ADMIRE: Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05536830
Collaborator
(none)
120
1
12
10

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nutrition Status

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Sep 14, 2023
Anticipated Study Completion Date :
Sep 14, 2023

Arms and Interventions

Arm 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.

Other: Nutrition Status
Participants will be examined by a registered dietitian to assess nutrition status.

Outcome Measures

Primary Outcome Measures

  1. Nutrition status of persons with dementia [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."

  2. Nutrition literacy of caregivers [1 week]

    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.

  3. Nutrition status of caregivers [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).

Secondary Outcome Measures

  1. Perceived nutrition needs of informal caregivers of persons with dementia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center

Investigators

  • Principal Investigator: Heather D Gibbs, PhD, RD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heather Gibbs, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT05536830
Other Study ID Numbers:
  • 148085
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 13, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Heather Gibbs, Associate Professor, University of Kansas Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2022