Nutrition-Focused Quality Improvement Program (QIP) Among Community Dwelling Malnourished Patients

Completed

• Conditions: Malnutrition

• Registration Number: NCT04042987
• Lead Sponsor: Abbott Nutrition

Brief Summary

This study aims to assess the malnutrition prevalence of Colombian community-dwelling adults and evaluate the feasibility of a nutrition-focused QIP implemented in a Colombian ambulatory care facility on healthcare utilization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-02
• Study Start: 2019-09-10
• Primary Completion: 2020-03-19
• Study Completion: 2020-06-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1325

Inclusion Criteria

• Patient is screened as being malnourished or at risk for malnutrition
• Patient can consumer beverages and food orally
• Patients have a life expectancy of equal or greater than 90 days
• Patient is literate and willing to voluntarily sign and date an Informed Consent Form (ICF) after it is explained

Exclusion Criteria

• Patient is pregnant
• Patient is intubated, receiving tube feeding or parenteral nutrition
• Patient has severe dementia, delirium or history of significant psychiatric disorder and no dedicated caregiver who could assure their compliance with QIP study requirements and help with the completion of QIP study materials
• Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures
• Patient has an allergy or intolerance to any of the ONS ingredients
• Patients does not want to participate or sign ICF
• Patient is bedridden or confined in a wheelchair

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Malnutrition	Change from Baseline to Week 10 post-QIP enrollment	Measured by the Mini Nutritional Assessment (MNA®) a maximum 30 point scale resulting in a single Malnutrition Indicator Score where lower number indicates malnutrition

Secondary Outcome Measures

Name	Time	Method
Healthcare Resource Utilization	10-weeks follow-up period post enrollment from ambulatory care facility	Chart Review

Trial Locations

Locations (1)

Geriatric Unit. Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana; 🇨🇴 Bogota,, Colombia