OPTIMAL in NH Residents With Dementia

Alzheimer's Disease and Related Dementias Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05255068
• Other study ID #: K23AG066856
• Secondary ID: K23AG066856
• Status: Completed
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: November 5, 2022

Study information

• Verified date: February 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study developed and refined OPTIMAL, and evaluated its feasibility, fidelity, and usefulness. We used mixed methods (i.e., focus groups, a pilot single-group repeated measures) to refine and test OPTIMAL. We collected repeated measures 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, we assessed quality of staff engagement and resident outcomes including eating performance and BMI through collection and coding of videotaped observations of dyadic mealtime interaction (videos; Aim 2&3) over 6 meals in 2 consecutive days (2 breakfasts, 2 lunches, 2 dinners) for each staff-resident dyad. We used Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme, an innovative, feasible, and reliable tool that our team has developed and validated, and assessed resident mealtime challenging behaviors including resistive behaviors and functional impairments and intake success rate using videos collected in this study.11, 25

The specific aims are:

1. Develop, evaluate, and refine OPTIMAL intervention protocol and training materials. We will integrate evidence from literature and our prior work to develop the intervention protocol and training materials, addressing resident mealtime difficulties, targeted PCMC strategies, and establishment of individualized PCMC plans. We will conduct separate focus group interviews of staff and family participants on the acceptability and appropriateness of the intervention protocol and training materials before pilot testing. Data obtained will be used to refine the intervention protocol and training materials before pilot testing.

2. 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). We will conduct focus group interviews of staff to assess the usefulness of OPTIMAL after T3.

3. Describe resident outcomes (Exploratory). We will measure and describe resident mealtime difficulties, eating performance, intake success rate, body weight, and body mass index using descriptive statistics over time for two treatment groups. Data obtained will inform estimates of effect sizes for a future larger-scale trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 5, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The investigators will recruit direct care staff, families of residents, and residents with dementia 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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementias
• Dementia

Intervention

Behavioral:
• OPTIMAL
A person-centered mealtime care intervention

Locations

Country	Name	City	State
United States	Iowa Vateran's Home	Marshalltown	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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 (each item is scored on 0-3, total score range: 0-57, higher score = higher quality of engagement).	T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Secondary	Resident Body Mass Index (BMI).	Resident Body Mass Index (BMI, unit is kg/m2). We will assess body weight 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. We will assess body weight twice in one early morning of each time point and calculate the average of the two assessments for BMI.	T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)