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OPTIMAL in NH Residents With Dementia

Primary Purpose

Alzheimer's Disease and Related Dementias

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OPTIMAL
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease and Related Dementias focused on measuring Alzheimer's Disease and Related Dementias, Mealtime, Eating, Behavioral Symptoms, Food Intake, Function, Nutrition, Nursing Homes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The investigators will recruit direct care staff (N=20), families of residents (N=20), and residents with dementia (N=20) from NH sites following the exclusion and inclusion criteria after attrition rates are considered.

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

  • Iowa Vateran's Home

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm1

Arm Description

OPTIMAL

Outcomes

Primary Outcome Measures

Acceptability of OPTIMAL
One separate focus group interview of staff and families, respectively, in each NH will be conducted following an interview guide to prioritize the multiple mealtime difficulties identified from literature and to explore their perceptions of the acceptability and areas of refinement of the intervention protocol and training materials.
Feasibility data on identification, recruitment, consent, and retention of staff, residents, and family participant
19 questions will be asked to assess the feasibility data on identification, recruitment, consent, and retention.
Staff attendance to training sessions
Delivery of training, tracking staff's attendance at the group or individual training sessions using a checklist
Changes of staff PCMC-related knowledge and self-efficacy between pre- and post-OPTIMAL training
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
Change from baseline staff use of PCMC-related strategies at 6 weeks and 12 weeks
The validated Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme capturing both verbal and nonverbal behaviors that address staff person-centered and task-centered mealtime care strategies will be used to code video-recorded observations collected from the proposed study. Briefly, codes for verbal behaviors in CUED include 8 positive behaviors and 4 negative behaviors. Nonverbal behaviors include 7 negative behaviors and 13 positive behaviors in 3 categories: 1) modification of resident eating ability represented by 5 behaviors (e.g., "adjusting pace"), 2) modification of care approaches represented by 3 behaviors (e.g., "adjusting proximity"), and 3) modification of dining environment represented by 5 behaviors (e.g., "reducing clutter").
Usefulness of OPTIMAL
Staff perceived usefulness of the OPTIMAL intervention (OPTIMAL group) or OPTIMAL training session (education control group) will be assessed using semi-structured focus group interviews.
Change from baseline resident mealtime difficulties at 6 weeks and 12 weeks
Videos will be coded using CUED that have codes for resident mealtime difficulties grouped in three categories: 1) chewing or swallowing difficulties represented by 4 nonverbal behaviors, 2) functional impairment represented by 5 nonverbal behaviors, and 3) resistive behaviors represented by 6 nonverbal behaviors.
Change from baseline resident eating performance at 6 weeks and 12 weeks
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.
Change from baseline resident intake success rate at 6 weeks and 12 weeks
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.

Secondary Outcome Measures

Quality of staff engagement
Quality of staff engagement will be assessed by Mealtime Engagement Scale developed by the PI with evidence of reliability and validity.
Resident body weight in killograms
Bodyweight will be measured in the early morning before breakfast with each individual resident dressing casual indoor clothes without shoes using the same digital body scale throughout the study. The investigators will assess body weight twice in one early morning of each time point and calculate the average of the two assessments.

Full Information

First Posted
January 17, 2022
Last Updated
February 15, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT05255068
Brief Title
OPTIMAL in NH Residents With Dementia
Official Title
Optimizing Mealtime Care (OPTIMAL): Development and Pilot Testing of a Person-Centered Mealtime Care Intervention for Nursing Home Residents With Alzheimer's Disease and Related Dementias (ADRD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
November 5, 2022 (Actual)
Study Completion Date
November 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies. The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. First, the investigators will develop OPTIMAL through systematic integration of four PCMC principles, prior work on multilevel facilitators and barriers to engaging residents in eating, and our systematic review of mealtime difficulties and targeted behavioral strategies. The investigators will use mixed methods (i.e., focus groups, a pilot two-group parallel cluster RCT) to refine and test OPTIMAL. The investigators will enroll staff (N=20), families of residents (N=20), and residents (N=20) in nursing homes (NHs). Participants will be randomly assigned to one of two treatment groups: 1) OPTIMAL (i.e., training sessions, ongoing mentoring, biweekly facilitations), and 2) education control (i.e., training sessions only). In each treatment group, data will be collected at 3-time points: baseline (T1), immediately post-intervention (6 weeks post-baseline, T2), and 6-week post-intervention (12 weeks post-baseline, T3). At each time point, the investigators will assess the quality of staff engagement and resident outcomes and collect videotaped observations of dyadic mealtime interaction (videos) over 6 meals in 2 consecutive days (2 breakfasts, 2 lunches, 2 dinners) for each staff-resident dyad. The investigators will use Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme, an innovative, feasible, and reliable tool that our team has developed and validated, to assess a) staff PCMC&TCMC behaviors, b) resident mealtime difficulties and intake success rate using videos collected in this study. The specific aims are: Develop, evaluate, and refine OPTIMAL intervention protocol and training materials. The investigators will integrate evidence from literature and prior work to develop the intervention protocol and training materials, addressing resident mealtime difficulties, targeted PCMC strategies, and establishment of individualized PCMC plans. Separate focus group interviews of staff and family participants on the acceptability and appropriateness of the intervention protocol and training materials will be conducted before pilot testing. Data obtained will be used to refine the intervention protocol and training materials before pilot testing. Determine feasibility, fidelity, and usefulness of OPTIMAL. Feasibility on participant identification, recruitment, consent, and retention will be evaluated descriptively. Fidelity will be assessed on a) delivery of treatment (staff attendance to training sessions), b) receipt of treatment (staff knowledge and self-efficacy pre- & post-training), and c) enactment of treatment skills (staff PCMC&TCMC behaviors, quality of staff engagement). Focus group interviews of staff to assess the usefulness of OPTIMAL will be conducted after T3. Describe resident outcomes (Exploratory). The investigators will measure and describe resident mealtime difficulties, eating performance, intake success rate, body weight, and body mass index using descriptive statistics overtime for two treatment groups. Data obtained will inform estimates of effect sizes for a future larger-scale trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease and Related Dementias
Keywords
Alzheimer's Disease and Related Dementias, Mealtime, Eating, Behavioral Symptoms, Food Intake, Function, Nutrition, Nursing Homes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm1
Arm Type
Experimental
Arm Description
OPTIMAL
Intervention Type
Behavioral
Intervention Name(s)
OPTIMAL
Intervention Description
A person-centered mealtime care intervention
Primary Outcome Measure Information:
Title
Acceptability of OPTIMAL
Description
One separate focus group interview of staff and families, respectively, in each NH will be conducted following an interview guide to prioritize the multiple mealtime difficulties identified from literature and to explore their perceptions of the acceptability and areas of refinement of the intervention protocol and training materials.
Time Frame
After recruitment of staff and families of resident participants, before T1 (baseline)
Title
Feasibility data on identification, recruitment, consent, and retention of staff, residents, and family participant
Description
19 questions will be asked to assess the feasibility data on identification, recruitment, consent, and retention.
Time Frame
From recruitment/consent throughout the study completion, up to 12-weeks post baseline
Title
Staff attendance to training sessions
Description
Delivery of training, tracking staff's attendance at the group or individual training sessions using a checklist
Time Frame
During each OPTIMAL training session (within 2 weeks post baseline)
Title
Changes of staff PCMC-related knowledge and self-efficacy between pre- and post-OPTIMAL training
Description
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
Time Frame
Right before and after OPTIMAL training session (within 2 weeks post baseline)
Title
Change from baseline staff use of PCMC-related strategies at 6 weeks and 12 weeks
Description
The validated Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme capturing both verbal and nonverbal behaviors that address staff person-centered and task-centered mealtime care strategies will be used to code video-recorded observations collected from the proposed study. Briefly, codes for verbal behaviors in CUED include 8 positive behaviors and 4 negative behaviors. Nonverbal behaviors include 7 negative behaviors and 13 positive behaviors in 3 categories: 1) modification of resident eating ability represented by 5 behaviors (e.g., "adjusting pace"), 2) modification of care approaches represented by 3 behaviors (e.g., "adjusting proximity"), and 3) modification of dining environment represented by 5 behaviors (e.g., "reducing clutter").
Time Frame
T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Title
Usefulness of OPTIMAL
Description
Staff perceived usefulness of the OPTIMAL intervention (OPTIMAL group) or OPTIMAL training session (education control group) will be assessed using semi-structured focus group interviews.
Time Frame
After T3 data collection time point (12-weeks post baseline)
Title
Change from baseline resident mealtime difficulties at 6 weeks and 12 weeks
Description
Videos will be coded using CUED that have codes for resident mealtime difficulties grouped in three categories: 1) chewing or swallowing difficulties represented by 4 nonverbal behaviors, 2) functional impairment represented by 5 nonverbal behaviors, and 3) resistive behaviors represented by 6 nonverbal behaviors.
Time Frame
T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Title
Change from baseline resident eating performance at 6 weeks and 12 weeks
Description
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.
Time Frame
T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Title
Change from baseline resident intake success rate at 6 weeks and 12 weeks
Description
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.
Time Frame
T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Secondary Outcome Measure Information:
Title
Quality of staff engagement
Description
Quality of staff engagement will be assessed by Mealtime Engagement Scale developed by the PI with evidence of reliability and validity.
Time Frame
T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Title
Resident body weight in killograms
Description
Bodyweight will be measured in the early morning before breakfast with each individual resident dressing casual indoor clothes without shoes using the same digital body scale throughout the study. The investigators will assess body weight twice in one early morning of each time point and calculate the average of the two assessments.
Time Frame
T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The investigators will recruit direct care staff (N=20), families of residents (N=20), and residents with dementia (N=20) from NH sites following the exclusion and inclusion criteria after attrition rates are considered. Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Iowa Vateran's Home
City
Marshalltown
State/Province
Iowa
ZIP/Postal Code
50158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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OPTIMAL in NH Residents With Dementia

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