Community-dwelling Older AdultsCOASTNCT03185585
Validation of a Comprehensive Older Adult Screening Tool (COAST)
An observational study of Community-dwelling Older Adults, run by University of Florida at 1 site in United States.
Trial summary
The COAST nutrition screening tool will be validated in 300 community-dwelling older adults in Florida. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Community-dwelling Older Adults
- What is being tested?
- Mini Nutrition Assessment (MNA® ) and Comprehensive Older Adult Screening Tool (COAST)
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 27 Mar 2018
- 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 60 to 100 years
- All sexes
- Adult, Older adult
Study population: Older adults who attend congregate meal sites and other community groups in Florida will be recruited.
Who may be able to join
- Community-dwelling adults 60 years and older.
Who cannot join
- Non-English speaking/reading
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Community-dwelling Older Adults
- Being tested
- Mini Nutrition Assessment (MNA® ), Comprehensive Older Adult Screening Tool (COAST)
- Keywords
- Nutritional screenings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Nutrition Assessment (MNA® )Other
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.
Comprehensive Older Adult Screening Tool (COAST)Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mini Nutrition Assessment (MNA® ); Other: Comprehensive Older Adult Screening Tool (COAST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
At Risk of Malnutrition
Number of subjects with an MNA® score of < 23.5
Measured: 1 year
Secondary outcomes (2)
Handgrip strength
Number of subjects with clinical weakness (<16 kg women; <26 kg men)
Measured: 1 year
COAST
Association of COAST score to MNA® at risk of malnutrition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start13 Jun 2017
- Primary completion27 Nov 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-dwelling Older AdultsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy J Dahl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185585
- Sponsor's protocol ID
- IRB201701083
- Acronym
- COAST
- Status last verified
- Mar 2018
- First submitted
- 9 Jun 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Comprehensive Older Adult Screening Tool (COAST)
- ClinicalTrials.gov ID
- NCT03185585
- Acronym / sponsor ID
- COAST / IRB201701083
- Conditions
- Community-dwelling Older Adults
- Keywords
- Nutritional screenings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 14 Jun 2017 (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.
The COAST nutrition screening tool will be validated in 300 community-dwelling older adults in Florida.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults 60 yrs and older | – | Other: Mini Nutrition Assessment (MNA® ), Other: Comprehensive Older Adult Screening Tool (COAST)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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Older adults who attend congregate meal sites and other community groups in Florida will be recruited.
Key inclusion criteria (1 listed)
- Community-dwelling adults 60 years and older.
Key exclusion criteria (1 listed)
- Non-English speaking/reading
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini Nutrition Assessment (MNA® )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. | Other | Adults 60 yrs and older |
| Comprehensive Older Adult Screening Tool (COAST)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 | Other | Adults 60 yrs and older |
Primary outcome
At Risk of Malnutrition
Time frame: 1 year
Number of subjects with an MNA® score of < 23.5
2 secondary outcomes
Handgrip strength
Time frame: 1 year
COAST
Time frame: 1 year
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 30 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Wendy J Dahl, PhD principal investigator
University of Florida
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 Community-dwelling Older Adults, run by University of Florida at 1 site in United States.
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 1 inclusion and 1 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 30 Mar 2018. 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 United States. 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?
At Risk of Malnutrition (time frame: 1 year). 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 30 Mar 2018.