mHealth to Early Detect Exacerbation for Older People With Heart Failure

NCT02506738 | Completed DMC

• 3 other identifiers: HUGetafePI09/91070CEIC-09/37
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Heart Failure

Keywords

telemonitoring; mHealth; functional status; older people

Outcome Measures

Primary Outcomes (1)

• Readmissions

  Number of visits to the emergency room that require readmission

  3 months

Secondary Outcomes (3)

• Emergency visits

  3 months

• Worsening

  3 months

• Readmissions length

  3 months

Study Arms (2)

Intervention using mHealth

ACTIVE COMPARATOR

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

Device: Intervention using mHealth

Control

NO INTERVENTION

Patients in the control group received the usual care.

Interventions

Intervention using mHealth DEVICE

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

Intervention using mHealth

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients admitted at the acute care unit at the Hospital Universitario de Getafe who are diagnosed with Heart Failure as primary cause for admission.

You may not qualify if:

• Moderate/severe cognitive impairment (MMSE\<23)
• Visual/auditory deficits, communication problems
• Moderate/severe non-reversible functional impairment (Barthel\<60)
• To be institutionalized
• To be discharged to a Functional Rehabilitation Hospital

Sponsors & Collaborators

• Hospital Universitario Getafe: lead
• SALUDNOVA SOLUTION S.L: collaborator
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: August 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 23, 2015

Record last verified: 2015-07