- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05536830
Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers (ADMIRE)
April 10, 2025 updated by: Heather Gibbs, University of Kansas Medical Center
Nutrition is critical for disease prevention and brain health.
Malnutrition and weight loss often affect persons with Alzheimer's dementia (PWD), worsening overall health and dementia.
Informal caregivers (usually family members) perform many nutrition-related tasks as part of daily care such as food preparation and feeding.
Limited research, however, suggests informal caregivers experience high rates of caregiver burden, malnutrition and low health literacy.
More research is needed to uncover these and other factors that may contribute to malnutrition for both PWDs and their caregivers.
Nutrition literacy, or ability to navigate nutrition information to select healthy food, may be an important caregiving factor that protects both individuals from experiencing nutritional decline.
Although the NIH has increased funding to support caregiver research, caregiver interventions that include nutrition are lacking.
The purpose of this study is to inform the design of a future nutrition intervention study.
Study Overview
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited as caregiver-patient dyads, and both must fit the inclusion and exclusion criteria.
Description
Inclusion Criteria:
- Person with dementia: Must be an adult of any age, diagnosed with Alzheimer's dementia or other dementia, reside at home with a family caregiver or domestic partner, and have weight records at a minimum of 2 timepoints.
- Caregiver: Must be at least 18 years old, English speaking, primary caregiver who is responsible for food planning, and no overt cognitive impairment.
Exclusion Criteria:
- Person with dementia: Frontal-temporal dementia, alcohol-related dementia, Huntington's disease, schizophrenia, manic-depressive disorder, or actively participating in nutrition intervention research.
- Caregiver: Visual impairments that prevent completing questionnaires or actively participating in nutrition intervention research.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participant dyads: Caregivers and Care Recipients
Participants will be recruited in pairs as caregivers and care recipients.
All data collected is observational in nature.
|
Participants will be examined by a registered dietitian to assess nutrition status.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrition status of persons with dementia
Time Frame: 1 month
|
Nutrition status will be assessed by registered dietitians, using the Mini-Nutrition Assessment (score ranges 0 to 18) and Subjective Global Assessment (score ranges 0-7).
Scores of each measure are further categorized into "normal," "at risk of malnutrition," or "malnourished."
|
1 month
|
|
Nutrition literacy of caregivers
Time Frame: 1 week
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Nutrition literacy will be measured by the Nutrition Literacy Assessment Instrument (score ranges 0 to 42).
Scores are interpreted as: >39 good, 29-38: moderate, ≤ 28: poor.
|
1 week
|
|
Nutrition status of caregivers
Time Frame: 1 month
|
Nutrition status of caregivers will be measured using the Mini Nutrition Assessment (MNA) tool (18-item version).
Scoring is Normal (12-14 pts), At risk of malnutrition (8-11 pts), or Malnourished (0-7 points).
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived nutrition needs of informal caregivers of persons with dementia
Time Frame: 1 week
|
Researchers will use interviews, surveys, and focus groups to collect the thoughts of caregivers and clinic care providers to anticipate needs for a future caregiver intervention.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Heather D Gibbs, PhD, RD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2022
Primary Completion (Actual)
December 8, 2023
Study Completion (Actual)
December 8, 2024
Study Registration Dates
First Submitted
September 7, 2022
First Submitted That Met QC Criteria
September 7, 2022
First Posted (Actual)
September 13, 2022
Study Record Updates
Last Update Posted (Actual)
April 15, 2025
Last Update Submitted That Met QC Criteria
April 10, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 148085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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