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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2020
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Vietnam University Medical Center Ho Chi Minh City

Sponsors (2)

Lead Sponsor Collaborator
Abbott Nutrition University Medical Center, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

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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