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CompletedNCT01914588Updated Aug 2, 2013

Multiparametric Telemonitoring In Elderly People With Chronic Heart Failure

An interventional study of Telemonitoring and Standard care in Heart Failure, sponsored by Campus Bio-Medico University. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by Campus Bio-Medico University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 100 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with heart failure

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment precluding the use of the experimental device
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Telemonitoring + Standard care

    Procedure: Telemonitoring · Other: Standard care

  • Active comparator
    Standard care

    Other: Standard care

Interventions

  • ProcedureTelemonitoring

    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.

  • OtherStandard 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

06

What researchers measure

Primary outcomes

  1. Hospital admissions or death

    Rate of hospital admissions for any reason or death

    Time frame: 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

    Time frame: Six months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01914588
Lead sponsor
Campus Bio-Medico University
Responsible party
Raffaele Antonelli Incalzi (Director, Unit of Geriatrics, Campus Bio-Medico University) — Principal investigator
First posted
Aug 2, 2013
Start date
Jun 2012
Primary completion
Feb 2013
Completion
Jul 2013
Last update
Aug 2, 2013

Study contacts

Raffaele Antonelli Incalzi, MD
principal investigator · Campus Bio-Medico University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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