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MalnutritionSCREENNCT04675229

Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes

An observational study of Malnutrition and Nutrition Poor, run by University of Waterloo at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Older adults (≥ 55 years) who do not eat enough nutritious food are at risk of malnutrition. Malnutrition can lead to frailty, hospitalization, poor quality of life, and death. SCREEN (Seniors in the Community Risk Evaluation for Eating and Nutrition) is the leading nutrition risk screening tool for cognitively well… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Malnutrition, Nutrition Poor, Dementia
How many people
326 participants
Where
1 siteCanada
Study dates
25 Sep 2022to 31 Aug 2025
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 55 years and older
  • All sexes
  • Adult, Older adult

Study population: Persons living with diagnosed dementia Persons with subjective complaint for memory and MoCA < 26 Persons living in a retirement home

Who may be able to join

  • 55 years of age or older
  • potential participants with MCI-D will have a caregiver who either lives with the participant or is in daily contact OR
  • potential participants have subjective complaint - MoCA used to confirm cogntive change OR
  • Retirement home participants will have lived in their residence for a minimum of 3 months
  • read and communicate in English
  • provide written consent or assent for persons MCI-D; caregiver written consent required if participant with cognitive change unable to provide

Who cannot join

  • living in a nursing home
  • do not speak or read English
  • live outside of the geographic boundaries of this study (i.e., > 45 km from Kitchener/Waterloo or London).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Heather Keller

    Guelph, Ontario

Other trials in Canada

About this study

Official title: Extending the Validation and Reliability Testing of SCREEN: A Nutrition Risk Screening Tool for Community-living Seniors

Older adults (≥ 55 years) who do not eat enough nutritious food are at risk of malnutrition. Malnutrition can lead to frailty, hospitalization, poor quality of life, and death. SCREEN (Seniors in the Community Risk Evaluation for Eating and Nutrition) is the leading nutrition risk screening tool for cognitively well older adults living in the community. The purpose of this study is to determine if SCREEN can be used to find nutrition risk among older adults diagnosed with mild cognitive impairment or dementia (i.e., MCI-D) or those with a MoCA < 26 living in the community and persons living in retirement homes.

SCREEN and other nutrition and health measures will be completed in 600 older adults (300 living in retirement homes with or without MCI-D, and 300 living with MCI-D in the community). SCREEN will be completed twice to determine reliability, and persons with MCI-D will have their results compared to those of a caregiver who completes it on their behalf. A dietitian's assessment and rating of nutrition risk will be used as the gold-standard to determine validity.

Read the detailed description

About a third of cognitively well, community-living older Canadians are at nutrition risk, which has been shown to lead to hospitalizations, poor quality of life, and death. Since SCREEN was created 20 years ago, there has been considerable growth in the number of community-living older adults diagnosed with mild cognitive impairment or dementia (i.e., MCI-D) and/or living in retirement homes. These two groups are nutritionally vulnerable. Nutrition risk is specifically associated with the progression of cognitive impairment and frailty, as well as caregiver burden. Yet, these groups are under-served with respect to nutrition care; dietitian services are not available in retirement homes and limited in many primary or memory care clinics. Nutrition screening and subsequent management of identified nutrition problems by accessing diverse community services (e.g., meal programs) in Canadian older adults is recommended because it can promote independence and delay frailty. However, preventative management for those with MCI-D or living in retirement homes is limited by lack of systematic nutrition screening with a valid and reliable tool that is feasible for these vulnerable seniors.

SCREEN is the leading nutrition risk tool for community-living seniors and is the logical choice for use in those with MCI-D and/or living in retirement residences. However, it has not been validated in these groups. It cannot be assumed that the existing validation in cognitively well older adults living in their own homes can translate to these two vulnerable groups. As well, one question on grocery shopping needs to be changed to accommodate persons living in retirement homes. This study is also timely with the recent update of Canada's Food Guide and recommendations to increase protein intake to mitigate frailty. Two questions on SCREEN need to be modified to adapt the new language on protein foods used in the new Food Guide. This study will undertake the validation and reliability testing of SCREEN, considering these minor revisions, in 600 older adults (community-dwelling older adults with MCI-D and those living in retirement homes with or without MCI-D). Validation of SCREEN for these populations will ensure that a single tool can be used in all older adults living in community and retirement settings. Specifically, understanding at what point a person with MCI-D is no longer a reliable informant for completing SCREEN will help with identification when a caregiver should complete the questionnaire. This is why the Montreal Cognitive Assessment is used, as it provides discrete scores differentiating mild cognitive impairment from dementia. The results of this study will have significant impact on practice by allowing, for the first time, confidence in the identification of nutrition risk in these under-served groups in Canada. There is an urgent need for this research. Early identification of nutrition risk and its subsequent management has the potential to advance our health care system by promoting the prevention of frailty and its consequences. This study will have a meaningful impact in the 'real world' setting of primary and community care for older adults in Canada and worldwide, by providing a feasible, validated and useful nutrition risk tool.

Keywords
nutrition risk, dementia, retirement, validity, reliability
Medical subject headings
Malnutrition, Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validity of SCREEN

    Comparison of SCREEN to a dietitian's assessment

    Measured: 3 years

  2. Reliability of SCREEN

    Test-retest reliability

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start25 Sep 2022
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04675229
Sponsor's protocol ID
ORE#42827
Acronym
SCREEN
Status last verified
Feb 2026
First submitted
14 Dec 2020
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Repository at University of Waterloo

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition and Nutrition Poor, run by University of Waterloo at 1 site in Canada.

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 6 inclusion and 3 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 28 Apr 2026. 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 Canada. 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?

Validity of SCREEN (time frame: 3 years). The study lists 2 primary outcomes in all. 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 28 Apr 2026.

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