NCT06570148

Brief Summary

Introduction: Children with chronic conditions receive fragmented rehabilitative care due to the multitude of providers and structures involved, and the constant changes throughout their care and life course. E-health holds promise for supporting exchanges around the child and thus fostering more integrated care, but its adoption remains limited in healthcare settings. Objective : the aim of this project is to explore the issues related to the usefulness and acceptability of a digital platform shared between children, their families and the professionals working with the children (rehabilitation, education, leisure) for monitoring children's health, to identify needs and preoccupations from the perspectives of the futur users, to inform the development of a digital application, named Deneo Kid. Methodology: a qualitative study will be conducted. Semi-structured interviews will be conducted with professionals from the rehabilitation, education, social and leisure sectors in France, as well as decision-makers (healthcare executives, facility directors), and disabled children aged 11 to 25, to explore the opportunities, needs and concerns of these potential users with regard to this type of digital solution. The interviews will be conducted and recorded on Zoom. Only the audio recording will be kept, transcribed verbatim and then destroyed. At least 30 participants will be included, but it's when saturation is reached that the number of participants to be included will be determined. For the analysis, the 6 phases of a reflexive thematic analysis will be monitored using Nvivo12 software, by three analysts. The final themes will inform the development of a future digital health technology.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

March 22, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

October 31, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

August 20, 2024

Last Update Submit

October 29, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • List of needs for the future app : list of needs expressed by professionals, decision-makers and patients with regard to priority information exchanges via digital solutions

    This outcome will be collected qualitatively, using open-ended questions asked during a semi-structured individual interview with each participant. Their needs will be explored using open-ended and follow-up questions (e.g.: what are your needs for information exchange with the family? with the child? with other professionals? how could a digital solution facilitate these exchanges?) A qualitative analysis (inductive) will help to meet this outcome

    24 months

  • List of facilitators and barriers of the app adoption : List of facilitators and barriers of digital health technology adoption among health professionals, decision makers and patients

    This outcome will be collected qualitatively, using open-ended questions asked during a semi-structured individual interview with each participant. Their needs will be explored using open-ended and follow-up questions (e.g.: what concerns do you have about using a digital solution to communicate with the family? with the child? with other professionals? what do you think would facilitate adoption of the solution in your environment?) A hybrid qualitative analysis (inductive and deductive using an implementation science model such as the CFIR, Damschroder et al., 2022 will help to meet this outcome)

    24 months

  • List of strategies to implement the app : List of strategies to implement digital health technology in a pediatric rehabilitation context, from the perspectives of different end users

    This outcome will be collected qualitatively, using open-ended questions asked during a semi-structured individual interview with each participant. Their needs will be explored using open-ended questions and follow-up questions (e.g.: what would be the key determinants for such a solution to be implemented in your area? What strategies at micro/meso/macro level?) A hybrid qualitative analysis (inductive and deductive using an implementation science model such as the CFIR, Damschroder et al., 2022 will help to meet this outcome)

    24 months

Interventions

Participants will be recruited using purposive sampling with maximum variation. If they meet the inclusion criteria, they will be invited to take part in an online interview or focus group, lasting between 40 minutes and 1.5 hours. During the Zoom interview or focus group, they will be asked to answer several pre-defined open-ended questions based on an interview grid co-constructed with the co-investigators, including a patient partner and parent partners. They will be asked to answer closed socio-demographic questions at the end of the interview or focus group. The Zoom meeting will be recorded (audio) and then transcribed into anonymized written form.

Eligibility Criteria

Age11 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Professionals: a health, social, educational or leisure professional involved in the rehabilitation of children with disabilities (doctor, physiotherapist, occupational therapist, kinesiologist, psychomotor therapist, speech therapist, psychologist, specialized educator, social worker, school nurse, sports educator in a leisure center,...) Decision-makers: a professional working in the health or social field and managing or coordinating a team of rehabilitation professionals working in pediatrics (clinical coordinator, health executive, senior health executive, clinical expert, director of a medico-social establishment, etc.), or a leisure structure for children with disabilities,...) Patients: young people aged 11 to 25 living with a disability

You may qualify if:

  • Be a health, social, educational or leisure professional involved in the rehabilitation of children with disabilities (doctor, physiotherapist, occupational therapist, kinesiologist, psychomotor therapist, speech therapist, psychologist, specialized educator, social worker, school nurse, sports educator in a leisure center, nursery assistant in a crèche, etc.).
  • Speak and understand French
  • DECISION MAKERS
  • Be a professional working in the health or social field and managing or coordinating a team of rehabilitation professionals working in pediatrics (clinical coordinator, health executive, senior health executive, clinical expert, director of a medico-social establishment, etc.), or a leisure structure for children with disabilities, or a crèche for children with disabilities.
  • Speak and understand French
  • PATIENTS
  • be between the ages of 11 and 25
  • have had a disability as defined by the International Classification of Functioning and Disability (ICF) since childhood
  • have undergone or be undergoing paediatric rehabilitation care
  • have been followed or be followed by at least 3 different rehabilitation, school or leisure professionals (e.g. private physiotherapist, APA Handisport, specialized school teacher, etc.)
  • have good oral communication skills

You may not qualify if:

  • \- communication difficulties (e.g. aphasia) or intellectual deficiencies that make it impossible to express oneself during an interview lasting about 1 hour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

Related Publications (1)

  • Kersale M, Hong QN, Richard T, Kandalaft Cabrol C, Guevel A, Fily E, Tisserand G, Brochard S, Pomey MP, Pons C. Perspectives From Multidisciplinary Professionals in France on Shared Patient Portals for Integrated Pediatric Rehabilitation: Qualitative Study. JMIR Rehabil Assist Technol. 2025 Oct 10;12:e73068. doi: 10.2196/73068.

MeSH Terms

Conditions

Developmental Disabilities

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marietta Kersalé

    CHU de Brest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marietta Kersalé, MSc

CONTACT

Christelle Pons, MCU-PH, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 26, 2024

Study Start

March 22, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

October 31, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations