NCT04705636

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

December 14, 2020

Last Update Submit

January 20, 2021

Conditions

Chronic DiseaseCystic Fibrosis in Children

Keywords

Connected deviceLong-term therapyPneumologyAdherence therapyPediatric researchPediatric device support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Study of the reasons of low compliance or difficulties in taking the treatments

    At the inclusion

  • Assess the psycho-social impact of treatment and illness

    At the inclusion

  • Assess child's autonomy regarding his treatments

    3 months

  • Assess the intake treatments quality

    At the inclusion

  • Evaluate any negative impacts associated with the use of the robot

    3 months

  • +11 more secondary outcomes

Study Arms (1)

Connected device

EXPERIMENTAL

Connected device for three months period to support children care

Device: Connected device named "Leo" from Ludocare society

Interventions

Connected device named "Leo" from Ludocare societyDEVICE

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.

Connected device

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chu Rennes

Rennes, 35000, France

NOT YET RECRUITING

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, 22000, France

RECRUITING

Related Publications (8)

  • 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.

    PMID: 14667488RESULT

  • 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.

    PMID: 19416142RESULT

  • 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.

    PMID: 16387243RESULT

  • 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.

    PMID: 8658364RESULT

  • 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.

    PMID: 18304896RESULT

  • 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.

    PMID: 27060726RESULT

  • 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.

    PMID: 25233386RESULT

  • 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.

    PMID: 28056541RESULT

Related Links

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie JAMIN

    Centre Hospitalier de Saint-Brieuc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie JAMIN

CONTACT

+33296017818marie.jamin@ch-stbrieuc.fr

Gwenaëlle LE GARFF

CONTACT

+33296017277gwenaelle.legarff@armorsante.bzh

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

January 12, 2021

Study Start

January 20, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)