NCT04816734

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

March 23, 2021

Last Update Submit

September 8, 2025

Conditions

Parenteral Nutrition

Keywords

Parenteral nutritionPediatric home parenteral nutritionParental therapeutic educationEducational evaluation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Usefulness by carer

    Day 1

  • Educational quality by parent

    Day 1

  • Educational quality by carer

    Day 1

Study Arms (1)

Parents

EXPERIMENTAL

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

Interventions

Self-report questionnairesOTHER

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.

Parents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Subject having difficulty understanding the French language.
  • Illiterate subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cécile LAMBE, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Cécile GODOT, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

March 25, 2021

Primary Completion

September 25, 2021

Study Completion

September 25, 2021

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)