Cardiovascular DiseaseNCT02234245
Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
A study testing Telemedicine System in people with Cardiovascular Disease, run by Universidad de Almeria at 1 site in Spain.
Trial summary
The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers. The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Telemedicine System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2012to Oct 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age
- Have a pacemaker implanted
- Understand and be able to properly perform self-monitoring at home
Who cannot join
- Be participating in another study
- Refuse to participate in the study
- Have implanted a different cardiac device to the pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.
The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.
Read the detailed description
Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.
Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.
In the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.
During the 12 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and 5 years post-implantation).
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of health-related quality of life, functional capacity questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers will be estimated by the researches.
- Conditions
- Cardiovascular Disease
- Being tested
- Telemedicine System
- Keywords
- Follow-Up studies, Biological Pacemakers, Telemedicine, Efficiency
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine SystemDevice
Also called Patients are monitorized from hospital
Telemedicine System is used in remote monitoring group
| Study group | Role | What they receive |
|---|---|---|
| Hospital monitoring of pacemakers | No intervention | Patients have to go to the hospital to be monitorized |
| Remote monitoring of pacemakers | Experimental | Telemedicine System:
Patients have not to go to the hospital to be monitorized Receives: Device: Telemedicine System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical features
Selected variables from the medical history records:
- gender
- age
- indication for the implantation of the pacemaker.
- comorbidities
- pharmacological treatment
- vital signs
- pacemaker parameters
Measured: 12 months
Secondary outcomes (7)
Health-Related Quality of Life
EuroQol-5Dimensions (EQ-5D)
Measured: 5 years
Functional capacity
Duke Activity Status Index (DASI).
Measured: 5 years
Direct costs
Direct costs taken into account:
- pacemakers' costs´(device implanted)
- hospitalizations' costs
- consultations' costs (hospital)
- prescribed medical transport's cost
- health personnel costs
- pharmaceutical costs
Measured: 5 years
Indirect cost
Maintenance of the medical consultation (hospital):
- electricity
- cleaning
- furniture
- Health fungible
- equipment investment
Measured: 5 years
Informal costs
Costs related to the care and displacements of patients to hospital:
- displacement costs to hospital
- Accommodation costs
- Cost of meals
- Costs for caregivers
Measured: 5 years
Number of patients with Adverse Events
Number of patients with Adverse Events
- type of Adverse Events diagnosed
Measured: 5 years
Consultations and Hospitalizations unscheduled
- number of unscheduled visits and hospitalizations
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Lopez Villegas, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234245
- Sponsor's protocol ID
- CEIC-AL 53/2012
- Status last verified
- May 2023
- First submitted
- 28 Aug 2014
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Catalan-Matamoros D, Lopez-Villegas A, Leal Costa C, Bautista-Mesa R, Robles-Musso E, Rocamora Perez P, Lopez-Liria R. A non-randomized clinical trial to examine patients' experiences and communication during telemonitoring of pacemakers after five years follow-up. PLoS One. 2021 Dec 23;16(12):e0261158. doi: 10.1371/journal.pone.0261158. eCollection 2021.
PubMed 34941904Bautista-Mesa RJ, Lopez-Villegas A, Peiro S, Catalan-Matamoros D, Robles-Musso E, Lopez-Liria R, Leal-Costa C. Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study. BMC Geriatr. 2020 Nov 16;20(1):474. doi: 10.1186/s12877-020-01883-3.
PubMed 33198629Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study. Clin Res Cardiol. 2016 Apr;105(4):307-13. doi: 10.1007/s00392-015-0921-5. Epub 2015 Sep 30.
PubMed 26423396Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. [Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months]. Rev Esp Salud Publica. 2015 Apr;89(2):149-58. doi: 10.4321/S1135-57272015000200004. Spanish.
PubMed 26121625
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
- ClinicalTrials.gov ID
- NCT02234245
- Acronym / sponsor ID
- CEIC-AL 53/2012
- Conditions
- Cardiovascular Disease
- Keywords
- Follow-Up studies, Biological Pacemakers, Telemedicine, Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Sep 2014 (estimated)
- 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 purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.
The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.
Detailed description
Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.
Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.
In the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.
During the 12 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and 5 years post-implantation).
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of health-related quality of life, functional capacity questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers will be estimated by the researches.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital monitoring of pacemakers | No intervention | –Patients have to go to the hospital to be monitorized |
| Remote monitoring of pacemakers | Experimental | Device: Telemedicine SystemTelemedicine System: Patients have not to go to the hospital to be monitorized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be 18 years of age
- Have a pacemaker implanted
- Understand and be able to properly perform self-monitoring at home
Key exclusion criteria (3 listed)
- Be participating in another study
- Refuse to participate in the study
- Have implanted a different cardiac device to the pacemaker
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 |
|---|---|---|
| Telemedicine SystemAlso: Patients are monitorized from hospitalTelemedicine System is used in remote monitoring group | Device | Remote monitoring of pacemakers |
Primary outcome
Clinical features
Time frame: 12 months
Selected variables from the medical history records: * gender * age * indication for the implantation of the pacemaker. * comorbidities * pharmacological treatment * vital signs * pacemaker parameters
7 secondary outcomes
Health-Related Quality of Life
Time frame: 5 years
Functional capacity
Time frame: 5 years
Direct costs
Time frame: 5 years
Indirect cost
Time frame: 5 years
Informal costs
Time frame: 5 years
Number of patients with Adverse Events
Time frame: 5 years
Consultations and Hospitalizations unscheduled
Time frame: 5 years
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 10 May 2023.
- Derived from this study: PubMed 34941904Catalan-Matamoros D, Lopez-Villegas A, Leal Costa C, Bautista-Mesa R, Robles-Musso E, Rocamora Perez P, Lopez-Liria R. A non-randomized clinical trial to examine patients' experiences and communication during telemonitoring of pacemakers after five years follow-up. PLoS One. 2021 Dec 23;16(12):e0261158. doi: 10.1371/journal.pone.0261158. eCollection 2021.
- Derived from this study: PubMed 33198629Bautista-Mesa RJ, Lopez-Villegas A, Peiro S, Catalan-Matamoros D, Robles-Musso E, Lopez-Liria R, Leal-Costa C. Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study. BMC Geriatr. 2020 Nov 16;20(1):474. doi: 10.1186/s12877-020-01883-3.
- Derived from this study: PubMed 26423396Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study. Clin Res Cardiol. 2016 Apr;105(4):307-13. doi: 10.1007/s00392-015-0921-5. Epub 2015 Sep 30.
- Derived from this study: PubMed 26121625Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. [Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months]. Rev Esp Salud Publica. 2015 Apr;89(2):149-58. doi: 10.4321/S1135-57272015000200004. Spanish.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine System in people with Cardiovascular Disease, run by Universidad de Almeria 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 3 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 10 May 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 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?
Clinical features (time frame: 12 months). 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 NCT02234245, which also lists 4 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 10 May 2023.