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

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

1. Evaluation of the familial impact of HPN, and the way it is perceived
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. Analysis of the factors related to specific distress and the protective factors

Study Overview

• Status: Recruiting
• Conditions: Home Parenteral Nutrition

Detailed Description

Gastrointestinal diseases may cause intestinal failure (IF) requiring long term parenteral nutrition (PN) which is, most of the time, performed at home (HPN).

However such conditions represent a great burden for the parents and the family.

The birth of a child with such disease changes the life of the entire family including life style, leisures, social relationships and professional activities.

These condition obligate to change the personal and familial organization according to the course of the disease. The PN treatment which was seen as life saving when first started might become a burden altogether physically and psychologically for the child and his/her family.

The Necker-Enfants Malades hospital developed home PN in the early eighties as an alternative to very long hospitalizations.

Nowadays, there are 7 expert centers for HPN in France. The Necker HPN program is the oldest and the largest looking after i a third of the 400 children on HPN in France.

Our organization is based on a specializednursing team together with medical doctors specialized in pediatric clinical nutrition.

The nursing team is also a teaching team for training the parents for daily PN care. The HPN team works in collaboration with professional partners: pharmacists, dieticians, psychologists, occupational therapistsand speech specialists as well as with social workers.

Results of our clinical activities have been published in international peer review journals. However those publications reported only clinical data in terms of diagnosis, prognosis, mortality, morbidity and growth.There was any data on family quality of life (QOL) and on life style changes (LSC). In other words, by reporting only on medical aspects, there was any analyze on familial, psychosocial and professional impact of long term HPN.

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Isabelle Eicher, MSC; Phone Number: 0033 1 44 49 44 17; Email: isabelle.eicher@aphp.fr
• Study Contact Backup: Name: Yasmine Ainouz; Email: yasmine.ainouz@institutimagine.org

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hopital Necker - Enfants Malades
    • Contact: Olivier Goulet; Email: oliver.goulet@aphp.fr
    • Contact: Isabelle Eicher; Email: isabelle.eicher@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal of the parents to participate to the survey

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of the familial impact of HPN on life style in case of protracted HPN dependency	Child development	Base line
Satisfaction level of the management by the HPN expert center	Medical and nursing logistics	Base Line
Factors influencing the familial burden	Type of disease	Base Line

Collaborators and Investigators

• Sponsor: Imagine Institute
• Collaborators: Hôpital Necker-Enfants Malades
• Investigators: Study Director: Olivier Goulet, MD, PHD, Department of Pediatric Gastroenterology-Hepatology-Nutrition, National Reference Center for Rare Digestive Diseases, Pediatric Intestinal Failure Rehabilitation Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HJ-21-NPAD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No