Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04675229 |
| Other study ID # |
ORE#42827 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2022 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of Waterloo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
