Skip to main content
OpenTrials
Completed

NCT Number: NCT03412695

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo university hospital, Rikshospitalet

Oslo, 0372, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyFood

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.