Cardiovascular DiseaseNCT02237404
Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers
A study testing Telemedicine System in people with Cardiovascular Disease, run by University of Tromso at 1 site in Norway.
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
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Nov 2017
- 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
Official title: Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.
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 06 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 3 different moments (pre-implant and months 1, and 6 post-implantation).
Pacemakers that are going to be used in the project:
- Remote monitoring group: Biotronik Estella SR-T and DR-T \& Biotronik Evia SR-T and DR-T.
- Hospital monitoring group: St Jude Medical Endurity SR and DR \& Sorin Reply 200 SR and DR.
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of Health-Related Quality of Life questionnaires and 3) Finally, 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: 6 months
Secondary outcomes (7)
Health-Related Quality of Life
EuroQol-5Dimensions (EQ-5D)
Measured: 6 months
Health-Related Quality of Life
Minnesota Living With Heart Failure Questionnaire (MLHF)
Measured: 6 months
Safety
- Number of patients with Adverse Events
- Type of Adverse Events diagnosed
Measured: 6 months
Consultations and Hospitalizations unscheduled
Number of unscheduled visits and hospitalizations
Measured: 6 months
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: 6 months
Indirect cost
Maintenance of the medical consultation (hospital):
- Electricity
- Cleaning
- Furniture
- Health fungible
- Equipment investment
Measured: 6 months
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: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Lopez Villegas, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237404
- Sponsor's protocol ID
- 008WABELCMW2014A
- Status last verified
- Nov 2017
- First submitted
- 25 Aug 2014
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez-Villegas A, Catalan-Matamoros D, Peiro S, Lappegard KT, Lopez-Liria R. Cost-utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial. PLoS One. 2020 Jan 29;15(1):e0226188. doi: 10.1371/journal.pone.0226188. eCollection 2020.
PubMed 31995558Lopez-Liria R, Lopez-Villegas A, Enebakk T, Thunhaug H, Lappegard KT, Catalan-Matamoros D. Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial. Int J Environ Res Public Health. 2019 Jun 5;16(11):2001. doi: 10.3390/ijerph16112001.
PubMed 31195650Lopez-Villegas A, Catalan-Matamoros D, Lopez-Liria R, Enebakk T, Thunhaug H, Lappegard KT. Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial. BMC Geriatr. 2018 Sep 21;18(1):223. doi: 10.1186/s12877-018-0911-3.
PubMed 30241511
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.
- ClinicalTrials.gov ID
- NCT02237404
- Acronym / sponsor ID
- 008WABELCMW2014A
- Conditions
- Cardiovascular Disease
- Keywords
- Follow-Up studies, Biological Pacemakers, Telemedicine, Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 11 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 06 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 3 different moments (pre-implant and months 1, and 6 post-implantation).
Pacemakers that are going to be used in the project:
- Remote monitoring group: Biotronik Estella SR-T and DR-T \& Biotronik Evia SR-T and DR-T.
- Hospital monitoring group: St Jude Medical Endurity SR and DR \& Sorin Reply 200 SR and DR.
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of Health-Related Quality of Life questionnaires and 3) Finally, hospital and informal costs of patients with pacemakers will be estimated by the researches.
Study design
- Primary purpose
- Health services research
- Allocation
- 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: 6 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: 6 months
Health-Related Quality of Life
Time frame: 6 months
Safety
Time frame: 6 months
Consultations and Hospitalizations unscheduled
Time frame: 6 months
Direct costs
Time frame: 6 months
Indirect cost
Time frame: 6 months
Informal costs
Time frame: 6 months
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 Nov 2017.
- Derived from this study: PubMed 31995558Lopez-Villegas A, Catalan-Matamoros D, Peiro S, Lappegard KT, Lopez-Liria R. Cost-utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial. PLoS One. 2020 Jan 29;15(1):e0226188. doi: 10.1371/journal.pone.0226188. eCollection 2020.
- Derived from this study: PubMed 31195650Lopez-Liria R, Lopez-Villegas A, Enebakk T, Thunhaug H, Lappegard KT, Catalan-Matamoros D. Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial. Int J Environ Res Public Health. 2019 Jun 5;16(11):2001. doi: 10.3390/ijerph16112001.
- Derived from this study: PubMed 30241511Lopez-Villegas A, Catalan-Matamoros D, Lopez-Liria R, Enebakk T, Thunhaug H, Lappegard KT. Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial. BMC Geriatr. 2018 Sep 21;18(1):223. doi: 10.1186/s12877-018-0911-3.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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 University of Tromso at 1 site in Norway.
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 7 Nov 2017. 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 Norway. 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: 6 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 NCT02237404, which also lists 3 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 Nov 2017.