Use of a Connected Companion in Children With Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Cystic Fibrosis in Children, Chronic Disease

Intervention / Treatment
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* Device: Connected device named Leo from Ludocare society


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected device<br>Connected device for three months period to support children care | Device: Connected device named Leo from Ludocare society<br>* Connected device named Leo from Ludocare society will be allocated to each child for three-months period. During this time, child will be helped to take all of his medication and specific care by this connected device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate therapeutic adherence of children with cystic fibrosis aged 3 to 11 years with help of a connected medical companion | The main evaluation criterion will be the overall compliance of the cohort in percentage terms. These data from connected companion will be refined for each type of treatment: pancreatic extracts, inhaled treatments, CFTR modulator, antibiotics, vitamins, laxative treatment, antacids, bile acids, food supplements, physiotherapy. For each treatment, the data take or not take will be treated by device and provide for statistical analysis in percentage. Each percentage will be grouped in global percentage will be therapeutic adherence all over study. | Through study completion, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the reasons of low compliance or difficulties in taking the treatments | Questionnaire for parents with up to 15 treatments which provide the major difficulties (to be indicated in order, from the most difficult to the simplest, with checked answers; no specific scale available) | At the inclusion | 
| Assess the psycho-social impact of treatment and illness | Questionnaire for parents on child's behaviours in regard to taking treatment and illness (scale from 0 to 10, , highers scores mean better outcome) | At the inclusion | 
| Assess child's autonomy regarding his treatments | Reporting in connected device | 3 months | 
| Assess the intake treatments quality | Questionnaire for parents on difficulties frequency with checked answers (no specific scale available) | At the inclusion | 
| Evaluate any negative impacts associated with the use of the robot | Questionnaire for parents on difficulties linked to the use of the robot with scale from 0 to 10, highers scores mean better outcome, and open ended questions (no specific scale is available) | 3 months | 
| Evaluate any negative impacts associated with the use of the robot | Questionnaire for parents on difficulties linked to the use of the robot with scale from 0 to 10, highers scores mean better outcome, and open ended questions (no specific scale is available) | 4 to 6 months | 
| Assess the psycho-social impact of treatment and illness | Questionnaire for children on his relation to his illness and his treatments (Color gradient scale with expressive smiley : red (sad), orange (a little bit sad), yellow (neutral), light green (good), dark green (very good) | at the inclusion | 
| Assess the psycho-social impact of treatment and illness | Questionnaire for children on his relation to his illness and his treatments (Color gradient scale with expressive smiley : red (sad), orange (a little bit sad), yellow (neutral), light green (good), dark green(very good) | 3 months | 
| Assess the psycho-social impact of treatment and illness | Questionnaire for children on his relation to his illness and his treatments (Color gradient scale with expressive smiley : red (sad), orange (a little bit sad), yellow (neutral), light green (good), dark green(very good) | 4 to 6 months | 
| Study of the reasons of low compliance or difficulties in taking the treatments | Questionnaire for parents with up to 15 treatments which provide the major difficulties (to be indicated in order, from the most difficult to the simplest, with checked answers; no specific scale available) | 3 months | 
| Assess the psycho-social impact of treatment and illness | Questionnaire for parents on child's behaviours in regard to taking treatment and illness (scale from 0 to 10, , highers scores mean better outcome) | 3 months | 
| Assess the intake treatments quality | Questionnaire for parents on difficulties frequency with checked answers (no specific scale available) | 3 months | 
| Study of the reasons of low compliance or difficulties in taking the treatments | Questionnaire for parents with up to 15 treatments which provide the major difficulties (to be indicated in order, from the most difficult to the simplest, with checked answers; no specific scale available) | 4 to 6 months | 
| Assess the psycho-social impact of treatment and illness | Questionnaire for parents on child's behaviours in regard to taking treatment and illness (scale from 0 to 10, , highers scores mean better outcome) | 4 to 6 months | 
| Assess child's autonomy regarding his treatments | Reporting in connected device | 4 to 6 months | 
| Assess the intake treatments quality | Questionnaire for parents on difficulties frequency with checked answers (no specific scale available) | 4 to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Connected device, Long-term therapy, Pneumology, Adherence therapy, Pediatric research, Pediatric device support