Parenteral NutritionDISEPEINNCT04816734
Initial Parenteral Nutrition Education of Parent Assessment Plan
A study testing Self-report questionnaires in people with Parenteral Nutrition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- Self-report questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2021to 25 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Subject having difficulty understanding the French language.
- Illiterate subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of an Educational Evaluation Plan and Assessment of Its Usefulness in Therapeutic Patient Education: Case of Pediatric Home Parenteral Nutrition
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.
Read the 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.
- Conditions
- Parenteral Nutrition
- Being tested
- Self-report questionnaires
- Keywords
- Parenteral nutrition, Pediatric home parenteral nutrition, Parental therapeutic education, Educational evaluation
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-report questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents | Experimental | Parents of children in need of home parenteral nutrition and participating in initial therapeutic education program of Necker-Enfants Malades hospital. Receives: Other: Self-report questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usefulness by parent
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.
Measured: Day 1
Secondary outcomes (3)
Usefulness by carer
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.
Measured: Day 1
Educational quality by parent
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.
Measured: Day 1
Educational quality by carer
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start25 Mar 2021
- Primary completion25 Sep 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Cécile LAMBE, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisCécile GODOT, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816734
- Sponsor's protocol ID
- APHP200894
- Other IDs
- 2020-A01159-30
- Acronym
- DISEPEIN
- Status last verified
- Sep 2025
- First submitted
- 23 Mar 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Educational Evaluation Plan and Assessment of Its Usefulness in Therapeutic Patient Education: Case of Pediatric Home Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT04816734
- Acronym / sponsor ID
- DISEPEIN / APHP200894
- Conditions
- Parenteral Nutrition
- Keywords
- Parenteral nutrition, Pediatric home parenteral nutrition, Parental therapeutic education, Educational evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents | Experimental | Other: Self-report questionnairesParents of children in need of home parenteral nutrition and participating in initial therapeutic education program of Necker-Enfants Malades hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Subject having difficulty understanding the French language.
- Illiterate subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-report questionnairesEvaluation 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. | Other | Parents |
Primary outcome
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.
3 secondary outcomes
Usefulness by carer
Time frame: Day 1
Educational quality by parent
Time frame: Day 1
Educational quality by carer
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile LAMBE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Cécile GODOT, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-report questionnaires in people with Parenteral Nutrition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usefulness by parent (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.