OPTIMAL in NH Residents With Dementia

NCT05255068 | Completed Results

• 1 other identifier: K23AG066856
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies.

Conditions

Alzheimer's Disease and Related Dementias

Keywords

Alzheimer's Disease and Related Dementias; Mealtime; Eating; Behavioral Symptoms; Food Intake; Function; Nutrition; Nursing Homes

Outcome Measures

Primary Outcomes (8)

• Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice

  All staff participants were interviewed on whether the intervention protocol and training materials were acceptable and appropriate for nursing home mealtime care practice before pilot testing.

  After recruitment of staff participants and before T1 (baseline)

• Number of Staff and Resident Participants Recruited and Retained for the Study

  The number of staff and resident participants that were recruited at baseline and retained over the study period were collected to indicate the feasibility of the study on participant recruitment, consent and retention.

  From recruitment/consent throughout the study completion, up to 12-weeks post baseline

• The Number of Staff Participants Who Attended All Training Sessions

  A checklist was used to track the number of staff participants who attended all the group and/or individual training sessions that were provided in the study.

  During each OPTIMAL training session (within 2 weeks post baseline)

• Staff Person-centered Care Knowledge and Self-efficacy

  Training receipt, indicated by a total score of ≥ 75% on the staff PCMC-related knowledge \& self-efficacy test post-training with or without booster sessions. The total score of the scale ranges from 0 - 20, and higher scores are better. we recorded the number of staff who reached this cutoff score post training.

  Right before and after OPTIMAL training session (within 2 weeks post baseline)

• Number of Staff Participants Who Viewed the Intervention Was Useful

  All staff participants were interviewed on whether the intervention was useful post testing. The number of staff participants who viewed the intervention was useful was collected.

  After T3 data collection time point (12-weeks post baseline)

• The Number of Mealtime Difficulty Behaviors Observed in Residents

  Videos will be coded using the Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme that have codes for resident mealtime difficulties including 1) resistive behaviors and 2) functional impairments. we recorded the number of behaviors representing mealtime difficulties presented by residents, the higher the number, the worse the outcome.

  T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)

• Resident Level of Eating Performance

  Level of Eating Independence Scale, a 9-item scale assessing the ability of independence with eating and drinking activities during cycles of verbal prompts, will be used to measure. Each item is scored from 1 (total dependence) to 4 (total independence), with total score ranging from 9 to 36 (higher score = more independence).

  T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)

• Resident Intake Success Rate

  Videos will be coded using CUED to track whether the resident or staff initiates/completes each intake attempt and whether there is a subsequent intake after each attempt. Resident intake success rate will be calculated by dividing the number of intake attempts initiated/completed by the resident with subsequent intake by the total number of intake attempts coded during one meal. the percent can range from 0 - 100%, the higher the number, the more independent the resident.

  T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)

Secondary Outcomes (2)

• Quality of Staff Engagement

  T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)

• Resident Body Mass Index (BMI).

  T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)

Study Arms (2)

Staff

EXPERIMENTAL

Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.

Behavioral: OPTIMAL

Resident

EXPERIMENTAL

Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.

Behavioral: OPTIMAL

Interventions

OPTIMAL BEHAVIORAL

A person-centered mealtime care intervention

Resident; Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents
• ≥ 55 years
• Diagnosed as having ADRD based on medical records
• Identified by NH staff as requiring mealtime assistance
• Having a legally authorized representative (LAR) providing informed written consent
• Staffs
• ≥18 years
• English speaking
• A permanent facility employee
• Provide direct mealtime care for a resident participant at least twice a week over the previous month
• Families
• ≥18 years
• English speaking
• A family member of the resident who is living at the NH study site at the time of the study
• Having experience of delivering mealtime care to their resident family members

You may not qualify if:

• Residents
• Have a documented diagnosis of Parkinson's disease, traumatic brain injury, or swallowing disorder,
• Do not eat orally (e.g., parenteral/IV feedings, feeding tubes)
• Unable to hear or see staff even with glasses and/or hearing aids (e.g., uncorrected visual or hearing impairment)
• Stay in the NH study site for less than 12 weeks at the time of recruitment/consent/assent (e.g., terminally ill receiving hospice services, and/or receiving post-hospital skilled rehabilitation) that may not allow enough time for obtaining consent/assent, and scheduling days for video recording sessions across three-time points (baseline, and 6- and 12- weeks post-baseline)

Sponsors & Collaborators

• University of Iowa: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Iowa Vateran's Home

Marshalltown, Iowa, 50158, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Behavioral Symptoms

Interventions

Optimal Pressed Ceramic

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Wen Liu
• Organization: The University of Iowa

wen-liu-1@uiowa.edu

3193557104

Study Officials

• Liu Wen, PhD

  The University Of Iowa College Of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Because this study is a single-group design, all participants were recruited from the nursing home site that was assigned as the intervention group. no one is blinded to the intervention assignment, but all participants and outcome assessors were blinded for the research questions/aims.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 24, 2022
• Study Start: May 16, 2022
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)