"Healthcare APPlication for Children and Young People With Neuromotor Disabilities": a Digital Tool to Promote Integrated Pediatric Rehabilitation Care for Children and Young People With Disabilities and Their Families: a Mixed-methods Usability-acceptability-impact Study (HAPPY)

NCT07307950 | Recruiting

• 1 other identifier: 29BRC25.0043 - HAPPY
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational multicentric mixed methods study is to evaluate if the digital application "Deneo Kid", co-designed in France with adolescents, families, rehabilitation providers and researchers, can improve the coordination and quality of rehabilitation care for children and young people with neuromotor disabilities. The main questions it aims to answer are whether the application is easy to use for children, their families, and rehabilitation professionals, is acceptable, whether it helps families and professionals provide more integrated, including more family-centered and coordinated care, and whether it affects communication, relationships, and time and costs related to care coordination. Rehabilitation providers, families and adolescents ≥ 16 years old will use the "Deneo Kid" secured application for 3 months to share information, track care goals, and communicate with the rehabilitation care team. They will complete short surveys before and after using the application to report on usability, acceptability, quality, and the impact on rehabilitation care. Participants will also take part in interviews or focus groups to share their experiences with the application. The study will include 20 children, adolescents and young people aged 2 to 25 years living with neuromotor disabilities, followed-up in rehabilitation, their parents or legal guardians, and at least two rehabilitation professionals per child. Four rehabilitation centers in France will participate to the study. Researchers will observe how the application is used in these different rehabilitation settings and collect information on usability, care coordination, user experience, and the time and cost involved in managing care. The results will help determine whether "Deneo Kid" could support better coordination and family-centered rehabilitation for children and young people with disabilities and provide a foundation for larger future studies, to evaluate the effectiveness of the application.

Conditions

Children and Adolescents With Neuromotor Impairment; Children and Youth With Special Healthcare Needs

Outcome Measures

Primary Outcomes (1)

• Usability of the app

  Usability of the "Deneo Kid" application from the perspective of all end-users (adolescents, families, professionals)

  from enrollment (beginning of use of the app) to the end of the application test at 3 months

Secondary Outcomes (2)

• Acceptability

  From enrollment (beginning of the use of the app) to the end of the use of the app at 3 months

• Impact on integrated care

  From enrollment (beginning of the use of the app) to the end of the use of the app at 3 months

Study Arms (1)

Cohort of children followed-up in rehabilitation

Group of 20 children living with neuromotor impairments followed-up in paediatric rehabilitation, with their parents and at least 2 rehabilitation professional per child.

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with neuromotor impairments followed up in four paediatric rehabilitation settings in France: healthcare, integrated health and social care, and outpatient/private practice settings.

You may qualify if:

• Aged 2 to 25 years.
• Presenting a neuromotor impairment (such as cerebral palsy, acquired brain injury, musculoskeletal disorders, rare diseases, congenital heart conditions,...) that results in limitations in participation, according to the International Classification of Functioning, Disability and Health (ICF, WHO 2007).
• Receiving rehabilitation at least once per week from at least two professionals in different care settings (e.g., healthcare, integrated health and social care, and outpatient settings) with a focus on promoting autonomy and participation.
• Being the parent or legal guardian of a child meeting the criteria above.
• Having access to a computer, smartphone, or tablet.
• Working with children with disabilities in pediatric rehabilitation (including physicians, physiotherapists, occupational therapists, psychomotor therapists, psychologists, speech therapists, specialized educators, or adapted physical activity educators).
• Practicing in healthcare, integrated health and social care, or outpatient/private practice settings.
• having access to a computer, smartphone, or tablet.

You may not qualify if:

• Refusal to participate.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

Related Publications (4)

• Cornec G, Drewnowski G, Desguerre I, Toullet P, Boivin J, Bodoria M, De La Cruz J, Brochard S; ESPaCe group. Determinants of satisfaction with motor rehabilitation in people with cerebral palsy: A national survey in France (ESPaCe). Ann Phys Rehabil Med. 2021 May;64(3):101314. doi: 10.1016/j.rehab.2019.09.002. Epub 2019 Oct 3.

  PMID: 31586683 RESULT

• Ziniel SI, Rosenberg HN, Bach AM, Singer SJ, Antonelli RC. Validation of a Parent-Reported Experience Measure of Integrated Care. Pediatrics. 2016 Dec;138(6):e20160676. doi: 10.1542/peds.2016-0676.

  PMID: 27940672 RESULT

• Cassidy L, Quirke MB, Alexander D, Greene J, Hill K, Connolly M, Brenner M. Integrated care for children living with complex care needs: an evolutionary concept analysis. Eur J Pediatr. 2023 Apr;182(4):1517-1532. doi: 10.1007/s00431-023-04851-2. Epub 2023 Feb 13.

  PMID: 36780041 RESULT

• Rosenbaum P, Gorter JW. The 'F-words' in childhood disability: I swear this is how we should think! Child Care Health Dev. 2012 Jul;38(4):457-63. doi: 10.1111/j.1365-2214.2011.01338.x. Epub 2011 Nov 1.

  PMID: 22040377 RESULT

Related Links

• Related Info
• Related Info

Central Study Contacts

Marietta Kersalé, OT, MSc, PhD student

CONTACT

+33633498971; marietta.kersale@chu-brest.fr

Christelle Pons-Becmeur, MD, PhD

CONTACT

0298223373; christelle.pons@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OT, MSc, PhD student

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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

FR (1)