Iowa Vateran's Home
Marshalltown, Iowa, 50158, United States
NCT Number: NCT05255068
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Marshalltown, Iowa, 50158, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Staffs
Families
Exclusion criteria
Residents
A person-centered mealtime care intervention
Time frame: After recruitment of staff participants and before T1 (baseline)
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.
Time frame: From recruitment/consent throughout the study completion, up to 12-weeks post baseline
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.
Time frame: During each OPTIMAL training session (within 2 weeks post baseline)
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.
Time frame: Right before and after OPTIMAL training session (within 2 weeks post baseline)
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.
Time frame: After T3 data collection time point (12-weeks post baseline)
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.
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
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.
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
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).
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
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.
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
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).
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
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.
University of Iowa
Other
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)
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