Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition

NCT05048030 | Completed

• 1 other identifier: HJ-21-NPAD
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Description of the life style of patients and families during the course of long term HPN.

1. 1.Evaluation of the familial impact of HPN, and the way it is perceived
2. 2.Evaluation of the satisfaction regarding the management by the multi-professional team (Medical, nursing, home care company and logistic, social, psychologist etc..) for improving the global management of these challenging patients
3. 3.Analysis of the factors related to specific distress and the protective factors

Conditions

Home Parenteral Nutrition

Outcome Measures

Primary Outcomes (2)

• Demographic data and socio-familial life style with a child on long-term

  socio-familial life style

  Base line

• Data involving the management of HPN

  Logistics organization

  Base line

Secondary Outcomes (3)

• Perception of the familial impact of HPN on life style in case of protracted HPN dependency

  Base line

• Satisfaction level of the management by the HPN expert center

  Base Line

• Factors influencing the familial burden

  Base Line

Eligibility Criteria

• Age: 18 Months - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, and their entire family, with gastrointestinal diseases and intestinal failure (IF) requiring long term parenteral nutrition, performed at home (HPN).

You may qualify if:

• Patients followed up by the Necker HPN expert center
• HPN ≥ 12 months
• HPN between 2004 and 2020
• Parents reading and writing French language

You may not qualify if:

• Refusal of the parents to participate to the survey

Sponsors & Collaborators

• Imagine Institute: lead
• Hôpital Necker-Enfants Malades: collaborator

Study Sites (1)

Hopital Necker - Enfants malades

Paris, France

Location

Study Officials

• Olivier Goulet, MD, PHD

  Department of Pediatric Gastroenterology-Hepatology-Nutrition, National Reference Center for Rare Digestive Diseases, Pediatric Intestinal Failure Rehabilitation Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 17, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

FR (1)