MalnutritionNCT03488329
Effect of Nutritional Efforts on Discharged Elderly Patients
A study testing Individual nutritional therapy in people with Malnutrition, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The study is a randomized controlled study, ongoing over 16 weeks. At discharge, the intervention group receives guidance from a clinical dietician, where an individual nutrition plan is made. The dietitian will perform a telephone follow-up after 4 and 30 days. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Individual nutritional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 1 Mar 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to Oncology, Gastro-medical / Surgical, and Medical Department, HGH, Herlev.
- Age: 50+
- At admission, found in nutritional risk score ≥3 according to NRS-2002.
- On special food concept, Herlev's Glories during hospitalization
- Discharged to own home in a municipality in Planområde Midt (Ballerup, Herlev, Lyngby-Tårbæk, Gentofte, Gladsaxe, Rødovre, Egedal, Rudersdal, Furesø).
- Can read, hear and understand Danish
- Cognitive able to participate in the study, based on whether they are informed in time, place and own data.
Who cannot join
- Food allergy or intolerance
- Planned weight loss or following a special diet
- Receives enteral or parenteral nutrition
- Patients with moderate to severe dysphagia, defined with a need for gratin or a creamy diet
- Patients who does not want a food package or goodiebag
- Patients who are permanently bedridden
Show all 10Show fewer
- Patients who are discharged to nursing homes or rehabilitation
- Patients in isolation
- Late palliative patients
- Terminal patients
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Unit for Dietetics and Nutrition Research, Herlev hosipital
Herlev, 2730
About this study
The study is a randomized controlled study, ongoing over 16 weeks. At discharge, the intervention group receives guidance from a clinical dietician, where an individual nutrition plan is made. The dietitian will perform a telephone follow-up after 4 and 30 days. It will also be possible for the participant, relatives or municipality to contact the dietician if nutritional questions arise.
At the time of discharge the intervention group will receive a package containing foods and drinks that will cover their nutritional needs the first day after discharge.
Read more
They will also get a goodiebag containing samples on protein-rich milk-based drinks. Data is collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, as well as experience of discharge and cooperation with the municipality.
If there is a need, information about nutrition status will be sent to the municipality so the municipality can take over nutritional treatment.
The control group receives standard treatment.
- Conditions
- Malnutrition
- Being tested
- Individual nutritional therapy
- Keywords
- Hospital readmissions, Seniors
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual nutritional therapyDietary supplement
Guidance from a clinical dietician.
Individual nutrition plan
A package containing foods and drinks, which will cover their nutritional needs the first day after discharge.
A goodiebag containing samples on protein-rich milk-based drinks.
Telephone follow-up after 4 and 30 days and the possibility to call the dietician in case of questions about nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group
Individual nutritional therapy Receives: Dietary Supplement: Individual nutritional therapy |
| Control | No intervention | Control group Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmissions
Measured: 6 months
Secondary outcomes (9)
Mortality
Measured: 30 days, 16 weeks, 6 months
Weight
Measured: 16 weeks
Protein intake
24 hour recall
Measured: 16 weeks
Energi Intake
24 hour recall
Measured: 16 weeks
Appetite
SNAQ
Measured: 16 weeks
Health related Quality of life
EQ-5D
Measured: 16 weeks
Physical function
30-s CST
Measured: 16 weeks
Hospital readmissions
Measured: 30 days, 16 weeks
Combined adverse advents
Measured: 30 days, 16 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 May 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Anias Svendsen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488329
- Sponsor's protocol ID
- 2007-58-0015
- Status last verified
- Jan 2021
- First submitted
- 15 Feb 2018
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Thomsen T, Olesen SS, Rasmussen HH, Beck AM. A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5500-5510. doi: 10.1016/j.clnu.2021.09.029. Epub 2021 Sep 24.
PubMed 34656032Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Beck AM. Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial. Trials. 2020 Apr 28;21(1):365. doi: 10.1186/s13063-020-04301-6.
PubMed 32345358
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Efforts on Discharged Elderly Patients
- ClinicalTrials.gov ID
- NCT03488329
- Acronym / sponsor ID
- 2007-58-0015
- Conditions
- Malnutrition
- Keywords
- Hospital readmissions, Seniors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Apr 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 study is a randomized controlled study, ongoing over 16 weeks. At discharge, the intervention group receives guidance from a clinical dietician, where an individual nutrition plan is made. The dietitian will perform a telephone follow-up after 4 and 30 days. It will also be possible for the participant, relatives or municipality to contact the dietician if nutritional questions arise.
At the time of discharge the intervention group will receive a package containing foods and drinks that will cover their nutritional needs the first day after discharge.
They will also get a goodiebag containing samples on protein-rich milk-based drinks. Data is collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, as well as experience of discharge and cooperation with the municipality.
If there is a need, information about nutrition status will be sent to the municipality so the municipality can take over nutritional treatment.
The control group receives standard treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Individual nutritional therapyIntervention group Individual nutritional therapy |
| Control | No intervention | –Control group Standard treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients admitted to Oncology, Gastro-medical / Surgical, and Medical Department, HGH, Herlev.
- Age: 50+
- At admission, found in nutritional risk score ≥3 according to NRS-2002.
- On special food concept, Herlev's Glories during hospitalization
- Discharged to own home in a municipality in Planområde Midt (Ballerup, Herlev, Lyngby-Tårbæk, Gentofte, Gladsaxe, Rødovre, Egedal, Rudersdal, Furesø).
Key exclusion criteria (10 listed)
- Food allergy or intolerance
- Planned weight loss or following a special diet
- Receives enteral or parenteral nutrition
- Patients with moderate to severe dysphagia, defined with a need for gratin or a creamy diet
- Patients who does not want a food package or goodiebag
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 |
|---|---|---|
| Individual nutritional therapyGuidance from a clinical dietician. Individual nutrition plan A package containing foods and drinks, which will cover their nutritional needs the first day after discharge. A goodiebag containing samples on protein-rich milk-based drinks. Telephone follow-up after 4 and 30 days and the possibility to call the dietician in case of questions about nutrition. | Dietary supplement | Intervention |
Primary outcome
Hospital readmissions
Time frame: 6 months
9 secondary outcomes
Mortality
Time frame: 30 days, 16 weeks, 6 months
Weight
Time frame: 16 weeks
Protein intake
Time frame: 16 weeks
Energi Intake
Time frame: 16 weeks
Appetite
Time frame: 16 weeks
Health related Quality of life
Time frame: 16 weeks
Physical function
Time frame: 16 weeks
Hospital readmissions
Time frame: 30 days, 16 weeks
Combined adverse advents
Time frame: 30 days, 16 weeks, 6 months
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 6 Jan 2021.
- Derived from this study: PubMed 34656032Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Thomsen T, Olesen SS, Rasmussen HH, Beck AM. A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5500-5510. doi: 10.1016/j.clnu.2021.09.029. Epub 2021 Sep 24.
- Derived from this study: PubMed 32345358Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Beck AM. Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial. Trials. 2020 Apr 28;21(1):365. doi: 10.1186/s13063-020-04301-6.
- 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.
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?
A study testing Individual nutritional therapy in people with Malnutrition, run by Herlev Hospital at 1 site in Denmark.
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 7 inclusion and 10 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 6 Jan 2021. 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 Denmark. 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?
Hospital readmissions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488329, which also lists 2 linked publications.
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 6 Jan 2021.