- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582202
Organization of the Dietetic Service in a Hospital
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult
- acutely admitted to hospital
Exclusion Criteria:
- dementia
- unable to comply with the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dietetic service
Nutritional assessment and therapy by dietitian throughout the hospital stay
|
Nutritional screening, nutritional plan, follow-up and instructions on discharge
|
|
Placebo Comparator: standard care
Nutritional handling by nurses supported by a dietician if needed
|
Nutritional handling by nurse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
re-admission-rate after discharge (%)
Time Frame: 2 months
|
admission for the same diagnosis
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intake of protein during hospital stay
Time Frame: 1 week
|
% of estimated needs
|
1 week
|
|
intake of energy during hospital stay
Time Frame: 1 week
|
% of estimated needs
|
1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-15004856
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malnutrition
-
Mairaj NoorCompletedMalnutrition (Calorie) | Protein-energy MalnutritionPakistan
-
Centre hospitalier Henri Mondor d'AurillacNot yet recruitingMalnutrition Severe | Malnutrition; ModerateFrance
-
HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
-
University of ExeterRecruitingMalnutrition Elderly | Protein MalnutritionUnited Kingdom
-
Erasmus Medical CenterNot yet recruitingMalnutrition or Risk of MalnutritionNetherlands
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; Stanford UniversityCompletedMalnutrition | Malnutrition in Children | Child MalnutritionBangladesh
-
University of Nove de JulhoUnknownMalnutrition, ChildBrazil
-
UNICEFSave the ChildrenCompletedSevere MalnutritionCongo, The Democratic Republic of the
-
Singapore Institute of Food and Biotechnology InnovationNot yet recruitingMalnutrition or Risk of Malnutrition | Anorexia of AgingSingapore
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteRecruitingModerate Acute Malnutrition | Severe Acute MalnutritionEthiopia
Clinical Trials on Nutritional assessment and therapy
-
Duke UniversityNational Cancer Institute (NCI)CompletedDepression | Breast Cancer | Fatigue | Malnutrition | Prostate Cancer | Psychosocial Effects of Cancer and Its TreatmentUnited States
-
City of Hope Medical CenterPatient-Centered Outcomes Research Institute; National Cancer Institute (NCI)Active, not recruitingMalignant Solid Neoplasm | Digestive System Carcinoma | Malignant Female Reproductive System Neoplasm | Genitourinary System CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCancer SurvivorUnited States
-
Lille Catholic UniversityCompletedNutrition Disorders | SARS-CoVFrance
-
Société Francophone d'Onco-GériatrieUnknownCancer | Malnutrition | ElderlyFrance
-
University of BariCompletedGastrostomy | Neuro-Degenerative Disease | Nutritional DeficiencyItaly
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingNutrition Assessment
-
Ankara Ataturk Sanatorium Training and Research...RecruitingPostoperative Complications | Lung Cancer | Nutrition, HealthyTurkey
-
Assiut UniversityNot yet recruitingUndernutrition | Malnutrition (Calorie) | Mucopolysaccharidosis (MPS)
-
Coordinación de Investigación en Salud, MexicoNational Council of Science and Technology, MexicoCompleted