Malnutrition Clinical Trial
Official title:
Assessing the Impact of A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients in an Academic University Hospital in Vietnam
NCT number | NCT03679832 |
Other study ID # | HA32 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 21, 2019 |
Est. completion date | October 11, 2019 |
Verified date | March 2020 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study includes pre and post-Quality Improvement Program groups. A nutrition-focused Quality Improvement Program will be implemented to assess the health and economic outcomes in malnourished hospitalized patients.
Status | Completed |
Enrollment | 1670 |
Est. completion date | October 11, 2019 |
Est. primary completion date | October 11, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is at risk / malnourished, defined by an MST score = 2 the first 24 hours post hospital admission - Patients are admitted for the following diagnoses: Respiratory, Digestive Surgery, Cardiology, General Internal Medicine (including Endocrinology), and Gastrointestinal - Patient is able to consume foods and beverages orally - Patients with life expectancy = 30 days - Patient is literate and willing to voluntarily sign and date Informed Consent Form (ICF) Exclusion Criteria: - Subject has severe dementia or delirium and has no dedicated caregiver who could assure their compliance with QIP study requirements - Subject has an eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures - Subject is known to be allergic or intolerant to any ingredient found in the study products - Subject is pregnant - Subject is intubated, receiving tube feeding or parenteral nutrition |
Country | Name | City | State |
---|---|---|---|
Vietnam | University Medical Center | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition | University Medical Center, Vietnam |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital Length of Stay | Chart Review | From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge) | |
Secondary | Healthcare Resource Utilization | Chart Review | Hospital Admission to 30-day Post Discharge |
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