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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT01914588
Study groupRoleWhat they receive
Telemonitoring + Standard careExperimentalNot described
Receives: Procedure: Telemonitoring; Other: Standard care
Standard careActive comparatorNot described
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital admissions or death

    Rate of hospital admissions for any reason or death

    Measured: Six months

Secondary outcomes (1)
  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.

  1. First posted2 Aug 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionFeb 2013
  4. Study completionJul 2013

Resources

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)
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

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.

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