Hospitalization in Cardiology, Orthopaedic Surgery or Endocrinology DepartmentsALIMSNCT03520296
Descriptive Study on the Evaluation of Well-being in Relation to Diet and Nutrition and Comparison Between Three Care Units in the Dijon University Hospital Centre
An observational study of Hospitalization in Cardiology, Orthopaedic Surgery or Endocrinology Departments, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to qualify patient well-being in relation to diet. The notion of dietary well-being is believed to be subjective and we wish to base it on tangible parameters (presentation of meals, variety of menus, social interaction, environment, convenience, pleasure...) in order to establish a score of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization in Cardiology, Orthopaedic Surgery or Endocrinology Departments
- What is being tested?
- Questionnaire
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2018to 24 Jul 2018
- Phase
- Observational
- 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
Study population: patients hospitalized in cardiology, orthopaedic surgery or endocrinology departments
Who may be able to join
- person who has given oral consent
- adult
- persons admitted to cardiology, orthopaedic surgery and endocrinology units
- absence of cognitive problems
- oral food intake
Who cannot join
- no affiliation to a national health insurance scheme
- current pregnancy
- blended diet
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to qualify patient well-being in relation to diet. The notion of dietary well-being is believed to be subjective and we wish to base it on tangible parameters (presentation of meals, variety of menus, social interaction, environment, convenience, pleasure...) in order to establish a score of dietary well-being that we will then correlate to the patient's nutritional status. This tool can then be used more widely as an assessment tool within health institutions.
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire evaluating well-being in relation to diet and nutrition
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized in the cardiology unit | Not described Receives: Other: Questionnaire | |
| Patients hospitalized in the orthopedic surgery unit | Not described Receives: Other: Questionnaire | |
| Patients hospitalized in the endocrinology unit | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire evaluating well-being in relation to diet and nutrition
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start12 Jan 2018
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalization in Cardiology, Orthopaedic Surgery or Endocrinology DepartmentsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520296
- Sponsor's protocol ID
- BRINDISI UB 2016
- Acronym
- ALIMS
- Status last verified
- Apr 2018
- First submitted
- 27 Apr 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study on the Evaluation of Well-being in Relation to Diet and Nutrition and Comparison Between Three Care Units in the Dijon University Hospital Centre
- ClinicalTrials.gov ID
- NCT03520296
- Acronym / sponsor ID
- ALIMS / BRINDISI UB 2016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 9 May 2018 (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 aim of this study is to qualify patient well-being in relation to diet. The notion of dietary well-being is believed to be subjective and we wish to base it on tangible parameters (presentation of meals, variety of menus, social interaction, environment, convenience, pleasure...) in order to establish a score of dietary well-being that we will then correlate to the patient's nutritional status. This tool can then be used more widely as an assessment tool within health institutions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized in the cardiology unit | – | Other: Questionnaire |
| Patients hospitalized in the orthopedic surgery unit | – | Other: Questionnaire |
| Patients hospitalized in the endocrinology unit | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in cardiology, orthopaedic surgery or endocrinology departments
Key inclusion criteria (5 listed)
- person who has given oral consent
- adult
- persons admitted to cardiology, orthopaedic surgery and endocrinology units
- absence of cognitive problems
- oral food intake
Key exclusion criteria (3 listed)
- no affiliation to a national health insurance scheme
- current pregnancy
- blended diet
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 |
|---|---|---|
| QuestionnaireQuestionnaire evaluating well-being in relation to diet and nutrition | Other | Patients hospitalized in the cardiology unit, Patients hospitalized in the endocrinology unit, Patients hospitalized in the orthopedic surgery unit |
Primary outcome
Questionnaire evaluating well-being in relation to diet and nutrition
Time frame: Baseline
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 26 Nov 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization in Cardiology, Orthopaedic Surgery or Endocrinology Departments, run by Centre Hospitalier Universitaire Dijon 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 5 inclusion and 3 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 26 Nov 2018. 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?
Questionnaire evaluating well-being in relation to diet and nutrition (time frame: Baseline). 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 26 Nov 2018.