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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412695
• Other study ID #: 2016/1464
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: July 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo university hospital, Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight (kg) during hospital stay	Measured standing on an electronic scale	2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)
Secondary	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	At the day of patient discharge (on day 11)
Secondary	Change in body Composition	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)
Secondary	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.	Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Secondary	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.	Assessed from medical journals every second day during each patient's hospital stay (11 days on average)
Secondary	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	Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)
Secondary	Re-admissions	Unplanned re-admissions	30 days after discharge
Secondary	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	Measured on day 1 and at admission (day 11 on average)