Clinical trial NCT05255068: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Keywords: Alzheimer's Disease and Related Dementias
Mealtime
Eating
Behavioral Symptoms
Food Intake
Function
Nutrition
Nursing Homes
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-02-24
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice
timeFrame: After recruitment of staff participants and before T1 (baseline)
measure: Number of Staff and Resident Participants Recruited and Retained for the Study
timeFrame: From recruitment/consent throughout the study completion, up to 12-weeks post baseline
measure: The Number of Staff Participants Who Attended All Training Sessions
timeFrame: During each OPTIMAL training session (within 2 weeks post baseline)
measure: Staff Person-centered Care Knowledge and Self-efficacy
timeFrame: Right before and after OPTIMAL training session (within 2 weeks post baseline)
measure: Number of Staff Participants Who Viewed the Intervention Was Useful
timeFrame: After T3 data collection time point (12-weeks post baseline)
measure: The Number of Mealtime Difficulty Behaviors Observed in Residents
timeFrame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
measure: Resident Level of Eating Performance
timeFrame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
measure: Resident Intake Success Rate
timeFrame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Secondary outcomes:
measure: Quality of Staff Engagement
timeFrame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
measure: Resident Body Mass Index (BMI).
timeFrame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Other outcomes:
Locations:
city: Marshalltown
country: United States
facility: Iowa Vateran's Home
state: Iowa
Study officials:
affiliation: The University Of Iowa College Of Nursing
name: Liu Wen, PhD
role: PRINCIPAL_INVESTIGATOR
References: