Clinical trial NCT05048030: Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition
Official title: Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Home Parenteral Nutrition
Lead sponsor: Imagine Institute
Sponsor class: OTHER
Collaborators: name: Hôpital Necker-Enfants Malades
First posted: 2021-09-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic data and socio-familial life style with a child on long-term
timeFrame: Base line
measure: Data involving the management of HPN
timeFrame: Base line
Secondary outcomes:
measure: Perception of the familial impact of HPN on life style in case of protracted HPN dependency
timeFrame: Base line
measure: Satisfaction level of the management by the HPN expert center
timeFrame: Base Line
measure: Factors influencing the familial burden
timeFrame: Base Line
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker - Enfants malades
Study officials:
affiliation: Department of Pediatric Gastroenterology-Hepatology-Nutrition, National Reference Center for Rare Digestive Diseases, Pediatric Intestinal Failure Rehabilitation Center
name: Olivier Goulet, MD, PHD
role: STUDY_DIRECTOR
References: