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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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.
Chu Rennes
Rennes, France
NOT_YET_RECRUITINGCentre Hospitalier de Saint-Brieuc
Saint-Brieuc, France
RECRUITINGEvaluate 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.
Time frame: Through study completion, up 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)
Time frame: 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)
Time frame: At the inclusion
Assess child's autonomy regarding his treatments
Reporting in connected device
Time frame: 3 months
Assess the intake treatments quality
Questionnaire for parents on difficulties frequency with checked answers (no specific scale available)
Time frame: At the inclusion
Evaluate any negative impacts associated with the use of the robot
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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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 3 months
Assess the intake treatments quality
Questionnaire for parents on difficulties frequency with checked answers (no specific scale available)
Time frame: 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)
Time frame: 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)
Time frame: 4 to 6 months
Assess child's autonomy regarding his treatments
Reporting in connected device
Time frame: 4 to 6 months
Assess the intake treatments quality
Questionnaire for parents on difficulties frequency with checked answers (no specific scale available)
Time frame: 4 to 6 months