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

Hospital Center of Saint-Brieuc

Status

Unknown

Conditions

Chronic Disease

Cystic Fibrosis in Children

Treatments

Device: Connected device named "Leo" from Ludocare society

Study type

Interventional

Funder types

Other

Identifiers

NCT04705636

CHSB_202010_P3_COMPANION-CF

ID-RCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

3 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Child volunteer from 3 to 11 years old
Affected by cystic fibrosis
With a prescription containing at least two medications twice a day
Affiliation to the national health insurance
Child and holder of the exercise of parental authority understands and speaks French
The person exercising parental authority must have reached the age of majority.
Collection of the written consent of one of the holders of the exercise of parental authority

Exclusion criteria

Non-voluntary child, under 3 years of age or over 12 years of age
Family reluctant to technology
Family without smartphone and/or wifi connection
Failure to obtain the written consent of one of the holders of the exercise of parental authority
Child involved in research involving the human person