N/A
Completed N=111
OPTIMAL in NH Residents With Dementia
Source: ClinicalTrials.gov NCT05255068 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice — 94 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice |
94 | — |
| PRIMARY Number of Staff and Resident Participants Recruited and Retained for the Study |
94; 16 | — |
| PRIMARY The Number of Staff Participants Who Attended All Training Sessions |
94 | — |
| PRIMARY Staff Person-centered Care Knowledge and Self-efficacy |
94 | — |
| PRIMARY Number of Staff Participants Who Viewed the Intervention Was Useful |
94 | — |
| PRIMARY The Number of Mealtime Difficulty Behaviors Observed in Residents |
6.5; 2.5; 4.2 | — |
| PRIMARY Resident Level of Eating Performance |
31; 28.4; 27.4 | — |
| PRIMARY Resident Intake Success Rate |
94.3; 92.2; 91.1 | — |
| SECONDARY Quality of Staff Engagement |
24.2; 13.9; 16.3 | — |
| SECONDARY Resident Body Mass Index (BMI). |
30.9; 30.1; 30.1 | — |
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)
Data sourced from ClinicalTrials.gov (NCT05255068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.