Trial Outcomes & Findings for OPTIMAL in NH Residents With Dementia (NCT NCT05255068)

NCT ID: NCT05255068

Last Updated: 2024-03-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 111 participants
• Primary outcome timeframe: After recruitment of staff participants and before T1 (baseline)
• Results posted on: 2024-03-13

Participant Flow

Families were to be recruited for Aim 1 only to collect feedback on OPTIMAL. We recruited 94 staff, much more than we planned (20 staff) and were able to collect adequate feedback from 94 staff on OPTIMAL for refinement. Our team agreed to move to Aim 2 and 3 (testing OPTIMAL in NH staff and residents) and we did not enroll families as participants but engaged some families of resident participants as community stakeholders (vs. participants/subjects) in refining OPTIMAL.

A total of 111 participants (94 staff, 17 residents) were enrolled at baseline, 1 resident lost to follow up at data collection time point 2, resulting in a total of 110 participants who retained in follow up data collections.

Participant milestones

Measure	Staff Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Overall Study STARTED	94	17
Overall Study COMPLETED	94	16
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Staff Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

111 participants (overall number) = 17 resident participants + 94 staff participants

Baseline characteristics by cohort

Measure	Arm1 n=111 Participants OPTIMAL OPTIMAL: A person-centered mealtime care intervention.
Age, Continuous Resident participants	73.9 years STANDARD_DEVIATION 7.9 • n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Age, Continuous Staff Participants	44.8 years STANDARD_DEVIATION 12.1 • n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Sex: Female, Male Resident participants · Female	2 Participants n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Sex: Female, Male Resident participants · Male	15 Participants n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Sex: Female, Male Staff participants · Female	86 Participants n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Sex: Female, Male Staff participants · Male	8 Participants n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Race/Ethnicity, Customized resident participants · While	15 Participants n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Race/Ethnicity, Customized resident participants · Non white	2 Participants n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Race/Ethnicity, Customized staff participants · While	82 Participants n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Race/Ethnicity, Customized staff participants · Non white	12 Participants n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Region of Enrollment United States	111 Participants n=111 Participants
Education Level Resident Participants · up to high school	3 Participants n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Education Level Resident Participants · some college/college graduate/post-college	4 Participants n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Education Level Resident Participants · don't know/refused	10 Participants n=17 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Education Level Staff Participants · up to high school	32 Participants n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Education Level Staff Participants · some college/college graduate/post-college	37 Participants n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants
Education Level Staff Participants · don't know/refused	25 Participants n=94 Participants • 111 participants (overall number) = 17 resident participants + 94 staff participants

PRIMARY outcome

Timeframe: After recruitment of staff participants and before T1 (baseline)

Population: Only the staff arm/group was assessed for this outcome measure, because only staff participants received training materials and training sessions directly from research team. In addition, the "residents" arm/group consisted of people living with moderate-to-severe dementia and were not able to provide accurate and valid information regarding whether the intervention protocol and training materials were acceptable and appropriate for nursing home 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.

Outcome measures

Measure	Staff n=94 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice	94 Participants	—

PRIMARY outcome

Timeframe: From recruitment/consent throughout the study completion, up to 12-weeks post baseline

Population: These are the number of staff and resident participants that were recruited at 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.

Outcome measures

Measure	Staff n=94 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents n=17 Participants Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Number of Staff and Resident Participants Recruited and Retained for the Study	94 Participants	16 Participants

PRIMARY outcome

Timeframe: During each OPTIMAL training session (within 2 weeks post baseline)

Population: All 94 staff participants attended all the training sessions provided during the study

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.

Outcome measures

Measure	Staff n=94 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
The Number of Staff Participants Who Attended All Training Sessions	94 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Staff n=94 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Staff Person-centered Care Knowledge and Self-efficacy	94 Participants	—

PRIMARY outcome

Timeframe: After T3 data collection time point (12-weeks post baseline)

Population: All 94 staff participants were interviewed on whether the intervention was useful post testing.

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.

Outcome measures

Measure	Staff n=94 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Number of Staff Participants Who Viewed the Intervention Was Useful	94 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Staff n=16 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
The Number of Mealtime Difficulty Behaviors Observed in Residents Week 12	4.2 number of mealtime difficulty behaviors Standard Deviation 2.8	—
The Number of Mealtime Difficulty Behaviors Observed in Residents Baseline	6.5 number of mealtime difficulty behaviors Standard Deviation 4.6	—
The Number of Mealtime Difficulty Behaviors Observed in Residents Week 6	2.5 number of mealtime difficulty behaviors Standard Deviation 2.9	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Staff n=16 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Resident Level of Eating Performance Baseline	31 score on a scale Standard Deviation 6	—
Resident Level of Eating Performance Week 6	28.4 score on a scale Standard Deviation 8.4	—
Resident Level of Eating Performance week 12	27.4 score on a scale Standard Deviation 8.8	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Staff n=16 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Resident Intake Success Rate Baseline	94.3 percentage of resident successful intake Standard Deviation 7.3	—
Resident Intake Success Rate Week 6	92.2 percentage of resident successful intake Standard Deviation 7.7	—
Resident Intake Success Rate Week 12	91.1 percentage of resident successful intake Standard Deviation 9.7	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Staff n=94 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Quality of Staff Engagement Baseline	24.2 score on a scale Standard Deviation 14.4	—
Quality of Staff Engagement Week 6	13.9 score on a scale Standard Deviation 6.3	—
Quality of Staff Engagement Week 12	16.3 score on a scale Standard Deviation 5.9	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Staff n=16 Participants Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.	Residents Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.
Resident Body Mass Index (BMI). Baseline	30.9 kg/m2 Standard Deviation 5.1	—
Resident Body Mass Index (BMI). Week 6	30.1 kg/m2 Standard Deviation 5.3	—
Resident Body Mass Index (BMI). Week 12	30.1 kg/m2 Standard Deviation 5.9	—

Adverse Events

Staff

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Residents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Families

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wen Liu

The University of Iowa

Phone: 3193557104

Email: wen-liu-1@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place