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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Disease; Cystic Fibrosis in Children
• Intervention / Treatment: Device: Connected device named "Leo" from Ludocare society

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Not yet recruiting
    • Chu Rennes
    • Contact: Eric DENEUVILLE
  • Saint-Brieuc, France, 22000
    • Recruiting
    • Centre Hospitalier de Saint-Brieuc
    • Contact: Marie JAMIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connected device; Connected device for three months period to support children care	Device: Connected device named "Leo" from Ludocare society; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Saint-Brieuc
• Collaborators: Rennes University Hospital
• Investigators: Principal Investigator: Marie JAMIN, Centre Hospitalier de Saint-Brieuc

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Maladies : Comment les applications et objets connectés peuvent aider les enfants à prendre leur traitement ?

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pneumology; Connected device; Long-term therapy; Adherence therapy; Pediatric research; Pediatric device support
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Chronic Disease; Cystic Fibrosis
• Other Study ID Numbers: CHSB_202010_P3_COMPANION-CF; ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No