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Organization of the Dietetic Service in a Hospital

Primary Purpose

Nutritional Disease, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional assessment and therapy
Standard care
Sponsored by
Jens Rikardt Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutritional Disease focused on measuring dietitic service, organization of service

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult
  • acutely admitted to hospital

Exclusion Criteria:

  • dementia
  • unable to comply with the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Dietetic service

    standard care

    Arm Description

    Nutritional assessment and therapy by dietitian throughout the hospital stay

    Nutritional handling by nurses supported by a dietician if needed

    Outcomes

    Primary Outcome Measures

    re-admission-rate after discharge (%)
    admission for the same diagnosis

    Secondary Outcome Measures

    intake of protein during hospital stay
    % of estimated needs
    intake of energy during hospital stay
    % of estimated needs

    Full Information

    First Posted
    June 18, 2018
    Last Updated
    July 12, 2018
    Sponsor
    Jens Rikardt Andersen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03582202
    Brief Title
    Organization of the Dietetic Service in a Hospital
    Official Title
    Organization of the Dietetic Service in a Hospital - on the Ward or Centralized?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 18, 2015 (Actual)
    Primary Completion Date
    April 25, 2016 (Actual)
    Study Completion Date
    April 22, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jens Rikardt Andersen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutritional Disease, Malnutrition
    Keywords
    dietitic service, organization of service

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled
    Masking
    Outcomes Assessor
    Masking Description
    Results handled without knowledge of randomization group
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dietetic service
    Arm Type
    Active Comparator
    Arm Description
    Nutritional assessment and therapy by dietitian throughout the hospital stay
    Arm Title
    standard care
    Arm Type
    Placebo Comparator
    Arm Description
    Nutritional handling by nurses supported by a dietician if needed
    Intervention Type
    Procedure
    Intervention Name(s)
    Nutritional assessment and therapy
    Intervention Description
    Nutritional screening, nutritional plan, follow-up and instructions on discharge
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard care
    Intervention Description
    Nutritional handling by nurse
    Primary Outcome Measure Information:
    Title
    re-admission-rate after discharge (%)
    Description
    admission for the same diagnosis
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    intake of protein during hospital stay
    Description
    % of estimated needs
    Time Frame
    1 week
    Title
    intake of energy during hospital stay
    Description
    % of estimated needs
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adult acutely admitted to hospital Exclusion Criteria: dementia unable to comply with the protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jens R Andersen
    Organizational Affiliation
    University of Copenhagen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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