Clinical trial NCT04675229: Extending the Validation of SCREEN to Persons Living with Dementia or in Retirement Homes
Official title: Extending the Validation and Reliability Testing of SCREEN: a Nutrition Risk Screening Tool for Community-living Seniors
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Malnutrition
Nutrition Poor
Dementia
Keywords: nutrition risk
dementia
retirement
validity
reliability
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-12-19
Enrollment: 600
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons living with dementia who have a family care partner Persons living in a retirement home

Brief 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 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) 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* living in a nursing home
* do not speak or read English
* have MCI-D but do not have a caregiver to participate
* live outside of the geographic boundaries of this study (i.e., \> 45 km from Kitchener/Waterloo or London).

Primary outcomes:
measure: Validity of SCREEN
timeFrame: 3 years
measure: Reliability of SCREEN
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Heather Keller
state: Ontario
Study officials:
affiliation: U Waterloo
name: Heather Keller
role: PRINCIPAL_INVESTIGATOR
References: