MalnutritionNCT05299541
Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life
A study testing Food dish, Indirect calorimetric and Bioimpedance in people with Malnutrition and Quality of Life, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Malnutrition, Quality of Life
- What is being tested?
- Food dish, Indirect calorimetric and Bioimpedance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Apr 2017to 11 Jan 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MUST =>2
- Region of living Bney-Brak or Petah-tikwa
- Fine cognitive state
Who cannot join
- Progressive cancer
- Dementia
- Fiddling by PEG or Enteral nutrient via Naso gastric tube
- Psychiatrics disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Support in Patients Who Have Been Diagnosed at Nutritional Risk in the Hospital and Discharged Home. How we Can Improved the Prognosis and Quality of Life.
Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life.
Patients and Methods: 60 discharged patients suffering from nutritional (MUST>2) and financial frailty were included. Control group (C) took their regular nutrition at home for 6 months and study group (S) received a daily dinner tray sponsored by the municipality. Hazalla philanthropic organization encouraged the patients at lunch for 6 months. Body composition (Quadstat 4000, Bodystat, UK), energy requirements (Fitmate- COSMED, Italy) were measured at recruitement. Primary outcome was 180 days survival. In addition, in the recruitment stage and after a period of 3 and 6 months, depression and anxiety questionnaire (HADS), quality of Life Questionnaire-SF36and FIM questionnaire - designed to examine the level of independence of patients with disability were performed at days 0, 90 and 180. Statistical analysis used T- Test and ANOVA Repeated Measures. The study was approved by local IRB.
- Conditions
- Malnutrition, Quality of Life
- Being tested
- Food dish, Indirect calorimetric, Bioimpedance, Questioners, Plated food dish
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food dishDietary supplement
All patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months
Group A - will receive a dish of food every evening by a person employed by a rescue organization for 6 months
At the end of the meal once a week
- All dishes will be photographed at the end of the meal by Android camera, iPhone
- A NUTRITION DAY success photo form will be completed and collected .
Indirect calorimetricDiagnostic test
- The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
BioimpedanceDiagnostic test
- The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
QuestionersBehavioural
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given:
HADS, Quality of life 36SF and FIM
Plated food dishDietary supplement
All patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months Group b - will receive a food dish every evening by a person employed by a rescue organization with improved appearance of a plate for 6 months.
At the end of the meal once a week
- All dishes will be photographed at the end of the meal by Android camera, iPhone
- A NUTRITION DAY success photo form will be completed and collected .
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Measurements and questioners Receives: Diagnostic Test: Indirect calorimetric; Diagnostic Test: Bioimpedance; Behavioral: Questioners |
| Group A | Active comparator | Receiving Food dish every night for 6 months Measurements and questioners Receives: Dietary Supplement: Food dish; Diagnostic Test: Indirect calorimetric; Diagnostic Test: Bioimpedance; Behavioral: Questioners |
| Group B | Active comparator | Receiving Food dish every night for 6 months, at this group extra attention have given to the dish plating and appearance by professional (BOCUSE), Measurements and questioners Receives: Diagnostic Test: Indirect calorimetric; Diagnostic Test: Bioimpedance; Behavioral: Questioners; Dietary Supplement: Plated food dish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve quality of life
HADS questionnaire (hospital anxiety ans depression scale), scale 0-21. 0-7: normal; 8-10: borderline; 11-21: abnormal.
Measured: 6 months
Improve quality of life
FIM questionnaire (functional indepence measure) scale 0 to 7, 1= total asistance, 7=complete independence, the highst score the best.
Measured: 6 months
Improve quality of life
sf-36 questionnaire (short form health survey), scale 0-100, the highest the score the less disability
Measured: 6 months
changed Mortality
six mounth follow up through ATD (American Trans Data Corp)
Measured: 6 months
changed financials costs per patient in health system
follow up through electronic medical records
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start2 Apr 2017
- Primary completion6 Aug 2020
- Study completion11 Jan 2021
Why it stopped: Difficulties recruiting new subjects
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Singer, Rabin Medical Center
- Investigators
- Pierre Singer, Prof, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299541
- Sponsor's protocol ID
- 0390-16-RMC
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Support in Patients Who Have Been Diagnosed at Nutritional Risk in the Hospital and Discharged Home. How we Can Improved the Prognosis and Quality of Life.
- ClinicalTrials.gov ID
- NCT05299541
- Acronym / sponsor ID
- 0390-16-RMC
- Conditions
- Malnutrition, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties recruiting new subjects
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 29 Mar 2022 (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.
Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life.
Patients and Methods: 60 discharged patients suffering from nutritional (MUST>2) and financial frailty were included. Control group (C) took their regular nutrition at home for 6 months and study group (S) received a daily dinner tray sponsored by the municipality. Hazalla philanthropic organization encouraged the patients at lunch for 6 months. Body composition (Quadstat 4000, Bodystat, UK), energy requirements (Fitmate- COSMED, Italy) were measured at recruitement. Primary outcome was 180 days survival. In addition, in the recruitment stage and after a period of 3 and 6 months, depression and anxiety questionnaire (HADS), quality of Life Questionnaire-SF36and FIM questionnaire - designed to examine the level of independence of patients with disability were performed at days 0, 90 and 180. Statistical analysis used T- Test and ANOVA Repeated Measures. The study was approved by local IRB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Diagnostic Test: Indirect calorimetric, Diagnostic Test: Bioimpedance, Behavioral: QuestionersMeasurements and questioners |
| Group A | Active comparator | Dietary Supplement: Food dish, Diagnostic Test: Indirect calorimetric, Diagnostic Test: Bioimpedance, Behavioral: QuestionersReceiving Food dish every night for 6 months Measurements and questioners |
| Group B | Active comparator | Diagnostic Test: Indirect calorimetric, Diagnostic Test: Bioimpedance, Behavioral: Questioners, Dietary Supplement: Plated food dishReceiving Food dish every night for 6 months, at this group extra attention have given to the dish plating and appearance by professional (BOCUSE), Measurements and questioners |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MUST =>2
- Region of living Bney-Brak or Petah-tikwa
- Fine cognitive state
Key exclusion criteria (4 listed)
- Progressive cancer
- Dementia
- Fiddling by PEG or Enteral nutrient via Naso gastric tube
- Psychiatrics disorder
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 |
|---|---|---|
| Food dishAll patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months Group A - will receive a dish of food every evening by a person employed by a rescue organization for 6 months At the end of the meal once a week * All dishes will be photographed at the end of the meal by Android camera, iPhone * A NUTRITION DAY success photo form will be completed and collected . | Dietary supplement | Group A |
| Indirect calorimetric• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement. | Diagnostic test | Control, Group A, Group B |
| Bioimpedance• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). . | Diagnostic test | Control, Group A, Group B |
| QuestionersAt 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given: HADS, Quality of life 36SF and FIM | Behavioural | Control, Group A, Group B |
| Plated food dishAll patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months Group b - will receive a food dish every evening by a person employed by a rescue organization with improved appearance of a plate for 6 months. At the end of the meal once a week * All dishes will be photographed at the end of the meal by Android camera, iPhone * A NUTRITION DAY success photo form will be completed and collected . | Dietary supplement | Group B |
Primary outcome
Improve quality of life
Time frame: 6 months
HADS questionnaire (hospital anxiety ans depression scale), scale 0-21. 0-7: normal; 8-10: borderline; 11-21: abnormal.
Improve quality of life
Time frame: 6 months
FIM questionnaire (functional indepence measure) scale 0 to 7, 1= total asistance, 7=complete independence, the highst score the best.
Improve quality of life
Time frame: 6 months
sf-36 questionnaire (short form health survey), scale 0-100, the highest the score the less disability
changed Mortality
Time frame: 6 months
six mounth follow up through ATD (American Trans Data Corp)
changed financials costs per patient in health system
Time frame: 6 months
follow up through electronic medical records
Results and safety
The study was stopped early (reason given: Difficulties recruiting new subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- 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.
Pierre Singer, Prof principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food dish, Indirect calorimetric and Bioimpedance in people with Malnutrition and Quality of Life, run by Rabin Medical Center at 1 site in Israel.
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 4 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: stopped early, as of the sponsor's last update on 29 Mar 2022. 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 Israel. 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 was stopped early (reason given: Difficulties recruiting new subjects). Results are not available in the source record.
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?
Improve quality of life (time frame: 6 months). The study lists 5 primary outcomes in all. 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 29 Mar 2022.