Nutritional DiseaseNCT03582202
Organization of the Dietetic Service in a Hospital
A study testing Nutritional assessment and therapy in people with Nutritional Disease and Malnutrition, run by Jens Rikardt Andersen.
Trial summary
In Denmark the dieticians can be organized centrally and called upon if needed, or locally in larger units, or very locally related to bed-units. The organization form is based on tradition not on measurements of quality. We wanted to compare the very local form with the traditional centralized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Disease, Malnutrition
- What is being tested?
- Nutritional assessment and therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2015to 22 Apr 2017
- 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
- adult
- acutely admitted to hospital
Who cannot join
- dementia
- unable to comply with the protocol
About this study
Official title: Organization of the Dietetic Service in a Hospital - on the Ward or Centralized?
In Denmark the dieticians can be organized centrally and called upon if needed, or locally in larger units, or very locally related to bed-units. The organization form is based on tradition not on measurements of quality. We wanted to compare the very local form with the traditional centralized.
Methods: Randomized, unblinded, parallel design. The intervention group (IT) was nutritionally handled by the dietician, and the control group (C) by the nurses as previously with the possibility for dietetic help from the center.
Read the detailed description
All patients were screened by NRS-2002 and had their estimated needs calculated (equations in IT, tables in C). The IT was in addition assessed for adapted weight-loss, counseled with a plan for nutrition and followed-up daily by the dietician if at nutritional risk. All patients were re-screened weekly and had their intake registered. Hand-grib-strength (HGS) was measured in both groups at admittance and discharge, and weight three times weekly.
The primary endpoint was re-admission rate to hospital within 2 months.
- Conditions
- Nutritional Disease, Malnutrition
- Being tested
- Nutritional assessment and therapy, Standard care
- Keywords
- dietitic service, organization of service
- Medical subject headings
- Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional assessment and therapyProcedure or surgery
Nutritional screening, nutritional plan, follow-up and instructions on discharge
Standard careProcedure or surgery
Nutritional handling by nurse
| Study group | Role | What they receive |
|---|---|---|
| Dietetic service | Active comparator | Nutritional assessment and therapy by dietitian throughout the hospital stay Receives: Procedure: Nutritional assessment and therapy |
| standard care | Placebo comparator | Nutritional handling by nurses supported by a dietician if needed Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-admission-rate after discharge (%)
admission for the same diagnosis
Measured: 2 months
Secondary outcomes (2)
intake of protein during hospital stay
% of estimated needs
Measured: 1 week
intake of energy during hospital stay
% of estimated needs
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start18 Apr 2015
- Primary completion25 Apr 2016
- Study completion22 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582202
- Sponsor's protocol ID
- H-15004856
- Status last verified
- Jul 2018
- First submitted
- 18 Jun 2018
- Last updated
- 16 Jul 2018
- 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 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organization of the Dietetic Service in a Hospital - on the Ward or Centralized?
- ClinicalTrials.gov ID
- NCT03582202
- Acronym / sponsor ID
- H-15004856
- Conditions
- Nutritional Disease, Malnutrition
- Keywords
- dietitic service, organization of service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Study start
- 18 Apr 2015 (actual)
- Primary completion
- 25 Apr 2016 (actual)
- Study completion
- 22 Apr 2017 (actual)
- First posted
- 10 Jul 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.
In Denmark the dieticians can be organized centrally and called upon if needed, or locally in larger units, or very locally related to bed-units. The organization form is based on tradition not on measurements of quality. We wanted to compare the very local form with the traditional centralized.
Methods: Randomized, unblinded, parallel design. The intervention group (IT) was nutritionally handled by the dietician, and the control group (C) by the nurses as previously with the possibility for dietetic help from the center.
Detailed description
All patients were screened by NRS-2002 and had their estimated needs calculated (equations in IT, tables in C). The IT was in addition assessed for adapted weight-loss, counseled with a plan for nutrition and followed-up daily by the dietician if at nutritional risk. All patients were re-screened weekly and had their intake registered. Hand-grib-strength (HGS) was measured in both groups at admittance and discharge, and weight three times weekly.
The primary endpoint was re-admission rate to hospital within 2 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Dietetic service | Active comparator | Procedure: Nutritional assessment and therapyNutritional assessment and therapy by dietitian throughout the hospital stay |
| standard care | Placebo comparator | Procedure: Standard careNutritional handling by nurses supported by a dietician if needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult
- acutely admitted to hospital
Key exclusion criteria (2 listed)
- dementia
- unable to comply with the protocol
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 |
|---|---|---|
| Nutritional assessment and therapyNutritional screening, nutritional plan, follow-up and instructions on discharge | Procedure or surgery | Dietetic service |
| Standard careNutritional handling by nurse | Procedure or surgery | standard care |
Primary outcome
re-admission-rate after discharge (%)
Time frame: 2 months
admission for the same diagnosis
2 secondary outcomes
intake of protein during hospital stay
Time frame: 1 week
intake of energy during hospital stay
Time frame: 1 week
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 16 Jul 2018.
- 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.
Jens R Andersen principal investigator
University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional assessment and therapy in people with Nutritional Disease and Malnutrition, run by Jens Rikardt Andersen.
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 2 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 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
re-admission-rate after discharge (%) (time frame: 2 months). 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 16 Jul 2018.