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.
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.
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.
- Conditions
- Malnutrition, Nutrition Poor, Dementia
- 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.
Validity of SCREEN
Comparison of SCREEN to a dietitian's assessment
Measured: 3 years
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.
- First posted19 Dec 2020
- Study start25 Sep 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Heather Keller, University of Waterloo
- Investigators
- Heather Keller, Principal investigator, U Waterloo
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending the Validation and Reliability Testing of SCREEN: A Nutrition Risk Screening Tool for Community-living Seniors
- ClinicalTrials.gov ID
- NCT04675229
- Acronym / sponsor ID
- SCREEN / ORE#42827
- Conditions
- Malnutrition, Nutrition Poor, Dementia
- Keywords
- nutrition risk, dementia, retirement, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 25 Sep 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 19 Dec 2020 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
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
Validity of SCREEN
Time frame: 3 years
Comparison of SCREEN to a dietitian's assessment
Reliability of SCREEN
Time frame: 3 years
Test-retest reliability
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 28 Apr 2026.
- Individual participant dataSharing planned: Yes. Repository at University of Waterloo
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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.
Heather Keller principal investigator
U Waterloo
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 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.