Use of a Connected Companion in Children With Cystic Fibrosis
NCT ID: NCT04705636
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-01-20
2021-06-30
Brief Summary
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This study will be conducted at the University Hospital Center of Rennes and Hospital Center of Saint-Brieuc.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Connected device
Connected device for three months period to support children care
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
11 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Centre Hospitalier de Saint-Brieuc
OTHER
Responsible Party
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Principal Investigators
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Marie JAMIN
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier de Saint-Brieuc
Locations
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Chu Rennes
Rennes, , France
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, , France
Countries
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Central Contacts
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Facility Contacts
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Eric DENEUVILLE
Role: primary
Marie JAMIN
Role: primary
References
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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.
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.
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.
Related Links
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Maladies : Comment les applications et objets connectés peuvent aider les enfants à prendre leur traitement ?
Other Identifiers
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ID-RCB
Identifier Type: REGISTRY
Identifier Source: secondary_id
CHSB_202010_P3_COMPANION-CF
Identifier Type: -
Identifier Source: org_study_id
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