Malnutrition
Conditions
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.
Interventions
None listed
Sponsors
Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Resource Utilization | 10-weeks follow-up period post enrollment from ambulatory care facility | Chart Review |
Other
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery (SPPB) | Baseline and Week 10 post-QIP enrollment | Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction |
| Hand Grip | Baseline and Week 10 post-QIP enrollment | Participant assessed with hand dynamometers |
| Body mass index (BMI) | Baseline and Week 10 post-QIP enrollment | BMI calculated Weight (kg)/Height (m)2 |
| Nutritional Supplement Consumption | Baseline and Week 10 post-QIP | Participant reported |
| Quality of Life EuroQOL EQ-5D | Baseline and Week 10 post-QIP | Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction |
| Calf Circumference (CC) | Baseline and Week 10 post-QIP enrollment | Measurement at largest circumference of calf |
Countries
Colombia
Outcome results
None listed