a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

NCT ID: NCT02909205

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrostomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control

First phase : before training / sensitization / booklet delivery

Group Type OTHER

sensitization / educational program

Intervention Type 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

post intervention

Second phase : after training / sensitization / booklet delivery

Group Type OTHER

training / sensitization program

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric VALLA

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frédéric VALLA

Role: CONTACT

4 72 12 97 37 ext. +33

Behrouz Kassaï

Role: CONTACT

472 357 231 ext. +33

Facility Contacts

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Frédéric VALLA

Role: primary

Other Identifiers

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D21537

Identifier Type: -

Identifier Source: org_study_id

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