Children with Chronic Illnesses Affecting Physical HealthREAD'APP'TNCT06475950
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)
A study testing Kid'EM app" experimental group in people with Children with Chronic Illnesses Affecting Physical Health, run by University Hospital, Brest at 36 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Children with Chronic Illnesses Affecting Physical Health
- What is being tested?
- Kid'EM app" experimental group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 36 sitesFrance
- Study dates
- 1 Mar 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
France36 sites
Ildys Ty Yann
Angers, 49100
Marie HERNAULT, 02.98.02.11.36, kines.ssrpedia-tyyann@ildys.org
Les Capucins Angers
Angers, 49100
Adélie CHRISTIAENS, 02 41 35 18 04, achristiaens@les-capucins-angers.fr
IEM Galaxie
Argeles, 66700
Isabelle ROCHAT, 04 68 98 62 13, irochat@ussap.fr
SESSAD 93 - Aulnay
Aulnay-sous-Bois, 93600
Gwenaela DUSSOLLE, 01 48 68 45 90, gdussolle@envoludia.org
SESSAD APF Basse Goulaine
Basse-Goulaine, 44115
Eloïse ROI, 06 49 46 92 50, eloise.roi@apf.asso.fr
SMR Concarneau
Concarneau, 29900
Marion PRIGENT, 02 90 94 41 88, m.prigent@ch-cornouaille.fr
Dispositif sensoriel et moteur Clos Chauveau - DIJON
Dijon, 21000
Angélique HAMAMIE, 03 80 41 08 22, angelique.hamamie@pepcbfc.org
Sessad APF France Handicap du Finistère
Gouesnou, 29850
Katell BOURHIS, 02 98 47 63 83, katell.bourhis@apf.asso.fr
CAMSP APF Grenoble
Grenoble, 38000
Anne Cécile DAMET, 06 08 02 18 98, anne-cecile.famet@apf.asso.fr
Cabinet de Kinésithérapie - Elodie CREACH
Landerneau, 29800
Elodie CREACH
07.68.33.81.29, ecreach.mk@gmail.com
SESSAD 93-Raincy
Le Raincy, 93340
Amélie ALIMOUSIN, 01 41 53 09 09, alimousin@envoludia.org
Cabinet d'Ergothérapie - Maison des Korrigans
Lesneven, 29260
Magali EGRETEAU, 06.73.04.52.71, egreteaumagali@yahoo.fr
SESSAD A Denn Askell - KERPAPE
Lorient, 56100
Rose Marie LE TEXIER-TONNERRE, 02.97.84.18.90, sessad.qualite@vyv3.fr
CAMSP Nelson Mandela
Lyon, 65009
Charlotte LERNOUT, 04 78 43 21 58, charlotte.lernout@odyneo.fr
CAPEDIA
Lyon, 69007
Pauline CREPIN, 06 64 00 58 95, cabinet.capedia@gmail.com
CMCR Les Massues
Lyon, 69322
Audrey COMBEY, 04 72 38 46 20, audrey.combey@croix-rouge.fr
CMRP Romans Ferrari - Service Brulologie
Miribel, 01700
Cécile MOLIA, 04 37 85 56 56, cecile.molia@romansferrari.fr
CMRP Romans Ferrari - Service Neurologie
Miribel, 01700
Anne-Marie ARNOULT, 04 76 55 30 27, anne-marie.arnould@apf.asso.fr
IEM La Marrière
Nantes, 44300
Emeline LANOE, 02 40 49 50 50, emeline.lanoe@apf.asso.fr
CHU Carémeau
Nîmes, 30029
Melanie PORTE, 04 66 68 34 59, melanie.porte@chu-nimes.fr
Cabinet Jaures Kiné
Nîmes, 30900
Catarine DA LUZ BELO MARTINS, 04 66 64 21 88, jaureskine@laposte.net
Cabinet Sophie CHAPELLIER
Nîmes, 30900
Sophie CHAPELLIER, 04 66 26 31 45, scntkc30@yahoo.com
IEM La Cigale
Nîmes, 30900
Joanna ARTIGAS, 04 66 28 82 60, kine@la-cigale.fr
SESSAD La Cigale
Nîmes, 30900
Antoni LLORET LLINARES, 04 66 28 82 60, kinesessad@la-cigale.fr
IEM Ar Menn
Ploemeur, 56270
Amélie HAMAIN, 02.97.82.61.93, amelie.hamain@vyv3.fr
Centre Paul DOTTIN
Ramonville-Saint-Agne, 31520
Cécile RUAUD, 05 61 75 22 04, Cecile.ruaud@asei.asso.fr
SESSAD Henri Matisse
Rennes, 35200
Bénédicte RIEFENSTAHL, 07 63 41 10 94, b.riefenstahl@rey-leroux.com
SESSAD Romans
Romans-sur-Isère, 26100
Freddy Guerin, 04 75 71 32 82, fguerin@apajh-drome.org
SMR pédiatrique ILDYS
Roscoff, 29680
Sarah CLEACH, 02 98 29 34 95, ergo.enfant@ildys.org
SESSAD Saint Etienne
Saint-Etienne, 42000
Fabienne ROUMENOFF, 04 77 91 23 10, fab.roumenoff-sessd-afb42@orange.fr
CHU Saint Etienne - MPR Pédiatrique
Saint-Etienne, 42100
Elodie VRAY, 04 77 12 06 29, ergo.mprped-hc@chu-st-etienne.fr
CMPR Côte d'Amour
Saint-Nazaire, 44616
Vincent MEDART, 02 40 00 01 11, vincent.medart@association-penbron.fr
Centre de l'Arche
Saint-Saturnin, 72650
Mathilde TAFFOREAU, 02 43 51 72 70, mathilde.tafforeau@asso-prh.fr
UGECAM Strasbourg
Strasbourg, 67000
Anthéa LOOS, 03 88 21 16 52, anthea.loos@ugecam.assurance-maladie.fr
SMR Vannes - Centre hospitalier bretagne atlantique
Vannes, 56500
Florence GAILLARD, 06 71 91 66 81, florence.gaillard@hotmail.fr
Sessad Apf Voiron
Voiron, 38500
Anne-Marie ARNOULT, 04 76 55 30 27, anne-marie.arnould@apf.asso.fr
About this study
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.
- Being tested
- Kid'EM app" experimental group, Kid'EM app control group
- Keywords
- Chronic disease, Children
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kid'EM app" experimental groupOther
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)
Kid'EM app control groupOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Kid'EM app" experimental group | Active comparator | 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. Receives: Other: Kid'EM app" experimental group |
| Kidem app control group | Sham comparator | 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. Receives: Other: Kid'EM app control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the first two objectives set for each child during the 12-week 'Kid'EM app' or 'app control' period
Quality, adequate or not (binary criterion, measured with the SMART goal evaluation method: SMART GEM), of the first two goals set for each child during the 12-week period of use of the "Kid'EM app" or "control app".
Measured: Up to 3 weeks
Quality of the first two objectives set for each child during the 12-week 'Kid'EM app' or 'app control' period
Quality, adequate or not (binary criterion, measured with the SMART goal evaluation method: SMART GEM), of the first two goals set for each child during the 12-week period of use of the "Kid'EM app" or "control app".
Measured: From week 14 to week 16
Secondary outcomes (20)
Evaluate the evolution of the child's satisfaction with rehabilitation care
- Evaluation of changes in satisfaction with the care offered to the child using an EVA scale completed by the children at V1.
Measured: Baseline
Evaluate the evolution of the child's satisfaction with rehabilitation care
- Evaluation of changes in satisfaction with the care offered to the child using an EVA scale completed by the children at V4
Measured: Week 14
Evaluation of the improvement in the child's family's satisfaction with rehabilitation care
Assessment of changes in satisfaction with the care offered to the child and his/her family using the CSQ8 scale completed by parents at V1.
Measured: Baseline
Evaluation of the improvement in the child's family's satisfaction with rehabilitation care
Assessment of changes in satisfaction with the care offered to the child and his/her family using the CSQ8 scale completed by parents at V1.
Measured: Week 14
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
- Evaluation of the evolution of the PEDI-CAT scale
Measured: Baseline
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
- Evaluation of the evolution of the PEDI-CAT scale
Measured: Week 14
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
- Evaluation of Disability Inventory-Computer Adaptative Test) completed by parents at V1.
Measured: Baseline
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
- Evaluation of Disability Inventory-Computer Adaptative Test) completed by parents at V1.
Measured: Week 14
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
- Evaluation of the evolution of performance and satisfaction levels in achieving the first two rehabilitation goals determined by the rehabilitation professional, by parents at V2 (1st goal), using the CORM (Canadian Measure of Occupational Performance) evaluation methodology.
Measured: Up to 3 weeks
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
- Evaluation of the evolution of performance and satisfaction levels in achieving the first two rehabilitation goals determined by the rehabilitation professional, by parents at V3 (2d goal), using the CORM (Canadian Measure of Occupational Performance) evaluation methodology.
Measured: Up to 3 weeks
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
- Evaluation of the evolution of performance and satisfaction levels in achieving the first two rehabilitation goals determined by the rehabilitation professional, by parents at V4 (both 1st goals), using the CORM (Canadian Measure of Occupational Performance) evaluation methodology.
Measured: Week 14
Assessing how to improve the quality of care by promoting child- and family-centered care;
- Evaluation of the evolution of the MPOC (Measure of Processes Of Care) questionnaire completed by parents at V1.
Measured: Baseline
Assessing how to improve the quality of care by promoting child- and family-centered care;
- Evaluation of the evolution of the MPOC (Measure of Processes Of Care) questionnaire completed by parents at V4.
Measured: Baseline
Assessing how to improve the quality of care by promoting child- and family-centered care;
- Evaluation of the evolution of the MPOC SP (Measure of Processes Of Care Service Providers) questionnaire completed by rehabilitation professionals at V1
Measured: Baseline
Assessing how to improve the quality of care by promoting child- and family-centered care;
- Evaluation of the evolution of the MPOC SP (Measure of Processes Of Care Service Providers) questionnaire completed by rehabilitation professionals at V4
Measured: Week 14
Evaluation of parents' empowerment during child rehabilitation follow-up
- Assessment of changes in the Psychological Empowerment Scale (PES) completed by parents at V1
Measured: Baseline
Evaluation of parents' empowerment during child rehabilitation follow-up
- Assessment of changes in the Psychological Empowerment Scale (PES) completed by parents at V4
Measured: Week 14
Evaluation of the acceptability, usability and quality of the "Kid'EM app"
- Usability of the "Kid'EM app" application with the System Usability Scale (SUS) questionnaire by parents at V4 in the "Kid'EM app" group.
Measured: Week 14
Evaluation of the acceptability, usability and quality of the "Kid'EM app"
- Quality of the "Kid'EM app" with the Mobile Application Rating Scale (MARS) by parents at V4 in the "Kid'EM app" group.
Measured: Week 14
Evaluation of quality improvement in goal setting
- Evaluation of the average SMART GEM score for the first two objectives established for each child during the 12-week period of use of the "Kid'EM app" or "control app".
Measured: From week 14 to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children with Chronic Illnesses Affecting Physical HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "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."
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475950
- Sponsor's protocol ID
- 29BRC22.0257
- Acronym
- READ'APP'T
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06475950
- Acronym / sponsor ID
- READ'APP'T / 29BRC22.0257
- Keywords
- Chronic disease, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "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."
| Arm | Type | Receives |
|---|---|---|
| Kid'EM app" experimental group | Active comparator | Other: Kid'EM app" experimental groupThis 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. |
| Kidem app control group | Sham comparator | Other: Kid'EM app control groupThis 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kid'EM app" experimental groupIn 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) | Other | Kid'EM app" experimental group |
| Kid'EM app control groupUse 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) | Other | Kidem app control group |
Primary outcome
Quality of the first two objectives set for each child during the 12-week 'Kid'EM app' or 'app control' period
Time frame: Up to 3 weeks
Quality, adequate or not (binary criterion, measured with the SMART goal evaluation method: SMART GEM), of the first two goals set for each child during the 12-week period of use of the "Kid'EM app" or "control app".
Quality of the first two objectives set for each child during the 12-week 'Kid'EM app' or 'app control' period
Time frame: From week 14 to week 16
Quality, adequate or not (binary criterion, measured with the SMART goal evaluation method: SMART GEM), of the first two goals set for each child during the 12-week period of use of the "Kid'EM app" or "control app".
20 secondary outcomes
Evaluate the evolution of the child's satisfaction with rehabilitation care
Time frame: Baseline
Evaluate the evolution of the child's satisfaction with rehabilitation care
Time frame: Week 14
Evaluation of the improvement in the child's family's satisfaction with rehabilitation care
Time frame: Baseline
Evaluation of the improvement in the child's family's satisfaction with rehabilitation care
Time frame: Week 14
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
Time frame: Baseline
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
Time frame: Week 14
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
Time frame: Baseline
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
Time frame: Week 14
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
Time frame: Up to 3 weeks
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
Time frame: Up to 3 weeks
Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health
Time frame: Week 14
Assessing how to improve the quality of care by promoting child- and family-centered care;
Time frame: Baseline
Assessing how to improve the quality of care by promoting child- and family-centered care;
Time frame: Baseline
Assessing how to improve the quality of care by promoting child- and family-centered care;
Time frame: Baseline
Assessing how to improve the quality of care by promoting child- and family-centered care;
Time frame: Week 14
Evaluation of parents' empowerment during child rehabilitation follow-up
Time frame: Baseline
Evaluation of parents' empowerment during child rehabilitation follow-up
Time frame: Week 14
Evaluation of the acceptability, usability and quality of the "Kid'EM app"
Time frame: Week 14
Evaluation of the acceptability, usability and quality of the "Kid'EM app"
Time frame: Week 14
Evaluation of quality improvement in goal setting
Time frame: From week 14 to week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kid'EM app" experimental group in people with Children with Chronic Illnesses Affecting Physical Health, run by University Hospital, Brest at 36 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle PONS (0630697431, christelle.pons@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of the first two objectives set for each child during the 12-week 'Kid'EM app' or 'app control' period (time frame: Up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.