Clinical trial NCT04705636: Use of a Connected Companion in Children With Cystic Fibrosis
Official title: Use of a Connected Companion in Children With Cystic Fibrosis - COMPANION-CF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis in Children
Chronic Disease
Keywords: Connected device
Long-term therapy
Pneumology
Adherence therapy
Pediatric research
Pediatric device support
Lead sponsor: Centre Hospitalier de Saint-Brieuc
Sponsor class: OTHER
Collaborators: name: Rennes University Hospital
First posted: 2021-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate therapeutic adherence of children with cystic fibrosis aged 3 to 11 years with help of a connected medical companion
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
measure: Study of the reasons of low compliance or difficulties in taking the treatments
timeFrame: At the inclusion
measure: Assess the psycho-social impact of treatment and illness
timeFrame: At the inclusion
measure: Assess child's autonomy regarding his treatments
timeFrame: 3 months
measure: Assess the intake treatments quality
timeFrame: At the inclusion
measure: Evaluate any negative impacts associated with the use of the robot
timeFrame: 3 months
measure: Evaluate any negative impacts associated with the use of the robot
timeFrame: 4 to 6 months
measure: Assess the psycho-social impact of treatment and illness
timeFrame: at the inclusion
measure: Assess the psycho-social impact of treatment and illness
timeFrame: 3 months
measure: Assess the psycho-social impact of treatment and illness
timeFrame: 4 to 6 months
measure: Study of the reasons of low compliance or difficulties in taking the treatments
timeFrame: 3 months
measure: Assess the psycho-social impact of treatment and illness
timeFrame: 3 months
measure: Assess the intake treatments quality
timeFrame: 3 months
measure: Study of the reasons of low compliance or difficulties in taking the treatments
timeFrame: 4 to 6 months
measure: Assess the psycho-social impact of treatment and illness
timeFrame: 4 to 6 months
measure: Assess child's autonomy regarding his treatments
timeFrame: 4 to 6 months
measure: Assess the intake treatments quality
timeFrame: 4 to 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Chu Rennes
city: Saint-Brieuc
country: France
facility: Centre Hospitalier de Saint-Brieuc
Study officials:
affiliation: Centre Hospitalier de Saint-Brieuc
name: Marie JAMIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.
citation: Jentzsch NS, Camargos PAM, Colosimo EA, Bousquet J. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy. 2009 Oct;64(10):1458-1462. doi: 10.1111/j.1398-9995.2009.02037.x. Epub 2009 Mar 28.
citation: Zindani GN, Streetman DD, Streetman DS, Nasr SZ. Adherence to treatment in children and adolescent patients with cystic fibrosis. J Adolesc Health. 2006 Jan;38(1):13-7. doi: 10.1016/j.jadohealth.2004.09.013.
citation: Conway SP, Pond MN, Hamnett T, Watson A. Compliance with treatment in adult patients with cystic fibrosis. Thorax. 1996 Jan;51(1):29-33. doi: 10.1136/thx.51.1.29.
citation: Arias Llorente RP, Bousono Garcia C, Diaz Martin JJ. Treatment compliance in children and adults with cystic fibrosis. J Cyst Fibros. 2008 Sep;7(5):359-67. doi: 10.1016/j.jcf.2008.01.003. Epub 2008 Mar 4.
citation: Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.
citation: O'Donohoe R, Fullen BM. Adherence of subjects with cystic fibrosis to their home program: a systematic review. Respir Care. 2014 Nov;59(11):1731-46. doi: 10.4187/respcare.02990. Epub 2014 Jul 15.
citation: Britto MT, Rohan JM, Dodds CM, Byczkowski TL. A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. Clin Pediatr (Phila). 2017 Dec;56(14):1336-1344. doi: 10.1177/0009922816684857. Epub 2017 Jan 5.