Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition

July 30, 2019 updated by: Mari Mohn Paulsen, Oslo University Hospital
The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system "MyFood" which can be used to assess patients' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. The investigators will study the clinical effects of using MyFood among hospitalized patients. In addition the implementation of the tool among healthcare workers will be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. Disease-related malnutrition increase the morbidity and mortality among patients and leads to longer length of stay. There is a lack of tools to follow up the nutritional treatment of patients at nutritional risk. The decision support system "MyFood" is developed in the project with the purpose to prevent and treat disease-related malnutrition. MyFood includes 4 modules: 1) A function to register patient needs and symptoms, 2) Dietary assessment function, 3) Automatic evaluation of dietary intake compared to individual needs, 4) Feedback, including a report on intake of energy, protein, and liquids compared to individual needs, and recommendations for nutritional measures and an individual nutrition plan.

Clinical effects of using MyFood among hospitalized patients will be studied in a randomized controlled trial. In addition, the implementation of the tool among nurses and other healthcare workers will be explored.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0372
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Exclusion Criteria:

  • <72 hours expected hospital stay
  • Terminal patients
  • Pregnant
  • Psychiatric patients
  • Patients who cannot read the Norwegian Language
  • Patients diagnosed with: sickle cell anemia, haemophilia, or deep vein thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
Use of the MyFood tool among patients and nurses (intervention group)
Device: MyFood
Patients included in the intervention group will use the MyFood app to record their dietary intake. Nurses will use the report and recommendations in the MyFood tool to follow up the nutritional treatment of the patients.
NO_INTERVENTION: Arm B
No intervention. Regular hospital routines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight (kg) during hospital stay
Time Frame: 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Measured standing on an electronic scale
2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient length of hospital stay
Time Frame: At the day of patient discharge (on day 11)
Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group
At the day of patient discharge (on day 11)
Change in body Composition
Time Frame: 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Fat free mass, muscle mass, fat mass, and phase angle. Measured by bioelectrical impedance analysis.
2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Proportion of patients who receives a nutrition diagnose
Time Frame: Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Number of patients who receives a nutrition diagnose (E46.00) will be measured among patients participating in the study. Proportion of patients who receives a nutrition diagnose in the intervention group will be compared with the proportion of patients who receives a nutrition diagnose in the control group.
Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Proportion of patients who get implemented nutrition-related measures
Time Frame: Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
The decision support system gives recommendations for nutritional-related measures, based on individual symptoms and dietary intake compared to needs.
Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Proportion of patients who receive a nutrition plan
Time Frame: Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)
According to the national guidelines all patients at nutritional risk should have an individual nutrition plan. The decision support system will generate a suggested nutrition plan, based on information recorded in the system. Proportion of patients in the intervention group who receives a nutrition plan, compared to proportion in the control group will be measured
Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)
Re-admissions
Time Frame: 30 days after discharge
Unplanned re-admissions
30 days after discharge
Patient generated subjective global assessment (PG-SGA) score
Time Frame: Measured on day 1 and at admission (day 11 on average)
The patient generated subjective global assessment (PG-SGA) is a form including questions on weight development, food intake, symptoms, and activity level and function
Measured on day 1 and at admission (day 11 on average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 22, 2018

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

May 31, 2019

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (ACTUAL)

January 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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