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Initial Parenteral Nutrition Education of Parent Assessment Plan (DISEPEIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816734
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

The department of gastroenterology, hepatology and pediatric nutrition at the Necker-Enfants Malades hospital has created an evaluation system for the initial therapeutic education program followed by parents of children requiring parenteral nutrition at the Necker-Enfants Malades hospital.

The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.


Condition or disease Intervention/treatment Phase
Parenteral Nutrition Other: Self-report questionnaires Not Applicable

Detailed Description:

Due to the highly technical nature of the care to be provided at home by parents of children in need of parenteral nutrition, an assessment of the acquisition of both factual knowledge provided to parents in hospital, but also of the reasoning, decision-making, technical skills and parents attitudes seem necessary and essential before the child's return to his home in order to guarantee his safety.

The department of gastroenterology, hepatology and pediatric nutrition of Necker-Enfants Malades hospital has developed an educational assessment system based on previous studies in this field. Composed of 4 tools, this plan allows a complete assessment with relevant educational decision fields of the set of skills that parents must master to cope with their child's illness on a daily basis, following their participation in the initial program of therapeutic education offered by the Necker hospital team.

The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Validation of an Educational Evaluation Plan and Assessment of Its Usefulness in Therapeutic Patient Education: Case of Pediatric Home Parenteral Nutrition
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Parents
Parents of children in need of home parenteral nutrition and participating in initial therapeutic education program of Necker-Enfants Malades hospital.
 Other: Self-report questionnaires

Evaluation system of initial therapeutic education program about pediatric home parenteral nutrition.

The assessment takes place after the parents have participated in the therapeutic education program and before their child returns home.


Outcome Measures
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Primary Outcome Measures :
  1. Usefulness by parent [ Time Frame: Day 1 ]

    Perceived usefulness of the evaluation session by the learners -parents- collected via a self-report questionnaire.

    4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.



Secondary Outcome Measures :
  1. Usefulness by carer [ Time Frame: Day 1 ]

    Perceived usefulness of the evaluation session by users -carers- collected via a self-report questionnaire.

    4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.


  2. Educational quality by parent [ Time Frame: Day 1 ]

    Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for parents.

    4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.


  3. Educational quality by carer [ Time Frame: Day 1 ]

    Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for carers.

    4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Holders of parental authority for children with parenteral nutrition participating in the initial education program of pediatric home parenteral nutrition of Necker hospital.
  • informed consent signed by the patient and the investigator.
  • patient affiliated to a social security scheme (beneficiary or beneficiary).

Exclusion Criteria:

  • Subject having difficulty understanding the French language.
  • Illiterate subject.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816734


Contacts
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Contact: Cécile LAMBE, MD 1 44 49 48 51 ext +33 cecile.lambe@aphp.fr
Contact: Hélène Morel 1 71 19 63 46 ext +33 helene.morel@aphp.fr

Locations
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France
Hôpital Necker-Enfants Malades Recruiting
Paris, France, 75015
Contact: Cécile LAMBE, MD    1 44 49 48 51 ext +33    cecile.lambe@aphp.fr   
Principal Investigator: Beyzagul TOKBILGIN, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Cécile LAMBE, MD Assistance Publique - Hôpitaux de Paris
Study Director: Cécile GODOT, MD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04816734    
Other Study ID Numbers: APHP200894
2020-A01159-30 ( Other Identifier: ID-RCB Number )
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parenteral nutrition
Pediatric home parenteral nutrition
Parental therapeutic education
Educational evaluation