- 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
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