Use of a Connected Companion in Children With Cystic Fibrosis — COMPANION-CF  

Chronic Disease Clinical Trial

Official title: Use of a Connected Companion in Children With Cystic Fibrosis - COMPANION-CF

Status Recruiting

Clinical Trial Summary

The study will be conducted over a 6 months period. For the first three months, the child will be accompagned with a connected companion. After this period, the companion will be removed for three months in oder to prove this companion could improve treatment adherence for children suffering from cytolisis fibrosis.

This study will be conducted at the University Hospital Center of Rennes and Hospital Center of Saint-Brieuc.

Clinical Trial Description

In developed countries, chronic diseases with long-term therapy adherence is about 50%, according to the WHO report, and the adherence rate for regular intake of preventive therapies decreases to 28%.

For cystic fibrosis, rates are not much higher. Optimistic articles report an average compliance rate of 60%. Other articles report a rate of 50% which varies according to the age of the patient, the intake treatment complexity and burdensome drug treatment (physiotherapy achieves the lowest adherence with 38%), the disease understanding and the interest of treatment persuasion. Low adherence can also be the result of incorrect use of administration devices, for example for inhaled treatments. Technical errors are very frequent and affect around 30% of patients.

Families with children suffering from cystic fibrosis need daily support. Health professionals need to relay their recommendations at home. This is why new and funny tools dedicated to children with chronic illnesses are needed.

This trial will study the impact of connected companion named LEO® created by Ludocare company.

Study will be conducted as :

• V0 : Companion given to the child

• V1 : Companion removed after 3 months of use

• V2 : Follow-up done between 1 and 3 months after the period without companion ;

Related Conditions & MeSH terms

• Chronic Disease
• Cystic Fibrosis
• Cystic Fibrosis in Children
• Fibrosis

• NCT number: NCT04705636
• Study type: Interventional
• Source: Centre Hospitalier de Saint-Brieuc
• Contact: Marie JAMIN
• Phone: +33296017818
• Email: marie.jamin@ch-stbrieuc.fr
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Completion date: June 2021