a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

Gastrostomy Clinical Trial

— Gastrostomy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02909205
• Other study ID #: D21537
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2016
• Last updated: September 16, 2016
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: Frédéric VALLA
• Phone: 4 72 12 97 37
• Email: Frederic.valla[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrostomy

Intervention

Other:
• sensitization / educational program
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
• training / sensitization program
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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No