a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to improve care practice related to gastrostomy management. This a before-after study, aimed at evaluating knowledge of care givers, families and patients about gastrostomy management. The intervention includes 1) A training in a care protocol for hospital care givers, and 2) A booklet for patients, families, and outpatient care givers. The evaluation criterion is a questionnaire to assess knowledge of hospital care givers, patients, families, and outpatient care givers.

Official Title
-----------------
Development and Evaluation of a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

Conditions
-----------------
Gastrostomy

Intervention / Treatment
-----------------
* Other: sensitization / educational program
* Other: training / sensitization program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parents and hospital care givers of children undergoing gastrostomy who accept to participate. Exclusion Criteria: family unable to understand French language, caregiver who has previously answered to the study questionnaire

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>First phase : before training / sensitization / booklet delivery | Other: sensitization / educational program<br>* the intervention program was built based on the results of the pre-intervention phase survey, about the knowledge of caregivers and parents of children with gastrostomy about gastrostomy management. It consists in booklets for caregivers and parents of children. This booklet is the support of a specific training of carers and parents of children who have recently benefitted from a gastrostomy<br>|
| Other: post intervention<br>Second phase : after training / sensitization / booklet delivery | Other: training / sensitization program<br>* diffusion of gastrostomy in-hospital care protocols, and booklets for families. These tools have been prepared by a pilot group of professional of the investigating centers.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from knowledge score | The anonymised questionnaires are identified by a number assigned to the selected case; they include items about global knowledge about gastrostomy, its day to day use, possible complications, and surveillance. | Between day 0 and day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child, gastrostomy, supportive care, educational program