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Cystic Fibrosis in ChildrenCOMPANION-CFNCT04705636

Use of a Connected Companion in Children With Cystic Fibrosis

A study testing Connected device named "Leo" from Ludocare society in people with Cystic Fibrosis in Children and Chronic Disease, run by Centre Hospitalier de Saint-Brieuc at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 11 years
Conditions the study is for
Cystic Fibrosis in Children, Chronic Disease
What is being tested?
Connected device named "Leo" from Ludocare society
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesFrance
Study dates
20 Jan 2021to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Marie JAMIN contact

+33296017818

marie.jamin@ch-stbrieuc.fr

Gwenaëlle LE GARFF contact

+33296017277

gwenaelle.legarff@armorsante.bzh

France2 sites, 2 recruiting

  • Chu Rennes

    Rennes, 35000

    Eric DENEUVILLE

    Not yet recruiting

  • Centre Hospitalier de Saint-Brieuc

    Saint-Brieuc, 22000

    Marie JAMIN

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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
Being tested
Connected device named "Leo" from Ludocare society
Keywords
Connected device, Long-term therapy, Pneumology, Adherence therapy, Pediatric research, Pediatric device support
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04705636
Study groupRoleWhat they receive
Connected deviceExperimentalConnected device for three months period to support children care
Receives: Device: Connected device named "Leo" from Ludocare society

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, up to 6 months

Secondary outcomes (16)

  1. 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)

    Measured: At the inclusion

  2. 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)

    Measured: At the inclusion

  3. Assess child's autonomy regarding his treatments

    Reporting in connected device

    Measured: 3 months

  4. Assess the intake treatments quality

    Questionnaire for parents on difficulties frequency with checked answers (no specific scale available)

    Measured: At the inclusion

  5. 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)

    Measured: 3 months

  6. 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)

    Measured: 4 to 6 months

  7. 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)

    Measured: at the inclusion

  8. 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)

    Measured: 3 months

  9. 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)

    Measured: 4 to 6 months

  10. 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)

    Measured: 3 months

  11. 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)

    Measured: 3 months

  12. Assess the intake treatments quality

    Questionnaire for parents on difficulties frequency with checked answers (no specific scale available)

    Measured: 3 months

  13. 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)

    Measured: 4 to 6 months

  14. 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)

    Measured: 4 to 6 months

  15. Assess child's autonomy regarding his treatments

    Reporting in connected device

    Measured: 4 to 6 months

  16. Assess the intake treatments quality

    Questionnaire for parents on difficulties frequency with checked answers (no specific scale available)

    Measured: 4 to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start20 Jan 2021
  3. Primary completionJun 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04705636
Sponsor's protocol ID
CHSB_202010_P3_COMPANION-CF
Other IDs
ID-RCB
Acronym
COMPANION-CF
Status last verified
Jan 2021
First submitted
14 Dec 2020
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14667488

  • 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.

    PubMed 19416142

  • 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.

    PubMed 16387243

  • 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.

    PubMed 8658364

  • 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.

    PubMed 18304896

  • 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.

    PubMed 27060726

  • 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.

    PubMed 25233386

  • 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.

    PubMed 28056541

Questions about this trial

What is this clinical trial studying?

A study testing Connected device named "Leo" from Ludocare society in people with Cystic Fibrosis in Children and Chronic Disease, run by Centre Hospitalier de Saint-Brieuc at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie JAMIN (+33296017818, marie.jamin@ch-stbrieuc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate therapeutic adherence of children with cystic fibrosis aged 3 to 11 years with help of a connected medical companion (time frame: Through study completion, up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04705636, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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