MalnutritionNCT04042987
Nutrition-Focused Quality Improvement Program (QIP) Among Community Dwelling Malnourished Patients
An observational study of Malnutrition, run by Abbott Nutrition at 1 site in Colombia.
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. 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
- 1,325 participants
- Where
- 1 siteColombia
- Study dates
- 10 Sep 2019to 12 Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Sites will recruit patients for QIP group at discharge from hospital (after 3 months) or in ambulatory care facility.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Geriatric Unit. Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana
Bogotá
About this study
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
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.
- 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 Control Group | Retrospective chart review | |
| Prospective QIP Group | Participants that meet eligibility criteria will be prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline to Week 10 post-QIP enrollment
Secondary outcomes (1)
Healthcare Resource Utilization
Chart Review
Measured: 10-weeks follow-up period post enrollment from ambulatory care facility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start10 Sep 2019
- Primary completion19 Mar 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 1,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Suela Sulo, PhD, MSc, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042987
- Sponsor's protocol ID
- HA38
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gomez G, Botero-Rodriguez F, Misas JD, Garcia-Cifuentes E, Sulo S, Brunton C, Venegas-Sanabria LC, Gracia DA, Cano Gutierrez CA. A nutritionally focused program for community-living older adults resulted in improved health and well-being. Clin Nutr. 2022 Jul;41(7):1549-1556. doi: 10.1016/j.clnu.2022.05.003. Epub 2022 May 13.
PubMed 35667271Chavarro-Carvajal DA, Ayala AM, Venegas-Sanabria LC, Gomez G, Sulo S, Misas JD, Cano-Gutierrez C. Use of a nutrition-focused quality improvement program for community-living older adults at malnutrition risk is associated with better nutritional outcomes. Clin Nutr ESPEN. 2022 Apr;48:291-297. doi: 10.1016/j.clnesp.2022.01.032. Epub 2022 Feb 2.
PubMed 35331504
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04042987
- Acronym / sponsor ID
- HA38
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,325 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 2 Aug 2019 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical Control Group | – | –Retrospective chart review |
| Prospective QIP Group | – | –Participants that meet eligibility criteria will be prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sites will recruit patients for QIP group at discharge from hospital (after 3 months) or in ambulatory care facility.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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
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
1 secondary outcome
Healthcare Resource Utilization
Time frame: 10-weeks follow-up period post enrollment from ambulatory care facility
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 5 Oct 2020.
- Derived from this study: PubMed 35667271Gomez G, Botero-Rodriguez F, Misas JD, Garcia-Cifuentes E, Sulo S, Brunton C, Venegas-Sanabria LC, Gracia DA, Cano Gutierrez CA. A nutritionally focused program for community-living older adults resulted in improved health and well-being. Clin Nutr. 2022 Jul;41(7):1549-1556. doi: 10.1016/j.clnu.2022.05.003. Epub 2022 May 13.
- Derived from this study: PubMed 35331504Chavarro-Carvajal DA, Ayala AM, Venegas-Sanabria LC, Gomez G, Sulo S, Misas JD, Cano-Gutierrez C. Use of a nutrition-focused quality improvement program for community-living older adults at malnutrition risk is associated with better nutritional outcomes. Clin Nutr ESPEN. 2022 Apr;48:291-297. doi: 10.1016/j.clnesp.2022.01.032. Epub 2022 Feb 2.
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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 Colombia.
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 4 inclusion and 7 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 5 Oct 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 Colombia. 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?
Prevalence of Malnutrition (time frame: Change from Baseline to Week 10 post-QIP enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042987, which also lists 2 linked publications.
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 5 Oct 2020.