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)

Обзор

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.

Вмешательства

• Другое 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)
• Другое 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

Первичные конечные точки

• Quality of the first two objectives set for each child during the 12-week 'Kid'EM app' or 'app control' period [Срок оценки: 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 [Срок оценки: From week 14 to week 16]

Вторичные конечные точки (12)

• Evaluate the evolution of the child's satisfaction with rehabilitation care [Срок оценки: Baseline]
• Evaluate the evolution of the child's satisfaction with rehabilitation care [Срок оценки: Week 14]
• Evaluation of the improvement in the child's family's satisfaction with rehabilitation care [Срок оценки: Baseline]
• Evaluation of the improvement in the child's family's satisfaction with rehabilitation care [Срок оценки: Week 14]
• Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health [Срок оценки: Baseline]
• Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health [Срок оценки: Week 14]
• Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health [Срок оценки: Baseline]
• Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health [Срок оценки: Week 14]
• Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health [Срок оценки: Up to 3 weeks]
• Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health [Срок оценки: Up to 3 weeks]
• Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health [Срок оценки: Week 14]
• Assessing how to improve the quality of care by promoting child- and family-centered care; [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 36 центров

• 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
• … и ещё 28 центров

Идентификаторы

NCT: NCT06475950 · 29BRC22.0257

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗