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

Malnutrition Clinical Trial

Official title:

Assessing Malnutrition Prevalence and Impact of a Nutrition-Focused Quality Improvement Program (QIP) Among Community-Dwelling Malnourished Colombian Patients Receiving Care in an Ambulatory Health Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042987
• Other study ID #: HA38
• Status: Completed
• Start date: September 10, 2019
• Est. completion date: June 12, 2020

Study information

• Verified date: October 2020
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1325
• Est. completion date: June 12, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
Colombia	Geriatric Unit. Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana	Bogota,

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Nutrition	Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index (BMI)	BMI calculated Weight (kg)/Height (m)2	Baseline and Week 10 post-QIP enrollment
Other	Calf Circumference (CC)	Measurement at largest circumference of calf	Baseline and Week 10 post-QIP enrollment
Other	Short Physical Performance Battery (SPPB)	Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction	Baseline and Week 10 post-QIP enrollment
Other	Hand Grip	Participant assessed with hand dynamometers	Baseline and Week 10 post-QIP enrollment
Other	Quality of Life EuroQOL EQ-5D	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	Baseline and Week 10 post-QIP
Other	Nutritional Supplement Consumption	Participant reported	Baseline and Week 10 post-QIP
Primary	Prevalence of Malnutrition	Measured by the Mini Nutritional Assessment (MNA®) a maximum 30 point scale resulting in a single Malnutrition Indicator Score where lower number indicates malnutrition	Change from Baseline to Week 10 post-QIP enrollment
Secondary	Healthcare Resource Utilization	Chart Review	10-weeks follow-up period post enrollment from ambulatory care facility