Home Electronic Monitoring of Chronic Heart Failure

NCT02486887 | Unknown DMC

• 1 other identifier: P/2014/234
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to evaluate the effect of telemonitoring on mortality and rehospitalization due to heart failure on patients with chronic heart failure which have follow an educational program compared to a conventional follow-up during 1 year. The secondary objectives of the study are :

• Evaluate the cost of health
• Qualitatively evaluate telemonitoring on uses
• Evaluate quality of life

Conditions

Chronic Heart Failure

Keywords

telemonitoring

Outcome Measures

Primary Outcomes (1)

• Number of rehospitalizations due to acute heart failure and number of death due to heart failure

  1 year

Secondary Outcomes (7)

• Number and cost of consultations, treatments, hospitalization, transport, care of nurses ...

  1 year

• Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device

  1 year

• Interviews of patients and comptability of alarms of non-observance of weight, pulse and arterial pressure measure to evaluate acceptability and observance of telemonitoring device

  1 year

• Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy

  1 year

• Mean duration of stay during hospitalization

  1 year

Study Arms (2)

telemonitoring

EXPERIMENTAL

telemonitoring of weight, arterial pressure and heart rate at home with connection to a medical platform to monitor the evolution.

Device: telemonitoring of weight, pulse and blood pressure

conventional follow-up

NO INTERVENTION

conventional follow-up

Interventions

telemonitoring of weight, pulse and blood pressure DEVICE

telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic heart failure, NYHA II, III or IV
• Patients with follow-up in therapeutic education program and who had finish the program in 2011, 2012, 2013, 2014, 2015, 2016, 2017
• Information given and informed consent given

You may not qualify if:

• vital emergencies
• Refusal of patient, cardiologist or general practitioner
• Person who is not able to communicate or answer the questions
• Patients with problems of understanding as such dure to those diseases : dementia, Alzheimer disease, or neurological sequelae of cerebral stroke
• Patients who do not speak french
• Patients under guardianship
• Patients with other diseases which alter quality of life
• Patients who participate to another clinical trial
• Person private of liberty by court decision

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• AG2R La Mondiale: collaborator
• IMRI: collaborator
• AFPEC: collaborator
• H2AD: collaborator
• Pôle des Microtechniques de Besançon: collaborator

Study Sites (1)

CHU de Besançon

Besançon, France

RECRUITING

MeSH Terms

Interventions

Heart Rate; Blood Pressure

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Seronde Marie-France, PH

CONTACT

0033381668185; mfseronde@chu-besancon.fr

Sall Fatimata, SC

CONTACT

fatimata.sarr@chu-besancon.fr

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: June 1, 2015
• First Posted: July 1, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

FR (1)