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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04816734
Other study ID # APHP200894
Secondary ID 2020-A01159-30
Status Completed
Phase N/A
First received
Last updated
Start date March 25, 2021
Est. completion date September 25, 2021

Study information

Verified date May 2022
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The department of gastroenterology, hepatology and pediatric nutrition at the Necker-Enfants Malades hospital has created an evaluation system for the initial therapeutic education program followed by parents of children requiring parenteral nutrition at the Necker-Enfants Malades hospital. The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.


Description:

Due to the highly technical nature of the care to be provided at home by parents of children in need of parenteral nutrition, an assessment of the acquisition of both factual knowledge provided to parents in hospital, but also of the reasoning, decision-making, technical skills and parents attitudes seem necessary and essential before the child's return to his home in order to guarantee his safety. The department of gastroenterology, hepatology and pediatric nutrition of Necker-Enfants Malades hospital has developed an educational assessment system based on previous studies in this field. Composed of 4 tools, this plan allows a complete assessment with relevant educational decision fields of the set of skills that parents must master to cope with their child's illness on a daily basis, following their participation in the initial program of therapeutic education offered by the Necker hospital team. The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date September 25, 2021
Est. primary completion date September 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Holders of parental authority for children with parenteral nutrition participating in the initial education program of pediatric home parenteral nutrition of Necker hospital. - informed consent signed by the patient and the investigator. - patient affiliated to a social security scheme (beneficiary or beneficiary). Exclusion Criteria: - Subject having difficulty understanding the French language. - Illiterate subject.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self-report questionnaires
Evaluation system of initial therapeutic education program about pediatric home parenteral nutrition. The assessment takes place after the parents have participated in the therapeutic education program and before their child returns home.

Locations

Country Name City State
France Hôpital Necker-Enfants Malades Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Usefulness by parent Perceived usefulness of the evaluation session by the learners -parents- collected via a self-report questionnaire.
4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.
Day 1
Secondary Usefulness by carer Perceived usefulness of the evaluation session by users -carers- collected via a self-report questionnaire.
4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.
Day 1
Secondary Educational quality by parent Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for parents.
4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.
Day 1
Secondary Educational quality by carer Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for carers.
4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.
Day 1
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