Use of a Connected Companion in Children With Cystic Fibrosis
- Conditions
- Cystic Fibrosis in ChildrenChronic Disease
- Interventions
- Device: Connected device named "Leo" from Ludocare society
- Registration Number
- NCT04705636
- Lead Sponsor
- Centre Hospitalier de Saint-Brieuc
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Connected device Connected device named "Leo" from Ludocare society Connected device for three months period to support children care
- Primary Outcome Measures
Name Time Method Evaluate therapeutic adherence of children with cystic fibrosis aged 3 to 11 years with help of a connected medical companion Through study completion, up to 6 months 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.
- Secondary Outcome Measures
Name Time Method Assess the psycho-social impact of treatment and illness 4 to 6 months Questionnaire for parents on child's behaviours in regard to taking treatment and illness (scale from 0 to 10, , highers scores mean better outcome)
Evaluate any negative impacts associated with the use of the robot 4 to 6 months 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)
Study of the reasons of low compliance or difficulties in taking the treatments 4 to 6 months 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)
Assess child's autonomy regarding his treatments 4 to 6 months Reporting in connected device
Assess the intake treatments quality 4 to 6 months Questionnaire for parents on difficulties frequency with checked answers (no specific scale available)
Trial Locations
- Locations (2)
Chu Rennes
🇫🇷Rennes, France
Centre Hospitalier de Saint-Brieuc
🇫🇷Saint-Brieuc, France