Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570148
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Stakeholder Perspectives on the Need for a Digital Solution in Pediatric Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Towards the Development of a Digital Solution to Support the Exchange of Information in Paediatric Rehabilitation an Exploratory Qualitative Study With Professionals Decision-makers and Patients Concerned ProKidChildRehab
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProChRehab
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 them rehabilitation education leisure for monitoring childrens 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 its 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
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 them rehabilitation education leisure for monitoring childrens 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 its 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
Detailed Description:
In France around 3 million children are carriers of a chronic disease These children require individualized highly specialized rehabilitation care supported by interdisciplinary teams often over many years Rehabilitation is defined as a set of interventions designed to optimize the functioning and reduce the disability of people with health problems as they interact with their environment WHO 2017 The main objective of rehabilitation is thus to promote the childs social participation in his or her daily life whether at home school or leisure To achieve this goal the partnership between all the professionals involved with the child the child and his or her family is essential The exchange of information between these stakeholders must be optimal throughout the childs care However there are many gaps in access to and sharing of information around the child due to the multiplicity of stakeholders involved the constant changes care structures school etc and the wide variety of contexts school home private practice leisure hospital E-health or digital health presents multiple opportunities to promote access to information improve monitoring of children involve the family in care and reduce the mental burden associated with information exchanges which are mainly handled by the family The Deneo KID project led by WInn Brest University Hospitals innovation center and carried out in partnership with the Deneo company aims to meet these challenges It aims to develop a digital solution for exchanging information between the various players involved in the childs care This study is therefore directly in line with the Deneo KID project
Indeed it is recognized in the literature that taking into account the needs and expectations of users families professionals children from the earliest design phases of a digital solution is essential to foster its usability acceptability and future appropriation by its users Andersen et al 2014 But this is not enough and the literature shows a high percentage of failure in digital health innovation projects Bird et al 2019 For a solution to be adopted by its users it is also essential to take into account the obstacles and brakes to the implementation of this type of solution at different levels professionals decision-makers Van Gemert-Pijnen et al 2011 Indeed authors have highlighted organizational factors likely to hinder or support the adoption of this type of solution such as organizational support or the persuasive strategies and techniques implemented by the organization to encourage the adoption of a solution by the professionals on a team Van Gemert-Pijnen et al 2011 Whitelaw et al 2021 Borges do Nascimento et al 2023
Considering these elements we have chosen to include not only people concerned by the use of the solution but also people empowered to lead change ie decision-makers in settings welcoming children with chronic health conditions We will define decision-makers as those involved in decision-making concerning the implementation of digital solutions in the various structures working for the health of children with chronic health conditions They may be health managers or senior health managers in hospitals and rehabilitation centers directors or heads of department in medico-social establishments or association leaders This will enable us to work with decision-makers to define appropriate implementation strategies to encourage adoption of the solution in care environments and thus guarantee the success of the Deneo KID project
A qualitative focus group study of families of children with chronic illnesses was already carried out in 2022 supported by the Ildys Foundation PITChREHAB study Its aim was to explore the needs and expectations of families of children with chronic illnesses with regard to digital solutions to promote the exchange of information related to their childs rehabilitation This study highlighted multiple opportunities for families as well as essential functionalities to be included in the future Deneo KID solution from the families point of view
The ProChildRehab study is the second stage in the development of the Deneo KID solution It focuses on the needs of child-facing professionals and decision-makers for a digital solution designed to facilitate the exchange of information about children with disabilities
The ProChildRehab study is the second stage in the development of the Deneo KID solution It focuses on the needs of professionals working with children and decision-makers for a digital solution designed to facilitate the exchange of information about children with disabilities
The ProChildRehab study was approved by the CHU de Brest territory ethics committee on 14032024 Since then interviews have been carried out with 18 health education and leisure professionals working with children with disabilities psychologist PRM doctor specialist teacher AESH Handisport leader etc and 6 decision-makers health executive SESSAD director Handisport manager etc Further interviews are planned as data saturation has not yet been reached there is some redundancy in the answers but new ideas are still being contributed Analysis of these interviews is underway an iterative process in qualitative research with analysis concurrent with data collection Initial results suggest that the views of patients concerned by this future digital solution should be taken into account Indeed there is no consensus on several points such as the psychological information that could be shared by the child and his parents with professionals via the platform eg the childs morale the fact of sharing photos of daily life and therefore quite intimate eg photos of the house the usefulness of proposing self-rehabilitation exercises to patients via the platform rehabilitation overload for children vs ensuring continuity of services or the perception of what the childs reality is eg professionals who ask for more information on the childs reality to better support himher vs other professionals who say that this information is confidential We would therefore like to explore with young people the acceptability of certain features particularly in terms of the information that is acceptable for them to exchange about their health via this platform We would now like to question the people who could be concerned by the sharing of information through this future solution ie young people with disabilities who are living or have lived through the care of a child with a disability
These initial data obtained and the need to go out and interview patients corroborate with the literature on the subject which highlights the gaps between patients and clinicians perceptions of their needs and interests with regard to e-health and advocates an alignment of concerns on both sides Andersen et al 2014
Indeed it is recognized in the literature that taking into account the needs and expectations of users families professionals children from the earliest design phases of a digital solution is essential to foster its usability acceptability and future appropriation by its users Andersen et al 2014 But this is not enough and the literature shows a high percentage of failure in digital health innovation projects Bird et al 2019 For a solution to be adopted by its users it is also essential to take into account the obstacles and brakes to the implementation of this type of solution at different levels professionals decision-makers Van Gemert-Pijnen et al 2011 Indeed authors have highlighted organizational factors likely to hinder or support the adoption of this type of solution such as organizational support or the persuasive strategies and techniques implemented by the organization to encourage the adoption of a solution by the professionals on a team Van Gemert-Pijnen et al 2011 Whitelaw et al 2021 Borges do Nascimento et al 2023
Considering these elements we have chosen to include not only people concerned by the use of the solution but also people empowered to lead change ie decision-makers in settings welcoming children with chronic health conditions We will define decision-makers as those involved in decision-making concerning the implementation of digital solutions in the various structures working for the health of children with chronic health conditions They may be health managers or senior health managers in hospitals and rehabilitation centers directors or heads of department in medico-social establishments or association leaders This will enable us to work with decision-makers to define appropriate implementation strategies to encourage adoption of the solution in care environments and thus guarantee the success of the Deneo KID project
A qualitative focus group study of families of children with chronic illnesses was already carried out in 2022 supported by the Ildys Foundation PITChREHAB study Its aim was to explore the needs and expectations of families of children with chronic illnesses with regard to digital solutions to promote the exchange of information related to their childs rehabilitation This study highlighted multiple opportunities for families as well as essential functionalities to be included in the future Deneo KID solution from the families point of view
The ProChildRehab study is the second stage in the development of the Deneo KID solution It focuses on the needs of child-facing professionals and decision-makers for a digital solution designed to facilitate the exchange of information about children with disabilities
The ProChildRehab study is the second stage in the development of the Deneo KID solution It focuses on the needs of professionals working with children and decision-makers for a digital solution designed to facilitate the exchange of information about children with disabilities
The ProChildRehab study was approved by the CHU de Brest territory ethics committee on 14032024 Since then interviews have been carried out with 18 health education and leisure professionals working with children with disabilities psychologist PRM doctor specialist teacher AESH Handisport leader etc and 6 decision-makers health executive SESSAD director Handisport manager etc Further interviews are planned as data saturation has not yet been reached there is some redundancy in the answers but new ideas are still being contributed Analysis of these interviews is underway an iterative process in qualitative research with analysis concurrent with data collection Initial results suggest that the views of patients concerned by this future digital solution should be taken into account Indeed there is no consensus on several points such as the psychological information that could be shared by the child and his parents with professionals via the platform eg the childs morale the fact of sharing photos of daily life and therefore quite intimate eg photos of the house the usefulness of proposing self-rehabilitation exercises to patients via the platform rehabilitation overload for children vs ensuring continuity of services or the perception of what the childs reality is eg professionals who ask for more information on the childs reality to better support himher vs other professionals who say that this information is confidential We would therefore like to explore with young people the acceptability of certain features particularly in terms of the information that is acceptable for them to exchange about their health via this platform We would now like to question the people who could be concerned by the sharing of information through this future solution ie young people with disabilities who are living or have lived through the care of a child with a disability
These initial data obtained and the need to go out and interview patients corroborate with the literature on the subject which highlights the gaps between patients and clinicians perceptions of their needs and interests with regard to e-health and advocates an alignment of concerns on both sides Andersen et al 2014
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None