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OpenTrials
Completed

NCT Number: NCT04042987

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

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geriatric Unit. Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of Malnutrition

    Time frame: 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 outcomes

  1. Healthcare Resource Utilization

    Time frame: 10-weeks follow-up period post enrollment from ambulatory care facility

    Chart Review

Other outcomes

  1. Body mass index (BMI)

    Time frame: Baseline and Week 10 post-QIP enrollment

    BMI calculated Weight (kg)/Height (m)2

  2. Calf Circumference (CC)

    Time frame: Baseline and Week 10 post-QIP enrollment

    Measurement at largest circumference of calf

  3. Short Physical Performance Battery (SPPB)

    Time frame: Baseline and Week 10 post-QIP enrollment

    Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction

  4. Hand Grip

    Time frame: Baseline and Week 10 post-QIP enrollment

    Participant assessed with hand dynamometers

  5. Quality of Life EuroQOL EQ-5D

    Time frame: 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

  6. Nutritional Supplement Consumption

    Time frame: Baseline and Week 10 post-QIP

    Participant reported

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Collaborators

  • Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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