Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients

Heart Failure Clinical Trial

— HIS2R  

Official title:

Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04866550
• Other study ID #: 2020-005-HIS2R
• Status: Recruiting
• Start date: June 25, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2022
• Source: Université de Reims Champagne-Ardenne
• Contact: Jean-Luc NOVELLA
• Phone: 03 26 78 44 10
• Email: jlnovella[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic diseases are frequent (around 10% of the total population and 30% after 60 years) and accelerate age-related functional decline. Concerning cross-border patients, use of health services can be delayed given the distances, the lack of rapid road access and the limited availability of public transport and the complex organization of coordinated care. One of the ways to reduce acute exacerbations and preserve the quality of life of patients is to detect warning signs early. One of the ways to do this is to use new communication technologies.

Description:

The aim of the study is to assess feasibility of using a connected tablet to assess clinical parameters with an alert system in frailty patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients aged over 60
• Patients living at home
• Patients with heart failure and / or chronic obstructive pulmonary disease,
• Patients potentially requiring care cross-border (France and Belgium).
• Patients agreeing to participate to the study

Exclusion Criteria:

• Patients who do not speak French
• Patients with severe cognitive impairment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Frailty
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Data collection
Daily record of temperature, weight, heart rate, systolic blood pressure and oxygen saturation

Locations

Country	Name	City	State
France	Université de Reims Champagne-Ardenne	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alert according to the connected tablet	significant change in temperature (egal or more 38°), weight (variation of more than 5%), heart rate (less than 50 beats per minute or greater than 100), systolic blood pressure (less than 85 mmHg or greater than 160 mmHg) and / or oxygen saturation (variation of more than 4%)	12 months