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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG066856 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staff | Experimental | Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection. |
|
| Resident | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTIMAL | Behavioral | A person-centered mealtime care intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
| 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) |
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Liu Wen, PhD | The University Of Iowa College Of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa Vateran's Home | Marshalltown | Iowa | 50158 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Staff | Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm1 | OPTIMAL OPTIMAL: A person-centered mealtime care intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 111 participants (overall number) = 17 resident participants + 94 staff participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | After recruitment of staff participants and before T1 (baseline) |
|
Adverse event were collected at 3 time points: baseline (T1), immediately post intervention (6 weeks post baseline, T2), and 6-week post intervention (12 weeks post baseline, T3).
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is not different from the clinicaltrials.gov Definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Staff | Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wen Liu | The University of Iowa | 3193557104 | wen-liu-1@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2024 | Jan 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C105911 | Optimal Pressed Ceramic |
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Because this study is a single-group design, all participants were recruited from the nursing home site that was assigned as the intervention group. no one is blinded to the intervention assignment, but all participants and outcome assessors were blinded for the research questions/aims.
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| After T3 data collection time point (12-weeks post baseline) |
| 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) |
| 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) |
| 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) |
| 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) |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 111 participants (overall number) = 17 resident participants + 94 staff participants | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | 111 participants (overall number) = 17 resident participants + 94 staff participants | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education Level | 111 participants (overall number) = 17 resident participants + 94 staff participants | Count of Participants | Participants |
|
Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.
|
|
| 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. | These are the number of staff and resident participants that were recruited at baseline | Posted | Count of Participants | Participants | 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. | All 94 staff participants attended all the training sessions provided during the study | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | All 94 staff participants were interviewed on whether the intervention was useful post testing. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | number of mealtime difficulty behaviors | 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | percentage of resident successful intake | 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | kg/m2 | T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline) |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Families | In this study, we were initially planning to recruit families for our Aim 1 to collect feedback on the OPTIMAL intervention. The fact that we recruited 94 staff (initially planned for 20 staff recruitment), which is much more than we planned, and we were able to collect feedback from these staff on the OPTIMAL intervention which helped refinement of the intervention. Our team agreed that we received adequate feedback to move to Aim 2 and 3 (testing the OPTIMAL intervention in NH staff and residents, where families were not included in the proposed study). Therefore, we did not enroll families as participants, but communicated with them regarding the refined OPTIMAL and engaged N=5 family members in this effort where they served as community stakeholders and no individual characteristics were needed to be collected (rather than study participants/subjects who need to consent to be enrolled and followed up over time). | 0 | 0 | 0 | 0 | 0 | 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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