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mHealth to Early Detect Exacerbation for Older People With Heart Failure

NCT02506738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-07-23

No results posted yet for this study

Summary

The aim of the study was to demonstrate the effectiveness of telemonitoring functional status and vital signs to early detect heart failure exacerbation, and to minimize readmissions and length of hospitalisations.

Patients over 75 with heart failure were included after a hospitalisation due to heart failure exacerbation. Patients were assigned randomly into intervention or control. The intervention group comprised 47 patients who were assessed through telemonitoring, while 40 followed traditional clinical pathways.

Patients were followed-up for 3 months after discharge, collecting emergency visits and readmissions due to a new heart failure exacerbation. Those patients in the intervention group used a commercial telemedicine system: Careline H@me, which was provided by the company SALUDNOVA. They system was personalized by adding the functional status monitoring capabilities. Thus, the system collected vital signs (i.e. blood pressure, heart rate, respiratory rate, oxygen saturation, glucose, and weight); symptoms of decompensated heart failure (i.e. dyspnoea and orthopnoea); and functional status (i.e. part of the Short Physical Performance Battery, SPPB) and a brief questionnaire (i.e. Do you have the medication?) every 48 hours.

Two staff geriatricians at the Hospital Universitario de Getafe accessed, during working days, a secured dedicated web-portal to assess the progression of their patients, evaluated through the monitored variables and the self reported symptoms. They reacted to the data, if needed, making a phone call or visiting the patient. Besides, patients could contact the geriatricians or attending the emergency room as usually.

After completion, we analysed the results. First, we carried out a descriptive analysis of the data. Later, we analysed the effects of the intervention with telemedicine and the predictive values of the different measured variables through logistic regressions.

Conditions

Interventions

DEVICE

Intervention using mHealth

Patients in the intervention used at home a mobile system to monitor their clinical and health status.

Sponsors & Collaborators

  • SALUDNOVA SOLUTION S.L

    collaborator UNKNOWN

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital Universitario Getafe

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-10-31
Completion
2013-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506738 on ClinicalTrials.gov