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) (READ'APP'T)

February 3, 2025 updated by: University Hospital, Brest

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49100
      • Angers, France, 49100
      • Argeles Sur Mer, France, 66700
        • IEM Galaxie
        • Contact:
      • Aulnay-sous-Bois, France, 93600
      • Basse-Goulaine, France, 44115
      • Concarneau, France, 29900
      • Dijon, France, 21000
        • Dispositif sensoriel et moteur Clos Chauveau - DIJON
        • Contact:
      • Gouesnou, France, 29850
      • Grenoble, France, 38000
      • Landerneau, France, 29800
        • Cabinet de Kinésithérapie - Elodie CREACH
        • Contact:
          • Elodie CREACH
        • Contact:
      • Le Raincy, France, 93340
      • Lesneven, France, 29260
        • Cabinet d'ergothérapie - Maison des Korrigans
        • Contact:
      • Lorient, France, 56100
        • SESSAD A Denn Askell - KERPAPE
        • Contact:
      • Lyon, France, 65009
      • Lyon, France, 69007
      • Lyon, France, 69322
      • Miribel, France, 01700
      • Miribel, France, 01700
      • Nantes, France, 44300
      • Nîmes, France, 30029
      • Nîmes, France, 30900
        • Cabinet Jaures Kiné
        • Contact:
      • Nîmes, France, 30900
        • Cabinet Sophie CHAPELLIER
        • Contact:
      • Nîmes, France, 30900
        • IEM La Cigale
        • Contact:
      • Nîmes, France, 30900
      • Ploemeur, France, 56270
      • Ramonville-Saint-Agne, France, 31520
      • Rennes, France, 35200
      • Romans-sur-Isère, France, 26100
      • Roscoff, France, 29680
      • Saint Etienne, France, 42100
      • Saint-Nazaire, France, 44616
      • Saint-Saturnin, France, 72650
      • Saint-Étienne, France, 42000
      • Strasbourg, France, 67000
      • Vannes, France, 56500
        • SMR Vannes - Centre hospitalier bretagne atlantique
        • Contact:
      • Voiron, France, 38500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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):

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)
Sham Comparator: 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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
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
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".
From week 14 to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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
Week 14
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.
Baseline
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.
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 evolution of the PEDI-CAT scale
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 evolution of the PEDI-CAT scale
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 Disability Inventory-Computer Adaptative Test) completed by parents at V1.
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 Disability Inventory-Computer Adaptative Test) completed by parents at V1.
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 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.
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 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.
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
- 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.
Week 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 (Measure of Processes Of Care) questionnaire completed by parents at V1.
Baseline
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.
Baseline
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
Baseline
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
Week 14
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
Baseline
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
Week 14
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.
Week 14
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.
Week 14
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".
From week 14 to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC22.0257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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