2010 Sep;19(3):260-5. doi: 10.4104/pcrj.2010.00035.
PubMed 20571731Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
PubMed 12622605Jurado Gamez B, Feu Collado N, Jurado Garcia JC, Garcia Gil F, Munoz Gomariz E, Jimenez Murillo L, Munoz Cabrera L. Home intervention and predictor variables for rehospitalization in chronic obstructive pulmonary disease exacerbations. Arch Bronconeumol. 2013 Jan;49(1):10-4. doi: 10.1016/j.arbres.2012.08.003. Epub 2012 Oct 22. English, Spanish.
PubMed 23089685De Vries B, Darling-Fisher C, Thomas AC, Belanger-Shugart EB. Implementation and outcomes of group medical appointments in an outpatient specialty care clinic. J Am Acad Nurse Pract. 2008 Mar;20(3):163-9. doi: 10.1111/j.1745-7599.2007.00300.x.
PubMed 18336693Bischoff EW, Hamd DH, Sedeno M, Benedetti A, Schermer TR, Bernard S, Maltais F, Bourbeau J. Effects of written action plan adherence on COPD exacerbation recovery. Thorax. 2011 Jan;66(1):26-31. doi: 10.1136/thx.2009.127621. Epub 2010 Oct 30.
PubMed 21037270
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telemedicine in the Rate of Readmission for COPD and Cost-effectiveness Analysis (e- Pneumo ) : Project CRONEX 3.0
- ClinicalTrials.gov ID
- NCT03505138
- Acronym / sponsor ID
- CRONEX3.0
- Conditions
- COPD
- Keywords
- COPD, hospitalization, telemedicine platform
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 23 Apr 2018 (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.
The prevalence of COPD is high and suppose one of the first public health problem in the world. It has a high morbidity and mortality and healthcare costs. The economic aspect is directly related to hospitalization, accounting for 45-50% of total expenditure of COPD. Patients with frequent exacerbations generate most of the cost.
In these patients, there are not standardized treatments or monitoring in a medium or long term, but it seems reasonable that the combination of various interventions (programs self-care, active role of health professionals in consultations, home programs, group visits, establishment action plans for patients, use of communication technologies or social networks) may improve many patient outcomes.
The hypothesis of our work will be to introduce telemedicine platform to establish action plans for the patient, recognition of symptoms and exacerbations, treatments for the exacerbations, training material on COPD, smoking and inhalation therapy, establishment of a fast and fluid communication with pulmonologist, with the purpose of responding to various health problems that patients with COPD (exacerbator phenotype or ACO phenotype) may have. We will study the impact of this tool to reduce the rate income or readmission for the patients with COPD, analyzing it from the perspective of cost-effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group intervention | Experimental | Device: Group interventionConventional management for COPD will take place in our health care system more telematics intervention. |
| Group control | Active comparator | Other: health care systemIs performed only conventional management of COPD in our health care system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD, which after evaluation of its clinical history, belonging to exacerbator phenotype (chronic bronchitic / emphysema) or mixed phenotype ("COPD-asthma") readmission (2 or more income in the previous year) and are stable least six weeks before inclusion in the study.
- Age over 18 years
- The patient or caregiver should be able to use the tablet type telematic tool for tracking and monitoring.
Key exclusion criteria (4 listed)
- Patients with severe comorbidity grade IV heart failure, renal failure on hemodialysis or active neoplasia
- Patients with difficulties phone coverage
- Patients with lack of adequate social and family support.
- Patients who do not grant informed consent
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 |
|---|---|---|
| Group interventionAlso: Telematic interventionGROUP 1 (telematic group): These patients will have a tablet connected via internet (Telefónica-e-Health). They have to measure their lung function, temperature, pulse oxymetry and symtoms questionnaire every week. The device (tablet) asks them about possible COPD exacerbation. If the patient has an exacerbation, the device offers them a treatment for this exacerbation and it begins a following of this exacerbation until resolution, every day. The pneumologists will receive an alert in other tablet when the patients have an exacerbation or worsening of their diseases. The period of monitoring is 1 year. | Device | Group intervention |
| health care systemGROUP 2 (conventional group or control group) Patients with a COPD exacerbation can go to their family physicians or emergency services and these physicians will establish a treatment and a monitoring of these exacerbation (conventional group). The period of monitoring is 1 year. | Other | Group control |
Primary outcome
Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management.
Time frame: one year
outcome measure: the rate of readmissions during the study
14 secondary outcomes
Conducting a cost-effectiveness study that allows us to estimate the incremental cost-effectiveness ratio (ICER) of this patient group compared with the control group.
Time frame: one year
Compare the quality of life of COPD patients by measuring CAT in study groups
Time frame: one year
To study the evolution of lung function in both groups after 1 year of follow up.
Time frame: one year
Analyze the survival at 12 months follow-up in each group.
Time frame: one year
Analyze a biomarker predictor of exacerbation severity.
Time frame: one year
Analyze the inhaler compliance and adherence of treatment in both groups.
Time frame: one year
Make satisfaction survey patients and caregivers, comparing both study groups.
Time frame: one year
Compare the quality of life of patients by measuring EQ-5D in study groups
Time frame: one year
Analyze a biomarker predictor of exacerbation severity.
Time frame: one year
Analyze a biomarker predictor of exacerbation severity.
Time frame: one year
Analyze a biomarker predictor of exacerbation severity.
Time frame: one year
Analyze a biomarker predictor of exacerbation severity.
Time frame: one year
Analyze a biomarker predictor of exacerbation severity.
Time frame: one year
Analyze a biomarker predictor of exacerbation severity.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Background: PubMed 20335383Cosio BG, Agusti A. Update in chronic obstructive pulmonary disease 2009. Am J Respir Crit Care Med. 2010 Apr 1;181(7):655-60. doi: 10.1164/rccm.201001-0111UP. No abstract available.
- Background: PubMed 19648525Escarrabill J. Discharge planning and home care for end-stage COPD patients. Eur Respir J. 2009 Aug;34(2):507-12. doi: 10.1183/09031936.00146308.
- Background: PubMed 20571731Hurst JR, Fitzgerald-Khan F, Quint JK, Goldring JJ, Mikelsons C, Dilworth JP, Wedzicha JA. Use and utility of a 24-hour Telephone Support Service for 'high risk' patients with COPD. Prim Care Respir J. 2010 Sep;19(3):260-5. doi: 10.4104/pcrj.2010.00035.
- Background: PubMed 12622605Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
- Background: PubMed 23089685Jurado Gamez B, Feu Collado N, Jurado Garcia JC, Garcia Gil F, Munoz Gomariz E, Jimenez Murillo L, Munoz Cabrera L. Home intervention and predictor variables for rehospitalization in chronic obstructive pulmonary disease exacerbations. Arch Bronconeumol. 2013 Jan;49(1):10-4. doi: 10.1016/j.arbres.2012.08.003. Epub 2012 Oct 22. English, Spanish.
- Background: PubMed 18336693De Vries B, Darling-Fisher C, Thomas AC, Belanger-Shugart EB. Implementation and outcomes of group medical appointments in an outpatient specialty care clinic. J Am Acad Nurse Pract. 2008 Mar;20(3):163-9. doi: 10.1111/j.1745-7599.2007.00300.x.
- Background: PubMed 21037270Bischoff EW, Hamd DH, Sedeno M, Benedetti A, Schermer TR, Bernard S, Maltais F, Bourbeau J. Effects of written action plan adherence on COPD exacerbation recovery. Thorax. 2011 Jan;66(1):26-31. doi: 10.1136/thx.2009.127621. Epub 2010 Oct 30.
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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.
Jaime Corral, MD principal investigator
Hospital San Pedro de Alcántara. Cáceres. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group intervention and health care system in people with COPD, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 7 Mar 2019. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505138, which also lists 7 linked publications.
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 7 Mar 2019.