NCT03582202

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

June 18, 2018

Last Update Submit

July 12, 2018

Conditions

Keywords

dietitic service, organization of service

Outcome Measures

Primary Outcomes (1)

  • re-admission-rate after discharge (%)

    admission for the same diagnosis

    2 months

Secondary Outcomes (2)

  • intake of protein during hospital stay

    1 week

  • intake of energy during hospital stay

    1 week

Study Arms (2)

Dietetic service

ACTIVE COMPARATOR

Nutritional assessment and therapy by dietitian throughout the hospital stay

Procedure: Nutritional assessment and therapy

standard care

PLACEBO COMPARATOR

Nutritional handling by nurses supported by a dietician if needed

Procedure: Standard care

Interventions

Nutritional screening, nutritional plan, follow-up and instructions on discharge

Dietetic service
Standard carePROCEDURE

Nutritional handling by nurse

standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult
  • acutely admitted to hospital

You may not qualify if:

  • dementia
  • unable to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nutrition DisordersMalnutrition

Interventions

Nutrition AssessmentTherapeuticsStandard of Care

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthQuality Indicators, Health CareHealth Services Administration

Study Officials

  • Jens R Andersen

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Results handled without knowledge of randomization group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 10, 2018

Study Start

April 18, 2015

Primary Completion

April 25, 2016

Study Completion

April 22, 2017

Last Updated

July 16, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share