Alzheimer's Disease and Related Dementias
Conditions
Keywords
Alzheimer's Disease and Related Dementias, Mealtime, Eating, Behavioral Symptoms, Food Intake, Function, Nutrition, Nursing Homes
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.
Interventions
BEHAVIORALOPTIMAL
A person-centered mealtime care intervention
Sponsors
National Institute on Aging (NIA)
University of Iowa
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resident Intake Success Rate | 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. |
| The Number of Mealtime Difficulty Behaviors Observed in Residents | 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. |
| Resident Level of Eating Performance | 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). |
| The Number of Staff Participants Who Attended All Training Sessions | 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. |
| Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice | 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. |
| Number of Staff and Resident Participants Recruited and Retained for the Study | 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. |
| Staff Person-centered Care Knowledge and Self-efficacy | 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. |
| Number of Staff Participants Who Viewed the Intervention Was Useful | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resident Body Mass Index (BMI). | 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. |
| Quality of Staff Engagement | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm1 OPTIMAL
OPTIMAL: A person-centered mealtime care intervention. | 111 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Arm1 |
|---|---|
| Age, Continuous Resident participants | 73.9 years STANDARD_DEVIATION 7.9 |
| Age, Continuous Staff Participants | 44.8 years STANDARD_DEVIATION 12.1 |
| Education Level Resident Participants don't know/refused | 10 Participants |
| Education Level Resident Participants some college/college graduate/post-college | 4 Participants |
| Education Level Resident Participants up to high school | 3 Participants |
| Education Level Staff Participants don't know/refused | 25 Participants |
| Education Level Staff Participants some college/college graduate/post-college | 37 Participants |
| Education Level Staff Participants up to high school | 32 Participants |
| Race/Ethnicity, Customized resident participants Non white | 2 Participants |
| Race/Ethnicity, Customized resident participants While | 15 Participants |
| Race/Ethnicity, Customized staff participants Non white | 12 Participants |
| Race/Ethnicity, Customized staff participants While | 82 Participants |
| Region of Enrollment United States | 111 Participants |
| Sex: Female, Male Resident participants Female | 2 Participants |
| Sex: Female, Male Resident participants Male | 15 Participants |
| Sex: Female, Male Staff participants Female | 86 Participants |
| Sex: Female, Male Staff participants Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 17 | 0 / 0 |
| other Total, other adverse events | 0 / 94 | 0 / 17 | 0 / 0 |
| serious Total, serious adverse events | 0 / 94 | 0 / 17 | 0 / 0 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff | Number of Staff and Resident Participants Recruited and Retained for the Study | 94 Participants |
| Residents | Number of Staff and Resident Participants Recruited and Retained for the Study | 16 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff | Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice | 94 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff | Number of Staff Participants Who Viewed the Intervention Was Useful | 94 Participants |
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.
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff | Resident Intake Success Rate | Baseline | 94.3 percentage of resident successful intake | Standard Deviation 7.3 |
| Staff | Resident Intake Success Rate | Week 6 | 92.2 percentage of resident successful intake | Standard Deviation 7.7 |
| Staff | Resident Intake Success Rate | Week 12 | 91.1 percentage of resident successful intake | Standard Deviation 9.7 |
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).
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff | Resident Level of Eating Performance | Baseline | 31 score on a scale | Standard Deviation 6 |
| Staff | Resident Level of Eating Performance | Week 6 | 28.4 score on a scale | Standard Deviation 8.4 |
| Staff | Resident Level of Eating Performance | week 12 | 27.4 score on a scale | Standard Deviation 8.8 |
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.
Time frame: Right before and after OPTIMAL training session (within 2 weeks post baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff | Staff Person-centered Care Knowledge and Self-efficacy | 94 Participants |
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.
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff | The Number of Mealtime Difficulty Behaviors Observed in Residents | Baseline | 6.5 number of mealtime difficulty behaviors | Standard Deviation 4.6 |
| Staff | The Number of Mealtime Difficulty Behaviors Observed in Residents | Week 6 | 2.5 number of mealtime difficulty behaviors | Standard Deviation 2.9 |
| Staff | The Number of Mealtime Difficulty Behaviors Observed in Residents | Week 12 | 4.2 number of mealtime difficulty behaviors | Standard Deviation 2.8 |
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.
Time frame: During each OPTIMAL training session (within 2 weeks post baseline)
Population: All 94 staff participants attended all the training sessions provided during the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff | The Number of Staff Participants Who Attended All Training Sessions | 94 Participants |
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).
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff | Quality of Staff Engagement | Baseline | 24.2 score on a scale | Standard Deviation 14.4 |
| Staff | Quality of Staff Engagement | Week 6 | 13.9 score on a scale | Standard Deviation 6.3 |
| Staff | Quality of Staff Engagement | Week 12 | 16.3 score on a scale | Standard Deviation 5.9 |
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.
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff | Resident Body Mass Index (BMI). | Baseline | 30.9 kg/m2 | Standard Deviation 5.1 |
| Staff | Resident Body Mass Index (BMI). | Week 6 | 30.1 kg/m2 | Standard Deviation 5.3 |
| Staff | Resident Body Mass Index (BMI). | Week 12 | 30.1 kg/m2 | Standard Deviation 5.9 |