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NCT Number: 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)

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.

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Key information

Conditions

Children with Chronic Illnesses Affecting Physical Health Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ildys Ty Yann, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kid'EM app" experimental group

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)

Kid'EM app control group

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)

Primary outcomes

  1. 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".

  2. 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".

Secondary outcomes

  1. Evaluate the evolution of the child's satisfaction with rehabilitation care

    Time frame: Baseline

    • Evaluation of changes in satisfaction with the care offered to the child using an EVA scale completed by the children at V1.

  2. Evaluate the evolution of the child's satisfaction with rehabilitation care

    Time frame: Week 14

    • Evaluation of changes in satisfaction with the care offered to the child using an EVA scale completed by the children at V4

  3. Evaluation of the improvement in the child's family's satisfaction with rehabilitation care

    Time frame: Baseline

    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.

  4. Evaluation of the improvement in the child's family's satisfaction with rehabilitation care

    Time frame: Week 14

    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.

  5. Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health

    Time frame: Baseline

    • Evaluation of the evolution of the PEDI-CAT scale

  6. 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 evolution of the PEDI-CAT scale

  7. Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health

    Time frame: Baseline

    • Evaluation of Disability Inventory-Computer Adaptative Test) completed by parents at V1.

  8. Evaluation of the improvement in the effectiveness of care offered to children with chronic illnesses impacting physical health

    Time frame: Week 14

    • Evaluation of Disability Inventory-Computer Adaptative Test) completed by parents at V1.

  9. 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 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.

  10. 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 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.

  11. 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 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.

  12. Assessing how to improve the quality of care by promoting child- and family-centered care;

    Time frame: Baseline

    • Evaluation of the evolution of the MPOC (Measure of Processes Of Care) questionnaire completed by parents at V1.

  13. Assessing how to improve the quality of care by promoting child- and family-centered care;

    Time frame: Baseline

    • Evaluation of the evolution of the MPOC (Measure of Processes Of Care) questionnaire completed by parents at V4.

  14. Assessing how to improve the quality of care by promoting child- and family-centered care;

    Time frame: Baseline

    • Evaluation of the evolution of the MPOC SP (Measure of Processes Of Care Service Providers) questionnaire completed by rehabilitation professionals at V1

  15. Assessing how to improve the quality of care by promoting child- and family-centered care;

    Time frame: Week 14

    • Evaluation of the evolution of the MPOC SP (Measure of Processes Of Care Service Providers) questionnaire completed by rehabilitation professionals at V4

  16. Evaluation of parents' empowerment during child rehabilitation follow-up

    Time frame: Baseline

    • Assessment of changes in the Psychological Empowerment Scale (PES) completed by parents at V1

  17. Evaluation of parents' empowerment during child rehabilitation follow-up

    Time frame: Week 14

    • Assessment of changes in the Psychological Empowerment Scale (PES) completed by parents at V4

  18. Evaluation of the acceptability, usability and quality of the "Kid'EM app"

    Time frame: Week 14

    • Usability of the "Kid'EM app" application with the System Usability Scale (SUS) questionnaire by parents at V4 in the "Kid'EM app" group.

  19. Evaluation of the acceptability, usability and quality of the "Kid'EM app"

    Time frame: Week 14

    • Quality of the "Kid'EM app" with the Mobile Application Rating Scale (MARS) by parents at V4 in the "Kid'EM app" group.

  20. Evaluation of quality improvement in goal setting

    Time frame: From week 14 to week 16

    • 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle PONS

CONTACT

[email protected]

0630697431

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: READ'APP'T

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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