Heart FailureNCT01914588
Multiparametric Telemonitoring In Elderly People With Chronic Heart Failure
A study testing Telemonitoring in people with Heart Failure, run by Campus Bio-Medico University.
Trial summary
Heart failure is a chronic disease associated with an increasing risk of morbidity, disability, repeated hospitalizations and mortality. Telemedicine could promptly identify signs of worsening cardiac disease in order to improve elderly patients' home care and quality of life by reducing the need of hospital… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jul 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with heart failure
Who cannot join
- Cognitive impairment precluding the use of the experimental device
About this study
Official title: Effectiveness of a Multiparametric Telemonitoring System on Prevention of Hospital Admissions and Mortality In Elderly People With Chronic Heart Failure
Heart failure is a chronic disease associated with an increasing risk of morbidity, disability, repeated hospitalizations and mortality. Telemedicine could promptly identify signs of worsening cardiac disease in order to improve elderly patients' home care and quality of life by reducing the need of hospital admissions and sanitary costs. The investigators present a randomized, parallel-group trial to test the ability of a multiparametric remote monitoring system, in addition to standard care, to promptly identify worsening of heart failure and prevent hospital admission and mortality.
Read the detailed description
The participants were recruited in two settings:
- Patients discharged with a first diagnosis of heart failure from the Geriatric Acute Care ward of a teaching hospital ("Policlinico Campus Bio-Medico", Rome, Italy);
- Patients with a principal diagnosis of heart failure attending the outpatients clinic of the same hospital.
All the participants were evaluated at baseline and at the end of the study using a multi-dimensional assessment including well validated and routinely used tools to screen geriatric patients in order to detect global, physical and instrumental autonomy and consequent degree of dependence, as well as cognitive status. The assessment tool included: Activities of daily living scale (ADL) and Instrumental activities of daily living scale (IADL); Abbreviated mental Test; Geriatric Depression Scale; Physical Activity Scale for the Elderly; Six-minute walking test; The Short Form Health Survey (SF-12); Cumulative Illness Rating Scale (CIRS); complete list of drugs.
Once written consent form was obtained, participants were allocated to the study groups in a 1:1 ratio using a computer-generated random list of number.
Participants were followed up for six months. Patients in the intervention group were monitored via a system called PHEBO (Platform for High tech Evaluation of Biometrics Observation) that consisted of a commercial Android-based smartphone and a kit of measurement instruments (sphygmomanometer, pulse oximeter and an electronic scale) with a bluetooth transmitter.
The smartphone received via bluetooth the readings from the measurement instruments, communicated in real-time the readings to the central component of the system and issued reminders for the patient when measurement was scheduled.
Patients in the telemonitoring group received a training session during which they were instructed on how to use the monitoring system and how to perform measurements in case of symptoms. At the end of the session correct comprehension of the system functioning was tested for each patient. A study physician was available on call during office hours to assist patients needing further instructions. A technician was also available in order to solve ingoing hardware malfunctioning. Participants unable to properly use the kit were excluded from the study.
The kit was able to record peripheral oxygen saturation, heart rate, systolic, diastolic and average blood pressure, body weight, average physical activity. We set a specific schedule of the measurements:
- Blood pressure and heart rate: three times a day
- Peripheral oxygen saturation: three times a day
- Body weight: once a day
- Physical activity: recorded continuously.
The data received were evaluated every day by a geriatrician. The monitor system displayed an alert when a measurement was outside a predetermined range. In case of abnormal readings, the physician contacted the patient to verify whether their symptoms had worsened or new symptoms had arose. In this event, the patient's adherence to therapy was checked and, if unsatisfactory, individually tailored interventions promoting adherence were carried up. Otherwise, an once appointment (for patients with milder abnormalities or symptoms) or a hospital admission was scheduled.
Participants not included in the intervention group received standard care. In particular, patients discharged from the acute care ward received detailed instruction about medical therapy and lifestyle counselling. A follow-up visit was scheduled at 1 month after the discharge. A geriatrician was available for telephonic support from Monday to Friday, two hours/day. Patients enrolled in the ambulatory setting were followed by planned visits and by their general practitioner.
- Conditions
- Heart Failure
- Being tested
- Telemonitoring, Standard care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringProcedure or surgery
Use of wearable sensors able to record peripheral oxygen saturation, heart rate, systolic, diastolic and average blood pressure, body weight, average physical activity, with automatic transmission to the monitoring central.
Standard careOther
- Detailed instruction about medical therapy and lifestyle counseling
- Telephonic support by a geriatrician, available from Monday to Friday, two hours/day
- Follow-up visits
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring + Standard care | Experimental | Not described Receives: Procedure: Telemonitoring; Other: Standard care |
| Standard care | Active comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admissions or death
Rate of hospital admissions for any reason or death
Measured: Six months
Secondary outcomes (1)
Acute heart failure events
Rate of acute heart failure, defined as a worsening of the patient's condition that necessitates a change in regular medications
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raffaele Antonelli Incalzi, Campus Bio-Medico University
- Investigators
- Raffaele Antonelli Incalzi, MD, Principal investigator, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914588
- Sponsor's protocol ID
- 09/2012 ComET CBM - PHEBO
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multiparametric Telemonitoring System on Prevention of Hospital Admissions and Mortality In Elderly People With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01914588
- Acronym / sponsor ID
- 09/2012 ComET CBM - PHEBO
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Aug 2013 (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.
Heart failure is a chronic disease associated with an increasing risk of morbidity, disability, repeated hospitalizations and mortality. Telemedicine could promptly identify signs of worsening cardiac disease in order to improve elderly patients' home care and quality of life by reducing the need of hospital admissions and sanitary costs. The investigators present a randomized, parallel-group trial to test the ability of a multiparametric remote monitoring system, in addition to standard care, to promptly identify worsening of heart failure and prevent hospital admission and mortality.
Detailed description
The participants were recruited in two settings:
- Patients discharged with a first diagnosis of heart failure from the Geriatric Acute Care ward of a teaching hospital ("Policlinico Campus Bio-Medico", Rome, Italy);
- Patients with a principal diagnosis of heart failure attending the outpatients clinic of the same hospital.
All the participants were evaluated at baseline and at the end of the study using a multi-dimensional assessment including well validated and routinely used tools to screen geriatric patients in order to detect global, physical and instrumental autonomy and consequent degree of dependence, as well as cognitive status. The assessment tool included: Activities of daily living scale (ADL) and Instrumental activities of daily living scale (IADL); Abbreviated mental Test; Geriatric Depression Scale; Physical Activity Scale for the Elderly; Six-minute walking test; The Short Form Health Survey (SF-12); Cumulative Illness Rating Scale (CIRS); complete list of drugs.
Once written consent form was obtained, participants were allocated to the study groups in a 1:1 ratio using a computer-generated random list of number.
Participants were followed up for six months. Patients in the intervention group were monitored via a system called PHEBO (Platform for High tech Evaluation of Biometrics Observation) that consisted of a commercial Android-based smartphone and a kit of measurement instruments (sphygmomanometer, pulse oximeter and an electronic scale) with a bluetooth transmitter.
The smartphone received via bluetooth the readings from the measurement instruments, communicated in real-time the readings to the central component of the system and issued reminders for the patient when measurement was scheduled.
Patients in the telemonitoring group received a training session during which they were instructed on how to use the monitoring system and how to perform measurements in case of symptoms. At the end of the session correct comprehension of the system functioning was tested for each patient. A study physician was available on call during office hours to assist patients needing further instructions. A technician was also available in order to solve ingoing hardware malfunctioning. Participants unable to properly use the kit were excluded from the study.
The kit was able to record peripheral oxygen saturation, heart rate, systolic, diastolic and average blood pressure, body weight, average physical activity. We set a specific schedule of the measurements:
- Blood pressure and heart rate: three times a day
- Peripheral oxygen saturation: three times a day
- Body weight: once a day
- Physical activity: recorded continuously.
The data received were evaluated every day by a geriatrician. The monitor system displayed an alert when a measurement was outside a predetermined range. In case of abnormal readings, the physician contacted the patient to verify whether their symptoms had worsened or new symptoms had arose. In this event, the patient's adherence to therapy was checked and, if unsatisfactory, individually tailored interventions promoting adherence were carried up. Otherwise, an once appointment (for patients with milder abnormalities or symptoms) or a hospital admission was scheduled.
Participants not included in the intervention group received standard care. In particular, patients discharged from the acute care ward received detailed instruction about medical therapy and lifestyle counselling. A follow-up visit was scheduled at 1 month after the discharge. A geriatrician was available for telephonic support from Monday to Friday, two hours/day. Patients enrolled in the ambulatory setting were followed by planned visits and by their general practitioner.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring + Standard care | Experimental | Procedure: Telemonitoring, Other: Standard care |
| Standard care | Active comparator | Other: Standard care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with heart failure
Key exclusion criteria (1 listed)
- Cognitive impairment precluding the use of the experimental device
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 |
|---|---|---|
| TelemonitoringUse of wearable sensors able to record peripheral oxygen saturation, heart rate, systolic, diastolic and average blood pressure, body weight, average physical activity, with automatic transmission to the monitoring central. | Procedure or surgery | Telemonitoring + Standard care |
| Standard care* Detailed instruction about medical therapy and lifestyle counseling * Telephonic support by a geriatrician, available from Monday to Friday, two hours/day * Follow-up visits | Other | Standard care, Telemonitoring + Standard care |
Primary outcome
Hospital admissions or death
Time frame: Six months
Rate of hospital admissions for any reason or death
1 secondary outcome
Acute heart failure events
Time frame: Six 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 2 Aug 2013.
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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.
Raffaele Antonelli Incalzi, MD principal investigator
Campus Bio-Medico University
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Heart Failure, run by Campus Bio-Medico University.
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 1 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Hospital admissions or death (time frame: Six months). 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 2 Aug 2013.