Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
MyFood
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring Disease-related malnutrition, eHealth, Decision support system, Clinical nutrition
Eligibility 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
Sites / Locations
- Oslo university hospital, Rikshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A
Arm B
Arm Description
Use of the MyFood tool among patients and nurses (intervention group)
No intervention. Regular hospital routines
Outcomes
Primary Outcome Measures
Change in body weight (kg) during hospital stay
Measured standing on an electronic scale
Secondary Outcome Measures
Patient length of hospital stay
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
Change in body Composition
Fat free mass, muscle mass, fat mass, and phase angle. Measured by bioelectrical impedance analysis.
Proportion of patients who receives a nutrition diagnose
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.
Proportion of patients who get implemented nutrition-related measures
The decision support system gives recommendations for nutritional-related measures, based on individual symptoms and dietary intake compared to needs.
Proportion of patients who receive a nutrition plan
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
Re-admissions
Unplanned re-admissions
Patient generated subjective global assessment (PG-SGA) score
The patient generated subjective global assessment (PG-SGA) is a form including questions on weight development, food intake, symptoms, and activity level and function
Full Information
NCT ID
NCT03412695
First Posted
January 10, 2018
Last Updated
July 30, 2019
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT03412695
Brief Title
Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
Official Title
Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Disease-related malnutrition, eHealth, Decision support system, Clinical nutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Use of the MyFood tool among patients and nurses (intervention group)
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
No intervention. Regular hospital routines
Intervention Type
Device
Intervention Name(s)
MyFood
Intervention Description
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 Outcome Measure Information:
Title
Change in body weight (kg) during hospital stay
Description
Measured standing on an electronic scale
Time Frame
2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Secondary Outcome Measure Information:
Title
Patient length of hospital stay
Description
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
Time Frame
At the day of patient discharge (on day 11)
Title
Change in body Composition
Description
Fat free mass, muscle mass, fat mass, and phase angle. Measured by bioelectrical impedance analysis.
Time Frame
2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Title
Proportion of patients who receives a nutrition diagnose
Description
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.
Time Frame
Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Title
Proportion of patients who get implemented nutrition-related measures
Description
The decision support system gives recommendations for nutritional-related measures, based on individual symptoms and dietary intake compared to needs.
Time Frame
Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Title
Proportion of patients who receive a nutrition plan
Description
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
Time Frame
Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)
Title
Re-admissions
Description
Unplanned re-admissions
Time Frame
30 days after discharge
Title
Patient generated subjective global assessment (PG-SGA) score
Description
The patient generated subjective global assessment (PG-SGA) is a form including questions on weight development, food intake, symptoms, and activity level and function
Time Frame
Measured on day 1 and at admission (day 11 on average)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Oslo university hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33766017
Citation
Paulsen MM, Varsi C, Andersen LF. Process evaluation of the implementation of a decision support system to prevent and treat disease-related malnutrition in a hospital setting. BMC Health Serv Res. 2021 Mar 25;21(1):281. doi: 10.1186/s12913-021-06236-3.
Results Reference
derived
PubMed Identifier
32241711
Citation
Paulsen MM, Paur I, Gjestland J, Henriksen C, Varsi C, Tangvik RJ, Andersen LF. Effects of using the MyFood decision support system on hospitalized patients' nutritional status and treatment: A randomized controlled trial. Clin Nutr. 2020 Dec;39(12):3607-3617. doi: 10.1016/j.clnu.2020.03.012. Epub 2020 Mar 19.
Results Reference
derived
Learn more about this trial
Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition
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