Initial Parenteral Nutrition Education of Parent Assessment Plan (DISEPEIN)

Validation of an Educational Evaluation Plan and Assessment of Its Usefulness in Therapeutic Patient Education: Case of Pediatric Home Parenteral Nutrition

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.

Study Overview

• Status: Completed
• Conditions: Parenteral Nutrition
• Intervention / Treatment: Other: Self-report questionnaires

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parents; Parents of children in need of home parenteral nutrition and participating in initial therapeutic education program of Necker-Enfants Malades hospital.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Cécile LAMBE, MD, Assistance Publique - Hopitaux de Paris; Study Director: Cécile GODOT, MD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): September 25, 2021
• Study Completion (Actual): September 25, 2021

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Parenteral nutrition; Pediatric home parenteral nutrition; Parental therapeutic education; Educational evaluation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperphagia
• Other Study ID Numbers: APHP200894; 2020-A01159-30 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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