Impact of the "Kid'EM App" Digital Guidance Tool for Setting Rehabilitation Goals by the Rehabilitation Professional for Children with Chronic Conditions Impacting Physical Health (READ'APP'T)

NCT ID: NCT06475950

Last Updated: 2025-02-05

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-04-01

Brief Summary

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On an individual level, the first expected benefit for the child using the "Kid'EM app" would be an improvement in the quality of his or her rehabilitation goals, which would be more Specific, Measurable, Activity-related, Realistic and Time-defined (SMART). A second expected benefit for the child, thanks to the work carried out in rehabilitation sessions on objectives adapted to his or her needs and day-to-day life, encouraging commitment and motivation, would be to improve the effectiveness of the care offered to him or her, thereby enhancing autonomy and physical health. For parents, taking part in goal-setting, by contributing their knowledge of their child and his or her daily life, would increase their involvement in their child's care and improve their satisfaction with the care offered. By setting SMART functional goals and facilitating communication between therapist, child and family, we expect to see a more child- and family-centred approach to care.

On a collective level, the "Kid'EM app" proposal would, as recommended by the WHO, improve professional rehabilitation practices and facilitate convergence towards good clinical practices for professionals (physiotherapists, occupational therapists, PRMs, etc.), thereby increasing the efficiency of the child rehabilitation care system.

If its value is demonstrated, the Kid'EM app could be adapted for children with other chronic illnesses requiring non-motor rehabilitation follow-up. The digitization of this goal-setting tool means that this low-cost practice could be widely disseminated.

Detailed Description

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Conditions

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Children with Chronic Illnesses Affecting Physical Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

"Kid'EM app" experimental group

Rehabilitation professionals have access to the Kid'EM app tool, which guides them in setting goals.

The app offers functionalities, including the selection of avatars by children, the identification of children's tastes and needs, the definition of SMART objectives, and the setting up of exchange spaces with parents and other professionals.

The application enables the identification of environmental elements that may impact on the child's progress, and provides a note-taking space for the professional.

Kidem app control group

Rehabilitation professionals have access to a control application which has the same design, but does not offer guidance or a space for exchange with parents.

The functionalities of the control application include the creation of the professional's account, selecting the child's pathology, identifying the child's tastes, and entering objectives without guidance.

Professionals use their usual strategy to set goals."
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

The process of setting rehabilitation goals with "Kid'EM app" requires collaboration between the professional, the child and the family, preventing rehabilitation professionals and children and their families from being blindsided.

Study Groups

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Kid'EM app" experimental group

This group uses the Kid'EM app, which guides rehabilitation professionals in setting goals for each child. The app offers a variety of features, including the creation of patient accounts and records, identification of the child's likes and needs, definition of SMART goals, and spaces for exchanges with parents and other professionals. Parents also have access to the application.

Group Type ACTIVE_COMPARATOR

Kid'EM app" experimental group

Intervention Type OTHER

In the "Kid'EM app" experimental group arm, only the application used differs. Visits are organized in the same way as in the controle app arm.

Visit 0 (Inclusion) + Visit 1 (V1) : Physical visit

Children are included in the study by the investigator, formalized by signing a consent form.

Parents fill in questionnaires

Visit 2 (when 1st objective is set):

Telephone interview to assess performance and satisfaction levels after the first goal has been set.

Visit 3 (when setting the 2nd goal):

Telephone interview to assess performance and satisfaction levels after the second goal has been set.

Visit 4 (week 14 - end of study): Physical visit

The questionnaires are again completed by the parents, either directly on a tablet or on paper for later input.

Visit 4 bis:

Telephone interview to assess performance and satisfaction levels after the work on the first two objectives.

Visit 5 (focus group, optional post-study visit)

Kidem app control group

This group uses a control app that offers no guidance or space for exchange with parents. Professionals use their usual strategy to set goals. The functionalities of the control app are more limited, focusing on creating the professional's account, filling in the first letter of the child's first and last name, selecting the child's pathology, identifying the child's tastes, and filling in the objectives without guidance.

Group Type SHAM_COMPARATOR

Kid'EM app control group

Intervention Type OTHER

Use of control application without guidance for goal setting

Visit 0 (Inclusion) + Visit 1 (V1) : Physical visit

Children are included in the study by the investigator, formalized by signing a consent form.

Parents fill in questionnaires

Visit 2 (when 1st objective is set):

Telephone interview to assess performance and satisfaction levels after the first goal has been set.

Visit 3 (when setting the 2nd goal):

Telephone interview to assess performance and satisfaction levels after the second goal has been set.

Visit 4 (week 14 - end of study): Physical visit

The questionnaires are again completed by the parents, either directly on a tablet or on paper for later input.

Visit 4 bis:

Telephone interview to assess performance and satisfaction levels after the work on the first two objectives.

Visit 5 (focus group, optional post-study visit)

Interventions

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Kid'EM app" experimental group

In the "Kid'EM app" experimental group arm, only the application used differs. Visits are organized in the same way as in the controle app arm.

Visit 0 (Inclusion) + Visit 1 (V1) : Physical visit

Children are included in the study by the investigator, formalized by signing a consent form.

Parents fill in questionnaires

Visit 2 (when 1st objective is set):

Telephone interview to assess performance and satisfaction levels after the first goal has been set.

Visit 3 (when setting the 2nd goal):

Telephone interview to assess performance and satisfaction levels after the second goal has been set.

Visit 4 (week 14 - end of study): Physical visit

The questionnaires are again completed by the parents, either directly on a tablet or on paper for later input.

Visit 4 bis:

Telephone interview to assess performance and satisfaction levels after the work on the first two objectives.

Visit 5 (focus group, optional post-study visit)

Intervention Type OTHER

Kid'EM app control group

Use of control application without guidance for goal setting

Visit 0 (Inclusion) + Visit 1 (V1) : Physical visit

Children are included in the study by the investigator, formalized by signing a consent form.

Parents fill in questionnaires

Visit 2 (when 1st objective is set):

Telephone interview to assess performance and satisfaction levels after the first goal has been set.

Visit 3 (when setting the 2nd goal):

Telephone interview to assess performance and satisfaction levels after the second goal has been set.

Visit 4 (week 14 - end of study): Physical visit

The questionnaires are again completed by the parents, either directly on a tablet or on paper for later input.

Visit 4 bis:

Telephone interview to assess performance and satisfaction levels after the work on the first two objectives.

Visit 5 (focus group, optional post-study visit)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with chronic illnesses affecting their physical health (e.g. Cerebral Palsy, Neuromuscular Disease, Brachial Plexus Paralysis, etc.).
* Children receiving rehabilitation care to promote autonomy and physical health.
* Child with at least one rehabilitation session/week with the same professional for a period of 3 months
* Children aged 5 to 17 wishing to participate in the study
* Parental consent for study participation and signature of consent form

Exclusion Criteria

* Children without chronic illnesses that do not affect their physical health
* Children unable to express their views and priorities
* Children unable to collaborate with the rehabilitation professional when using the Kid'EM app
* Children already familiar with the "Kid'EM app" product
* Children whose parents are minors or unable to give informed consent
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ildys Ty Yann

Angers, , France

Site Status

Les Capucins Angers

Angers, , France

Site Status

IEM Galaxie

Argeles, , France

Site Status

SESSAD 93 - Aulnay

Aulnay-sous-Bois, , France

Site Status

SESSAD APF Basse Goulaine

Basse-Goulaine, , France

Site Status

SMR Concarneau

Concarneau, , France

Site Status

Dispositif sensoriel et moteur Clos Chauveau - DIJON

Dijon, , France

Site Status

Sessad APF France Handicap du Finistère

Gouesnou, , France

Site Status

CAMSP APF Grenoble

Grenoble, , France

Site Status

Cabinet de Kinésithérapie - Elodie CREACH

Landerneau, , France

Site Status

SESSAD 93-Raincy

Le Raincy, , France

Site Status

Cabinet d'Ergothérapie - Maison des Korrigans

Lesneven, , France

Site Status

SESSAD A Denn Askell - KERPAPE

Lorient, , France

Site Status

CAMSP Nelson Mandela

Lyon, , France

Site Status

CAPEDIA

Lyon, , France

Site Status

CMCR Les Massues

Lyon, , France

Site Status

CMRP Romans Ferrari - Service Brulologie

Miribel, , France

Site Status

CMRP Romans Ferrari - Service Neurologie

Miribel, , France

Site Status

IEM La Marrière

Nantes, , France

Site Status

CHU Carémeau

Nîmes, , France

Site Status

Cabinet Jaures Kiné

Nîmes, , France

Site Status

Cabinet Sophie CHAPELLIER

Nîmes, , France

Site Status

IEM La Cigale

Nîmes, , France

Site Status

SESSAD La Cigale

Nîmes, , France

Site Status

IEM Ar Menn

Ploemeur, , France

Site Status

Centre Paul DOTTIN

Ramonville-Saint-Agne, , France

Site Status

SESSAD Henri Matisse

Rennes, , France

Site Status

SESSAD Romans

Romans-sur-Isère, , France

Site Status

SMR pédiatrique ILDYS

Roscoff, , France

Site Status

SESSAD Saint Etienne

Saint-Etienne, , France

Site Status

CHU Saint Etienne - MPR Pédiatrique

Saint-Etienne, , France

Site Status

CMPR Côte d'Amour

Saint-Nazaire, , France

Site Status

Centre de l'Arche

Saint-Saturnin, , France

Site Status

UGECAM Strasbourg

Strasbourg, , France

Site Status

SMR Vannes - Centre hospitalier bretagne atlantique

Vannes, , France

Site Status

Sessad Apf Voiron

Voiron, , France

Site Status

Countries

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France

Central Contacts

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Christelle PONS

Role: CONTACT

0630697431

Facility Contacts

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Marie HERNAULT

Role: primary

02.98.02.11.36

Adélie CHRISTIAENS

Role: primary

02 41 35 18 04

Isabelle ROCHAT

Role: primary

04 68 98 62 13

Gwenaela DUSSOLLE

Role: primary

01 48 68 45 90

Eloïse ROI

Role: primary

06 49 46 92 50

Marion PRIGENT

Role: primary

02 90 94 41 88

Angélique HAMAMIE

Role: primary

03 80 41 08 22

Katell BOURHIS

Role: primary

02 98 47 63 83

Anne Cécile DAMET

Role: primary

06 08 02 18 98

Elodie CREACH

Role: primary

Role: backup

07.68.33.81.29

Amélie ALIMOUSIN

Role: primary

01 41 53 09 09

Magali EGRETEAU

Role: primary

06.73.04.52.71

Rose Marie LE TEXIER-TONNERRE

Role: primary

02.97.84.18.90

Charlotte LERNOUT

Role: primary

04 78 43 21 58

Pauline CREPIN

Role: primary

06 64 00 58 95

Audrey COMBEY

Role: primary

04 72 38 46 20

Cécile MOLIA

Role: primary

04 37 85 56 56

Anne-Marie ARNOULT

Role: primary

04 76 55 30 27

Emeline LANOE

Role: primary

02 40 49 50 50

Melanie PORTE

Role: primary

04 66 68 34 59

Catarine DA LUZ BELO MARTINS

Role: primary

04 66 64 21 88

Sophie CHAPELLIER

Role: primary

04 66 26 31 45

Joanna ARTIGAS

Role: primary

04 66 28 82 60

Antoni LLORET LLINARES

Role: primary

04 66 28 82 60

Amélie HAMAIN

Role: primary

02.97.82.61.93

Cécile RUAUD

Role: primary

05 61 75 22 04

Bénédicte RIEFENSTAHL

Role: primary

07 63 41 10 94

Freddy Guerin

Role: primary

04 75 71 32 82

Sarah CLEACH

Role: primary

02 98 29 34 95

Fabienne ROUMENOFF

Role: primary

04 77 91 23 10

Elodie VRAY

Role: primary

04 77 12 06 29

Vincent MEDART

Role: primary

02 40 00 01 11

Mathilde TAFFOREAU

Role: primary

02 43 51 72 70

Anthéa LOOS

Role: primary

03 88 21 16 52

Florence GAILLARD

Role: primary

06 71 91 66 81

Anne-Marie ARNOULT

Role: primary

04 76 55 30 27

Other Identifiers

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29BRC22.0257

Identifier Type: -

Identifier Source: org_study_id

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