Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02182427




Registration number
NCT02182427
Ethics application status
Date submitted
1/07/2014
Date registered
8/07/2014
Date last updated
27/01/2016

Titles & IDs
Public title
Malnutrition Clinical Characteristics Validation Study
Scientific title
Malnutrition Clinical Characteristics Validation Study
Secondary ID [1] 0 0
2014-Pilot
Universal Trial Number (UTN)
Trial acronym
MCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants diagnosed with and without malnutrition using the MCC.
Timepoint [1] 0 0
30-days post-discharge
Secondary outcome [1] 0 0
30-day readmission rate among study participants
Timepoint [1] 0 0
Within 90 days after data collection is complete

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Other
Name
Academy of Nutrition and Dietetics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American Society for Parenteral and Enteral Nutrition
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alison Steiber
Address 0 0
Academy of Nutrition and Dietetics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02182427