MalnutritionNCT03679832
A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients
An observational study of Malnutrition, run by Abbott Nutrition at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- Type of treatment
- Pill or oral medicine
- How many people
- 1,670 participants
- Where
- 1 siteVietnam
- Study dates
- 21 Mar 2019to 11 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted to a single-site in Vietnam meeting eligibility criteria for retrospective or prospective participation.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impact of A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients in an Academic University Hospital in Vietnam
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.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Historical Group 1 | Patients admitted at UMC between September 2015 and October 2016 | |
| Historical Group 2 | Patients admitted at UMC between November 2016 and up to the beginning of the QIP | |
| Nutrition-Focused QIP | Patients admitted at UMC that meet eligibility criteria and prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption 30-days post discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Chart Review
Measured: From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge)
Secondary outcomes (1)
Healthcare Resource Utilization
Chart Review
Measured: Hospital Admission to 30-day Post Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start21 Mar 2019
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center, Vietnam
- Responsible party
- Sponsor
- Investigators
- Suela Sulo, PhD,MSc, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679832
- Sponsor's protocol ID
- HA32
- Status last verified
- Mar 2020
- First submitted
- 17 Aug 2018
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients in an Academic University Hospital in Vietnam
- ClinicalTrials.gov ID
- NCT03679832
- Acronym / sponsor ID
- HA32
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,670 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- University Medical Center, Vietnam
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Historical Group 1 | – | –Patients admitted at UMC between September 2015 and October 2016 |
| Historical Group 2 | – | –Patients admitted at UMC between November 2016 and up to the beginning of the QIP |
| Nutrition-Focused QIP | – | –Patients admitted at UMC that meet eligibility criteria and prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption 30-days post discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a single-site in Vietnam meeting eligibility criteria for retrospective or prospective participation.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital Length of Stay
Time frame: From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge)
Chart Review
1 secondary outcome
Healthcare Resource Utilization
Time frame: Hospital Admission to 30-day Post Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suela Sulo, PhD,MSc study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Abbott Nutrition at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.