Development of Basic Technology for Communication Support AI to Visualize the Intentions of Home-Based Children with Profound Intellectual Multiple Disabilities with High Medical Needs

JRCT ID: jRCT1030220535

Registered date:25/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Children with Profound Multiple and Intellectual Disabilities
• Date of first enrollment: 16/12/2022
• Target sample size: 10
• Study type: Observational

Outcome(s)

Primary Outcome

Medical record information
1. Background information: age, disease name, complications
2. Critically ill child score
3. Vital signs: body temperature, pulse, respiration, oxygen saturation monitors values
4. Details of medical care 5. types of home visit nursing and outpatient facilities
Patient group
1. Images of communication scenes: intentions, Feature value
2. Vital signs
3. Interview content regarding signatures: intentions, Feature value

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 20age old

Include criteria

Subjects
Must meet all the following criteria.1. Age at enrollment is less than 20 years old. Children with Profound multiple and Intellectual Disabilities belong to 1 to 4 of the Ohshima classification. 2. Able to communicate their intentions to family members and facility staff using signs. 3. Medical needs [ tracheostomy, gastric bandage, tube feeding, suctioning]. 4. Uses home nursing or daycare facilities. 5. The family understands the child's signs and intentions and can explain the basis for their decisions.
Nurses and family members
1. Family members and nurses who have given their consent to have their conversations with the patient during communication situations recorded and documented.

Exclude criteria

Subjects
Patients with any of the following conditions will not be included in this study
1. Patients with the intractable neurological disease who have established communication using a letter board.
2. Children with Profound Multiple and Intellectual Disabilities who can communicate using words
3. Children with Profound Multiple and Intellectual Disabilities who are staying in an institution for an extended period of time[except for respite use]
4. When it is determined that the child's condition is unstable or the family cannot afford the living situation.

Related Information

• Primary Sponsor: Tomomi Sato
• Secondary Sponsor: Japan Society for The Promotion of Science