"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)
NCT ID: NCT07307950
Last Updated: 2025-12-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
20 participants
Study Classification
OBSERVATIONAL
Study Start Date
2026-01-05
Study Completion Date
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Context Chronic diseases are increasing, and healthcare is becoming more complex. Integrated care-that is, care that is coordinated, person-centered, and continuous-is essential to improve efficiency. In pediatric rehabilitation, coordination between the child, their family, and professionals working in hospitals, rehabilitation centers, integrated healthcare and social settings, outpatient settings, private practice is particularly critical. Effective coordination helps promote the child's participation in all areas of life and supports them through major life transitions, such as starting school or moving from adolescence to adulthood.
In this context, the digital application "Deneo Kid" was developed at the University Hospital of Brest through a partnership between the company Deneo, which already developed a shared portal for adult sports rehabilitation, and the BEaCHILD research team, specialized in child disability. It was designed based on qualitative studies exploring the needs of parents of children with disabilities (PitchRehab, supported by the Ildys Foundation), young people with disabilities (KidChildRehab, supported by the University Hospital of Brest), and professionals in rehabilitation, education, and leisure (ProChildRehab, supported by the University Hospital of Brest). "Deneo Kid" aims to connect children, their families, and rehabilitation professionals around a coordinated care and life plan centered on their needs, in order to promote integrated pediatric rehabilitation using a digital tool.
Funding from the Fondation de l'Avenir has been obtained to conduct a usability and impact study of the application. Additional funding has been requested from IReSP to explore the social determinants of adoption and the economic impact of the application with the support of a sociologist and a health economist from IMT Atlantique, as part of the same usability study.
To achieve this, the "Deneo Kid" application will be tested for 3 months with a cohort of users composed of 20 "teams," each including one child living with a neuromotor disability (cerebral palsy, neuromuscular disease, neurodevelopmental disease with motor impairments, etc.), their parents/legal guardians, and at least two rehabilitation professionals involved in their rehabilitation. Participants will be recruited from four pediatric rehabilitation centers in France. A mixed-methods approach will be used, including quantitative data collection and analysis (pre- and post-intervention questionnaires for users, anonymized application usage data collected via Deneo, and costs associated with coordination with and without the application) and qualitative data collection and analysis (interviews and focus groups before and after the study, digital journals, and direct observations).
This first small-scale experimental study will provide a better understanding of the usability, acceptability and impact of "Deneo Kid" across different pediatric rehabilitation settings and the factors contributing to its success. It will also provide a solid foundation for future larger-scale studies, contributing to improvements in the quality and efficiency of pediatric rehabilitation care.
Target Population The end users of the "Deneo Kid" digital solution include children and young people with disabilities aged 0-25 years, parents or legal guardians of these children, and rehabilitation professionals such as physicians, physiotherapists, occupational therapists, psychomotor therapists, psychologists, speech therapists, specialized educators, and adapted physical activity educators. The term "parents or family" is used throughout the text for simplicity but includes legal guardians.
Primary Objective The primary objective of this study is to evaluate the usability of the "Deneo Kid" application among the described user cohort.
Secondary Objectives
The secondary objectives of the study are:
1. To evaluate the use of the "Deneo Kid" application by all participants.
2. To assess the quality of the application from the perspective of all users.
3. To evaluate the impact of the application on the provision of integrated care from the perspective of families.
4. To assess the effect of the application on the implementation of family-centered care from the perspectives of both families and professionals.
5. To evaluate the acceptability of the application from the viewpoint of all participants.
6. To analyze the influence of the application on communication and relational dynamics among stakeholders.
7. To identify social determinants that affect the adoption of the application in different contexts.
8. To compare the time and costs of care coordination before and after using the application from the perspectives of families and professionals.
Primary Outcome Measure The primary outcome is usability, assessed using the System Usability Scale (SUS), completed by adolescents over 16, their parents, and the rehabilitation professionals who follow them.
Secondary Outcome Measures
1. Application use: Usage will be monitored through anonymized back-office data, including login times, average connection durations, and feature usage over the three months.
2. Application quality: Quality will be assessed using the validated Mobile Application Rating Scale (MARS) for young adults, families, and professionals after three months of use.
3. Integrated care: Families will complete the Pediatric Integrated Care Survey (PICS) before and after three months to evaluate the impact on integrated care.
4. Family-centered care: Families will complete the Measure of Processes of Care (MPOC) questionnaires, and professionals will complete the MPOC-Service Providers (MPOC-SP) questionnaire before and after three months to assess family-centered care practices.
5. Acceptability: Acceptability will be evaluated through the questionnaire Theoretical Framework Acceptability and through interviews or focus groups with adolescents, parents, and professionals conducted in person or via videoconference.
6. Relational dynamics and communication: interviews and observations on site will assess communication and relationships among participants.
7. Social determinants of adoption: Socio-demographic data collected before the study will be analyzed to identify factors affecting adoption.
8. Time and coordination costs: Direct costs (Deneo subscription) and indirect costs (time spent using the application) will be collected via application usage statistics and coordination practice questionnaires before and after the study.
Methodology This is a multicenter, prospective observational study evaluating professional practices using a mixed-methods design with quantitative and qualitative data across 20 child-family-professional teams.
Statistics Each participant will be assigned a pseudonym, and only the principal investigators will have access to the key linking names to pseudonyms. Quantitative data will be stored on a secure server in Excel files and analyzed descriptively, reporting frequencies, means with standard deviations, or medians with interquartile ranges depending on the data type. The primary criterion of usability considers a mean SUS score above 51 as acceptable.
Qualitative data from interviews and focus groups will be recorded using Zebrix, a local secure platform of the university hospital of Brest, and transcribed verbatim using AI. Analysis will follow the six-phase thematic analysis method of Braun \& Clarke (2016) using NVivo14 software.
Inclusion Criteria Children and young people aged 0-25 with a physical disability (such as acquired brain injury, musculoskeletal disorders, rare diseases, congenital heart conditions) causing participation limitations according to the International Classification of Functioning, Disability and Health (WHO, 2007), who are followed in rehabilitation at least once per week by at least two professionals in different sectors with the goal of promoting autonomy and participation. Parents or legal guardians must have access to a computer, smartphone, or tablet. Rehabilitation professionals must work with children with disabilities and have access to digital devices.
Exclusion Criteria Refusal to participate.
Number of Participants The study aims to include 20 children/young people, their parents, and at least two rehabilitation professionals per child. The total number of participants using the application for three months is expected to be between 80 and 100.
Timeline Enrollment will take place over 12 months. Each participant will use the application for three months, between November 2025 and June 2026. The total study duration, including enrollment and follow-up, is 12 months, with data collection and processing expected to take 18 months.
In this context, the digital application "Deneo Kid" was developed at the University Hospital of Brest through a partnership between the company Deneo, which already developed a shared portal for adult sports rehabilitation, and the BEaCHILD research team, specialized in child disability. It was designed based on qualitative studies exploring the needs of parents of children with disabilities (PitchRehab, supported by the Ildys Foundation), young people with disabilities (KidChildRehab, supported by the University Hospital of Brest), and professionals in rehabilitation, education, and leisure (ProChildRehab, supported by the University Hospital of Brest). "Deneo Kid" aims to connect children, their families, and rehabilitation professionals around a coordinated care and life plan centered on their needs, in order to promote integrated pediatric rehabilitation using a digital tool.
Funding from the Fondation de l'Avenir has been obtained to conduct a usability and impact study of the application. Additional funding has been requested from IReSP to explore the social determinants of adoption and the economic impact of the application with the support of a sociologist and a health economist from IMT Atlantique, as part of the same usability study.
To achieve this, the "Deneo Kid" application will be tested for 3 months with a cohort of users composed of 20 "teams," each including one child living with a neuromotor disability (cerebral palsy, neuromuscular disease, neurodevelopmental disease with motor impairments, etc.), their parents/legal guardians, and at least two rehabilitation professionals involved in their rehabilitation. Participants will be recruited from four pediatric rehabilitation centers in France. A mixed-methods approach will be used, including quantitative data collection and analysis (pre- and post-intervention questionnaires for users, anonymized application usage data collected via Deneo, and costs associated with coordination with and without the application) and qualitative data collection and analysis (interviews and focus groups before and after the study, digital journals, and direct observations).
This first small-scale experimental study will provide a better understanding of the usability, acceptability and impact of "Deneo Kid" across different pediatric rehabilitation settings and the factors contributing to its success. It will also provide a solid foundation for future larger-scale studies, contributing to improvements in the quality and efficiency of pediatric rehabilitation care.
Target Population The end users of the "Deneo Kid" digital solution include children and young people with disabilities aged 0-25 years, parents or legal guardians of these children, and rehabilitation professionals such as physicians, physiotherapists, occupational therapists, psychomotor therapists, psychologists, speech therapists, specialized educators, and adapted physical activity educators. The term "parents or family" is used throughout the text for simplicity but includes legal guardians.
Primary Objective The primary objective of this study is to evaluate the usability of the "Deneo Kid" application among the described user cohort.
Secondary Objectives
The secondary objectives of the study are:
1. To evaluate the use of the "Deneo Kid" application by all participants.
2. To assess the quality of the application from the perspective of all users.
3. To evaluate the impact of the application on the provision of integrated care from the perspective of families.
4. To assess the effect of the application on the implementation of family-centered care from the perspectives of both families and professionals.
5. To evaluate the acceptability of the application from the viewpoint of all participants.
6. To analyze the influence of the application on communication and relational dynamics among stakeholders.
7. To identify social determinants that affect the adoption of the application in different contexts.
8. To compare the time and costs of care coordination before and after using the application from the perspectives of families and professionals.
Primary Outcome Measure The primary outcome is usability, assessed using the System Usability Scale (SUS), completed by adolescents over 16, their parents, and the rehabilitation professionals who follow them.
Secondary Outcome Measures
1. Application use: Usage will be monitored through anonymized back-office data, including login times, average connection durations, and feature usage over the three months.
2. Application quality: Quality will be assessed using the validated Mobile Application Rating Scale (MARS) for young adults, families, and professionals after three months of use.
3. Integrated care: Families will complete the Pediatric Integrated Care Survey (PICS) before and after three months to evaluate the impact on integrated care.
4. Family-centered care: Families will complete the Measure of Processes of Care (MPOC) questionnaires, and professionals will complete the MPOC-Service Providers (MPOC-SP) questionnaire before and after three months to assess family-centered care practices.
5. Acceptability: Acceptability will be evaluated through the questionnaire Theoretical Framework Acceptability and through interviews or focus groups with adolescents, parents, and professionals conducted in person or via videoconference.
6. Relational dynamics and communication: interviews and observations on site will assess communication and relationships among participants.
7. Social determinants of adoption: Socio-demographic data collected before the study will be analyzed to identify factors affecting adoption.
8. Time and coordination costs: Direct costs (Deneo subscription) and indirect costs (time spent using the application) will be collected via application usage statistics and coordination practice questionnaires before and after the study.
Methodology This is a multicenter, prospective observational study evaluating professional practices using a mixed-methods design with quantitative and qualitative data across 20 child-family-professional teams.
Statistics Each participant will be assigned a pseudonym, and only the principal investigators will have access to the key linking names to pseudonyms. Quantitative data will be stored on a secure server in Excel files and analyzed descriptively, reporting frequencies, means with standard deviations, or medians with interquartile ranges depending on the data type. The primary criterion of usability considers a mean SUS score above 51 as acceptable.
Qualitative data from interviews and focus groups will be recorded using Zebrix, a local secure platform of the university hospital of Brest, and transcribed verbatim using AI. Analysis will follow the six-phase thematic analysis method of Braun \& Clarke (2016) using NVivo14 software.
Inclusion Criteria Children and young people aged 0-25 with a physical disability (such as acquired brain injury, musculoskeletal disorders, rare diseases, congenital heart conditions) causing participation limitations according to the International Classification of Functioning, Disability and Health (WHO, 2007), who are followed in rehabilitation at least once per week by at least two professionals in different sectors with the goal of promoting autonomy and participation. Parents or legal guardians must have access to a computer, smartphone, or tablet. Rehabilitation professionals must work with children with disabilities and have access to digital devices.
Exclusion Criteria Refusal to participate.
Number of Participants The study aims to include 20 children/young people, their parents, and at least two rehabilitation professionals per child. The total number of participants using the application for three months is expected to be between 80 and 100.
Timeline Enrollment will take place over 12 months. Each participant will use the application for three months, between November 2025 and June 2026. The total study duration, including enrollment and follow-up, is 12 months, with data collection and processing expected to take 18 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Children and Adolescents With Neuromotor Impairment
Children and Youth With Special Healthcare Needs
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* Refusal to participate.
Minimum Eligible Age
2 Years
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Brest
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marietta KERSALE
OT, MSc, PhD student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chu Brest
Brest, , France
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
France
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Marietta Kersalé, OT, MSc, PhD student
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Related Links
Access external resources that provide additional context or updates about the study.
https://beachild.fr/
Related Info
https://deneo.fr/
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
29BRC25.0043 - HAPPY
Identifier Type: -
Identifier Source: org_study_id