a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised (Gastrostomy)

September 16, 2016 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Recruiting
        • Hopital Femme Mere Enfant
        • Contact:
          • Frédéric VALLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control
First phase : before training / sensitization / booklet delivery
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
Other: post intervention
Second phase : after training / sensitization / booklet delivery
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from knowledge score
Time Frame: Between day 0 and day 5
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Frédéric VALLA, Hospices civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D21537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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