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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412695
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Mari Mohn Paulsen, Oslo University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malnutrition Device: MyFood Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
Actual Study Start Date : August 22, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Re-admissions [ Time Frame: 30 days after discharge ]
    Unplanned re-admissions

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412695


Locations
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Norway
Oslo university hospital, Rikshospitalet
Oslo, Norway, 0372
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mari Mohn Paulsen, Project coordinator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03412695    
Other Study ID Numbers: 2016/1464
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mari Mohn Paulsen, Oslo University Hospital:
Disease-related malnutrition
eHealth
Decision support system
Clinical nutrition
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders