MalnutritionNutrikerNCT04244851
Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission
An observational study of Malnutrition, run by Rennes University Hospital at 1 site in France.
Trial summary
Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Malnourished patients
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2020to 12 Apr 2021
- 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: Malnourished patients diagnosed during their hospitalization in the post-emergency unit of Rennes Universisty Hospital
Who may be able to join
- Malnourished patients, hospitalized in the post-emergency unit during the study period, according to the malnutrition diagnostic criteria defined by the French Health Authority :
- age ≥ 70 years old: weight loss ≥ 5% within 1 month or ≥ 10% within 6 months and/or BMI <21 and or serum albumin level < 35 g/l
- age < 70 years old : weight loss ≥ 5% in 1 month or ≥ 10% in 6 months or ≥ 10% compared to the usual weight before the onset of the disease; or BMI <18.5 kg / m2
- Non-inclusion criteria :
- refusing to participate in the study
- age < 18 years old
Show all 9Show fewer
- patients under tutorship or guardianship
- patients living in retirement home
- Patients without a fixed address
Who cannot join
- -patients transferred in another unit
Trial locations and contacts
1 site in 1 country.
About this study
Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.
This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.
Read the detailed description
All patients hospitalized in the post-emergency unit of Rennes University Hospital during the study period will be screened for malnutrition.
Data concerning newly diagnosed malnourished patients will be recorded and those patients will be contacted 3 months after their hospital discharge.
A qualitative study will be conducted among malnourished patients and their families : a sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.
- Conditions
- Malnutrition
- Being tested
- Malnourished patients
- Keywords
- Malnutrition,, qualitative study
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malnourished patientsOther
Data of included patients will be recorded during hospitalization using medical charts.
Every patient will be contacted by phone 3 months after hospital discharge. A sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.
| Study group | Role | What they receive |
|---|---|---|
| Malnourished patients | Malnourished patients Receives: Other: Malnourished patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of malnutrition after hospital discharge
Malnutrition diagnostic criteria defined by the French Health Authority :
- If age ≥ 70 years old : weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI < 21 kg/m² and/or serum albumin level < 35 g/l
- If age < 70 years old: weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI < 18,5 kg/m² level
Measured: 3 months after discharge
Secondary outcomes (7)
Describe the path of care following the hospitalization of patients diagnosed with malnutrition at the hospital
- Number of hospital readmissions
- Number of family physician consultations
Measured: 3 months after discharge
Evaluate appropriation of patient regarding malnutrition
Qualitative study by semi-structured patient interviews
Measured: 3 months after discharge
Evaluate the perception of patient regarding malnutrition
Qualitative study by semi-structured patient interviews
Measured: 3 months after discharge
Evaluate expectations of patient regarding malnutrition
Qualitative study by semi-structured patient interviews
Measured: 3 months after discharge
Evaluate the needs of health professionals regarding undernutrition
Qualitative study by semi-structured patient interviews
Measured: 3 months after discharge
Evaluate the expectations of health professionals regarding undernutrition
Qualitative study by semi-structured patient interviews
Measured: 3 months after discharge
Evaluate knowledge of health professionals regarding undernutrition
Qualitative study by semi-structured patient interviews
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start4 Feb 2020
- Primary completion4 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244851
- Sponsor's protocol ID
- 35RC19_30034_NUTRIKer
- Other IDs
- 2019-A01809-48
- Acronym
- Nutriker
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2019
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission
- ClinicalTrials.gov ID
- NCT04244851
- Acronym / sponsor ID
- Nutriker / 35RC19_30034_NUTRIKer
- Conditions
- Malnutrition
- Keywords
- Malnutrition,, qualitative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 4 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 28 Jan 2020 (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.
Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.
This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.
Detailed description
All patients hospitalized in the post-emergency unit of Rennes University Hospital during the study period will be screened for malnutrition.
Data concerning newly diagnosed malnourished patients will be recorded and those patients will be contacted 3 months after their hospital discharge.
A qualitative study will be conducted among malnourished patients and their families : a sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malnourished patients | – | Other: Malnourished patientsMalnourished patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Malnourished patients diagnosed during their hospitalization in the post-emergency unit of Rennes Universisty Hospital
Key inclusion criteria (9 listed)
- Malnourished patients, hospitalized in the post-emergency unit during the study period, according to the malnutrition diagnostic criteria defined by the French Health Authority :
- age ≥ 70 years old: weight loss ≥ 5% within 1 month or ≥ 10% within 6 months and/or BMI <21 and or serum albumin level < 35 g/l
- age < 70 years old : weight loss ≥ 5% in 1 month or ≥ 10% in 6 months or ≥ 10% compared to the usual weight before the onset of the disease; or BMI <18.5 kg / m2
- refusing to participate in the study
- age < 18 years old
Key exclusion criteria (1 listed)
- -patients transferred in another unit
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 |
|---|---|---|
| Malnourished patientsData of included patients will be recorded during hospitalization using medical charts. Every patient will be contacted by phone 3 months after hospital discharge. A sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition. | Other | Malnourished patients |
Primary outcome
evolution of malnutrition after hospital discharge
Time frame: 3 months after discharge
Malnutrition diagnostic criteria defined by the French Health Authority : * If age ≥ 70 years old : weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI < 21 kg/m² and/or serum albumin level < 35 g/l * If age < 70 years old: weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI < 18,5 kg/m² level
7 secondary outcomes
Describe the path of care following the hospitalization of patients diagnosed with malnutrition at the hospital
Time frame: 3 months after discharge
Evaluate appropriation of patient regarding malnutrition
Time frame: 3 months after discharge
Evaluate the perception of patient regarding malnutrition
Time frame: 3 months after discharge
Evaluate expectations of patient regarding malnutrition
Time frame: 3 months after discharge
Evaluate the needs of health professionals regarding undernutrition
Time frame: 3 months after discharge
Evaluate the expectations of health professionals regarding undernutrition
Time frame: 3 months after discharge
Evaluate knowledge of health professionals regarding undernutrition
Time frame: 3 months after discharge
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 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Malnutrition, run by Rennes University Hospital 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 9 inclusion and 1 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 12 Jun 2026. 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?
evolution of malnutrition after hospital discharge (time frame: 3 months after discharge). 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 12 Jun 2026.