- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185585
Validation of a Comprehensive Older Adult Screening Tool (COAST) (COAST)
March 29, 2018 updated by: University of Florida
Development and Validation of a Comprehensive Older Adult Screening Tool (COAST)
The COAST nutrition screening tool will be validated in 300 community-dwelling older adults in Florida.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The population to be studied (n=300) will be individuals who are 60 years or older and participate in congregate meal sites or other community groups in Florida.
Demographic information will be collected and participants will be assessed by the MNA® (Mini Nutrition Assessment) and screened by the COAST nutrition screening tool.
Participants' hand grip strength and performance on the five times Sit to Stand test will be used to evaluate their functional status.
Weight, height, mid-arm circumference and calf circumference will be measured as part of the MNA screening tool.
Study Type
Observational
Enrollment (Actual)
301
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Older adults who attend congregate meal sites and other community groups in Florida will be recruited.
Description
Inclusion Criteria:
- Community-dwelling adults 60 years and older.
Exclusion Criteria:
- Non-English speaking/reading
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults 60 yrs and older
Participants will be asked to take the full MNA and COAST tools, separately .They will take a hand grip strength test to evaluate their functional status and five times Sit to Stand test as part of the COAST screening tool.
Moreover, their weight, height, mid-arm circumference and calf circumference, will be measured as part of the MNA screening tool.
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MNA® is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition.
Develop a comprehensive older adults screening tool for community dwelling older adults who attend congregate meal sites to assist in the evaluation of undernourishment or those at risk that is simple, faster, and less expensive
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
At Risk of Malnutrition
Time Frame: 1 year
|
Number of subjects with an MNA® score of < 23.5
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip strength
Time Frame: 1 year
|
Number of subjects with clinical weakness (<16 kg women; <26 kg men)
|
1 year
|
|
COAST
Time Frame: 1 year
|
Association of COAST score to MNA® at risk of malnutrition
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2017
Primary Completion (Actual)
November 27, 2017
Study Completion (Actual)
March 27, 2018
Study Registration Dates
First Submitted
June 9, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 14, 2017
Study Record Updates
Last Update Posted (Actual)
March 30, 2018
Last Update Submitted That Met QC Criteria
March 29, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB201701083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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