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Not yet recruiting NCT06475950

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)

No phase Interventional Children with Chronic Illnesses Affecting Physical Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kid'EM app" experimental group, Kid'EM app control group.
Who it may be relevant to
Registry conditions: Children with Chronic Illnesses Affecting Physical Health. Basic parameters: 1 year — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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)
  • 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 seco

Primary outcome measures

  • 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 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 36 centers
  • Ildys Ty Yann — Angers
  • Les Capucins Angers — Angers
  • IEM Galaxie — Argeles
  • SESSAD 93 - Aulnay — Aulnay-sous-Bois
  • SESSAD APF Basse Goulaine — Basse-Goulaine
  • SMR Concarneau — Concarneau
  • Dispositif sensoriel et moteur Clos Chauveau - DIJON — Dijon
  • Sessad APF France Handicap du Finistère — Gouesnou
  • … and 28 more centers

Identifiers

NCT: NCT06475950 · 29BRC22.0257

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗