NCT01914588

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

Enrollment Period

8 months

First QC Date

July 25, 2013

Last Update Submit

July 31, 2013

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Hospital admissions or death

    Rate of hospital admissions for any reason or death

    Six months

Secondary Outcomes (1)

  • Acute heart failure events

    Six months

Study Arms (2)

Telemonitoring + Standard care

EXPERIMENTAL
Procedure: TelemonitoringOther: Standard care

Standard care

ACTIVE COMPARATOR
Other: Standard care

Interventions

TelemonitoringPROCEDURE

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.

Telemonitoring + Standard care
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

Standard careTelemonitoring + Standard care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with heart failure

You may not qualify if:

  • Cognitive impairment precluding the use of the experimental device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Raffaele Antonelli Incalzi, MD

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Unit of Geriatrics

Study Record Dates

First Submitted

July 25, 2013

First Posted

August 2, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2013

Study Completion

July 1, 2013

Last Updated

August 2, 2013

Record last verified: 2013-07