MalnutritionMCCNCT02182427
Malnutrition Clinical Characteristics Validation Study
An observational study of Malnutrition, run by Academy of Nutrition and Dietetics at 4 sites in 2 countries.
Trial summary
Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 54 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2014to Oct 2015
- How long will I take part?
- 30 Days
- 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: All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to one of the following acute care facilities: University Hospitals Case Medical Center, Cleveland Clinic, and St. John's Westshore in Cleveland, Ohio, United States, and Princess Alexandra Hospital in Brisbane, Queensland, Australia.
Who may be able to join
- Patient on inpatient dietitian consult list
- Able to speak English to answer questions
- Ability to provide informed consent (or provided by family member)
- Expected remaining admission time > 24 hours (determined by no mention of pending discharge in physicians notes)
- Age ≥ 18 years
Who cannot join
- Seen previously by Registered Dietitian during current admission
- Patient on hospice or palliative care, in a psychiatric, maternity, pediatric or day surgery area, or in dedicated trauma or burn unit.
- Life expectancy <7 days per physician note or Registered Dietitian (RD) judgment
- Participated in the study during a previous admission
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
St. John's West Shore Hospital
Westlake, Ohio, 44145
About this study
Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. The goal of this project is to determine whether these characteristics are the best indicators to identify malnutrition or if there are other factors that may better identify malnutrition. Because there is no gold standard definition for malnutrition, the investigators will compare the characteristics against outcomes such as length of stay, hospital readmission and death. Outcomes are also influenced by disease state, therefore, information on what brought the patient to the hospital and what happened to them in the hospital will be collected that allows the investigators to separate the effect of malnutrition from disease. The hypothesis for this study is that the malnutrition clinical characteristics and diagnosis criteria, as presented by the experts, are valid and reliable principles for the diagnosis of adult under-nutrition.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed with and without malnutrition using the MCC.
Measured: 30-days post-discharge
Secondary outcomes (1)
30-day readmission rate among study participants
Measured: Within 90 days after data collection is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Academy of Nutrition and Dietetics
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Parenteral and Enteral Nutrition
- Responsible party
- Principal investigator, Alison Steiber, Academy of Nutrition and Dietetics
- Investigators
- Alison Steiber, Principal investigator, Academy of Nutrition and DieteticsMaree Ferguson, Study chair, Princess Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182427
- Sponsor's protocol ID
- 2014-Pilot
- Acronym
- MCC
- Status last verified
- Jan 2016
- First submitted
- 1 Jul 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy of Nutrition and Dietetics Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). J Acad Nutr Diet. 2012 May;112(5):730-8. doi: 10.1016/j.jand.2012.03.012. Epub 2012 Apr 25.
PubMed 22709779
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition Clinical Characteristics Validation Study
- ClinicalTrials.gov ID
- NCT02182427
- Acronym / sponsor ID
- MCC / 2014-Pilot
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Academy of Nutrition and DieteticsUniversity, hospital or other
- Collaborators
- American Society for Parenteral and Enteral Nutrition
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Jul 2014 (estimated)
- 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.
Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. The goal of this project is to determine whether these characteristics are the best indicators to identify malnutrition or if there are other factors that may better identify malnutrition. Because there is no gold standard definition for malnutrition, the investigators will compare the characteristics against outcomes such as length of stay, hospital readmission and death. Outcomes are also influenced by disease state, therefore, information on what brought the patient to the hospital and what happened to them in the hospital will be collected that allows the investigators to separate the effect of malnutrition from disease. The hypothesis for this study is that the malnutrition clinical characteristics and diagnosis criteria, as presented by the experts, are valid and reliable principles for the diagnosis of adult under-nutrition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to one of the following acute care facilities: University Hospitals Case Medical Center, Cleveland Clinic, and St. John's Westshore in Cleveland, Ohio, United States, and Princess Alexandra Hospital in Brisbane, Queensland, Australia.
Key inclusion criteria (5 listed)
- Patient on inpatient dietitian consult list
- Able to speak English to answer questions
- Ability to provide informed consent (or provided by family member)
- Expected remaining admission time > 24 hours (determined by no mention of pending discharge in physicians notes)
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Seen previously by Registered Dietitian during current admission
- Patient on hospice or palliative care, in a psychiatric, maternity, pediatric or day surgery area, or in dedicated trauma or burn unit.
- Life expectancy <7 days per physician note or Registered Dietitian (RD) judgment
- Participated in the study during a previous admission
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
Number of participants diagnosed with and without malnutrition using the MCC.
Time frame: 30-days post-discharge
1 secondary outcome
30-day readmission rate among study participants
Time frame: Within 90 days after data collection is complete
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 27 Jan 2016.
- Background: PubMed 22709779White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy of Nutrition and Dietetics Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). J Acad Nutr Diet. 2012 May;112(5):730-8. doi: 10.1016/j.jand.2012.03.012. Epub 2012 Apr 25.
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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.
Alison Steiber principal investigator
Academy of Nutrition and Dietetics
Maree Ferguson study chair
Princess Alexandra Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Academy of Nutrition and Dietetics at 4 sites in 2 countries.
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 4 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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?
Number of participants diagnosed with and without malnutrition using the MCC. (time frame: 30-days post-discharge). 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 NCT02182427, which also lists 1 linked publication.
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 27 Jan 2016.