a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

NCT02909205 | Unknown

• 1 other identifier: D21537
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy

Keywords

child; gastrostomy; supportive care; educational program

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control

OTHER

First phase : before training / sensitization / booklet delivery

Other: sensitization / educational program

post intervention

OTHER

Second phase : after training / sensitization / booklet delivery

Other: training / sensitization program

Interventions

sensitization / educational program OTHER

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

control

training / sensitization program OTHER

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.

post intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• parents and hospital care givers of children undergoing gastrostomy who accept to participate.

You may not qualify if:

• family unable to understand French language, caregiver who has previously answered to the study questionnaire

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, France

RECRUITING

Study Officials

• Frédéric VALLA

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric VALLA

CONTACT

4 72 12 97 37; Frederic.valla@chu-lyon.fr

Behrouz Kassaï

CONTACT

472 357 231; behrouz.kassai-koupai@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 21, 2016
• Study Start: November 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)