Alzheimer's Disease and Related DementiasNCT05255068
OPTIMAL in NH Residents With Dementia
A study testing OPTIMAL in people with Alzheimer's Disease and Related Dementias, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease and Related Dementias
- What is being tested?
- OPTIMAL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 5 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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:
- 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.
- 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.
- 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.
- Being tested
- OPTIMAL
- Keywords
- Alzheimer's Disease and Related Dementias, Mealtime, Eating, Behavioral Symptoms, Food Intake, Function, Nutrition, Nursing Homes
- Medical subject headings
- Alzheimer Disease, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMALBehavioural
A person-centered mealtime care intervention
| Study group | Role | What they receive |
|---|---|---|
| Staff | Experimental | Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection. Receives: Behavioral: OPTIMAL |
| 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. Receives: Behavioral: OPTIMAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Secondary outcomes (2)
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).
Measured: 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.
Measured: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start16 May 2022
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's Disease and Related DementiasStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Wen Liu, University of Iowa
- Investigators
- Liu Wen, PhD, Principal investigator, The University Of Iowa College Of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255068
- Sponsor's protocol ID
- K23AG066856
- Other IDs
- K23AG066856
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2022
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05255068
- Acronym / sponsor ID
- K23AG066856
- Keywords
- Alzheimer's Disease and Related Dementias, Mealtime, Eating, Behavioral Symptoms, Food Intake, Function, Nutrition, Nursing Homes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staff | Experimental | Behavioral: OPTIMALStart participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection. |
| Resident | Experimental | Behavioral: OPTIMALResident 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMALA person-centered mealtime care intervention | Behavioural | Resident, Staff |
Primary outcome
Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice
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.
Number of Staff and Resident Participants Recruited and Retained for the Study
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.
The Number of Staff Participants Who Attended All Training Sessions
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.
Staff Person-centered Care Knowledge and Self-efficacy
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.
Number of Staff Participants Who Viewed the Intervention Was Useful
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.
The Number of Mealtime Difficulty Behaviors Observed in Residents
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.
Resident Level of Eating Performance
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).
Resident Intake Success Rate
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.
2 secondary outcomes
Quality of Staff Engagement
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Resident Body Mass Index (BMI).
Time frame: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Wen, PhD principal investigator
The University Of Iowa College Of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMAL in people with Alzheimer's Disease and Related Dementias, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice (time frame: After recruitment of staff participants and before T1 (baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.