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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06239688
Other study ID # 23-1643
Secondary ID R01AG079124
Status Recruiting
Phase N/A
First received
Last updated
Start date April 12, 2024
Est. completion date February 28, 2027

Study information

Verified date May 2024
Source University of North Carolina, Chapel Hill
Contact Johanna Hickey, MSW
Phone 9198433085
Email jvtsilbersack@unc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project will compare two training models of an evidence-based online dementia care training program for direct care staff in assisted living to a waitlist control: 1) essentiALZ training and 2) essentiALZ training + Project ECHO. It will examine the extent to which each model is implemented and achieves its intended outcomes to improve staff knowledge and attitudes, change care practices, and improve the wellbeing of staff, residents, and residents' family members. Results will inform next steps in dementia care training for the assisted living (AL) and broader long-term care workforce. To examine these outcomes, data will be collected from AL staff and families over the course of 6 months. Staff will complete questionnaires and participate in interviews (as applicable) at baseline, post-training, 3-months, and 6-months. Families will participate in interviews at baseline, 3-months, and 6-months.


Description:

More than 75% of persons living with Alzheimer's disease and related dementias who reach 80 years of age require residential long-term care, which is increasingly provided in assisted living (AL). Across the country, almost 29,000 AL communities with more than 996,000 beds have become the primary residential care provider for persons with dementia: 90% of AL residents have cognitive impairment and 42% have recorded moderate or severe dementia, with actual rates being higher. AL provides supportive but not nursing services; consequently, virtually all care is provided by direct care workers (nursing assistants and personal care aides). Unfortunately, direct care workers are undervalued and under-trained, leading to poor care, workplace injury, dissatisfaction, and high turnover. AL is state-regulated, and only 17 states stipulate minimum training hours (some being as low as one hour), meaning that two-thirds of states are silent on training. Fewer than 40% of staff have education beyond high school, and so it is not surprising that a minority report sufficient knowledge to care for persons with dementia. In striving to fill this gap, training for direct care workers must be accessible and have efficacy in benefitting the staff, organization, and persons with dementia. Online training is an especially promising option due to its low cost, wide availability, and potential for self pacing, automated skills tests, and certification. The Alzheimer's Association is the national leader in dementia care training, and in 2021 developed essentiALZ (pronounced "essentials"), an online program teaching evidence-based, person-centered care, which can be accessed from a computer, tablet, or mobile device. Already more than 1,500 staff have essentiALZ certification, but as is true of the majority of training programs, evidence as to its ability to improve care and outcomes is lacking. It is possible that essentiALZ is effective in changing care and outcomes, but it may also be that additional supports are necessary to do so. A timely model of support is Project ECHO, which has flooded the field of long-term care as a proven way to provide expert guidance and peer support via a remote, online approach. Adding ECHO to online dementia training might provide a necessary boost to achieve care change and improved outcomes. The project responds to the National Institute on Aging Notice of Special Interest that calls for strengthening the workforce through enhancing and supporting skills training. It will conduct a hybrid implementation/effectiveness randomized trial in 126 AL communities, comparing essentiALZ alone, essentiALZ + ECHO enhancement, and a waitlist control. Outcomes grounded in the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model and the Kirkpatrick training effectiveness model will be examined over six months, comparing the arms in terms of (1) implementation and (2) effectiveness, and (3) examining the extent to which implementation and effectiveness differ based on characteristics of the AL community, staff, residents, and family members. Results will inform next steps in dementia care training for the AL and broader long-term care workforce.


Recruitment information / eligibility

Status Recruiting
Enrollment 1764
Est. completion date February 28, 2027
Est. primary completion date February 28, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: AL Staff: - Staff (part-time, full-time, and including contract staff) who provide direct care to residents at the participating assisted living community (e.g., certified nursing assistants, personal care aides, registered nurses, licensed practical nurses, activity directors, social workers, and others) as determined by the administrator/health care supervisor - Are 18 years of age or older - Are able to read and speak English fluently Family: - Resident not expected to die or be transferred in the next six months at baseline - At follow-up, resident lived in AL community at least one month during the three months prior to interview date - Are a family member/legally authorized representative (LAR), or designated contact of a resident with Alzheimer's disease and related dementia (ADRD) of a participating AL community - Are 18 years of age or older - Are English speaking - Visit the resident at least monthly Exclusion Criteria: AL Staff & Family: - Are under 18 years of age

Study Design


Intervention

Behavioral:
essentiALZ
essentiALZ is a web-based training that contains three hours of self-paced content separated into five modules, plus a final review. Modules include: 1) Alzheimer's disease and dementia; 2) person-centered care; 3) assessment and care planning; 4) activities of daily living; and 5) behaviors and communication. Staff will be encouraged to take the training over the course of four weeks.
Project ECHO
ECHO is a virtual tele-mentoring model grounded in case-based learning. It includes six weekly one-hour sessions of didactic and discussive learning. The first five sessions will reflect the content of the five essentiALZ modules, and the final session will address maintenance. ECHO sessions are group sessions that will be conducted via Zoom.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (3)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Alzheimer's Association, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

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* Note: There are 151 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Score Over Time of Sense of Competence in Dementia Care (SCIDS) Sense of Competence in Dementia Care (SCIDS) is a 17-item instrument. Responses are indicated using a 4-point Likert scale. Minimum score (worst value) = 1. Maximum score (best value) = 4. Higher values represent a better outcome (range 17-68). Measure is assessed at Baseline Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Primary Change in Score Over Time of Staff Experience of Working with Residents with Dementia Questionnaire - Care Organization, Satisfactory Contact with the Patient, and Satisfaction with the Expectations of Others Subscales (SEWDRQ) Staff Experience of Working with Residents with Dementia Questionnaire - Care Organization, Satisfactory Contact with the Patient, and Satisfaction with the Expectations of Others Subscales (SEWDRQ) is a 9-item instrument. Responses are indicated using a 5-point Likert scale. Minimum score (worst value) = 0. Maximum score (best value) = 4. Higher values represent a better outcome (range 0-36). Measure is assessed at Baseline Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Primary Change in Score Over Time of Dementia Attitude Scale - Short Form (DAS-6) Dementia Attitudes Scale (Short-Form) is a 6-item instrument. Responses are indicated using a 7-point Likert scale. Minimum score (worst value) = 1. Maximum score (best value) = 7. Higher values represent a better outcome (range 6-42). Measure is assessed at Baseline Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Secondary Change in Score Over Time of essentiALZ exam items essentiALZ exam items is a 5-item instrument. Instrument is a measure of knowledge on the subject of the intervention training. Responses are multiple choice, with only one answer per question considered 'correct'. Higher values of correct responses represent a better outcome/retention of knowledge (range 0-5). Measure is assessed at Baseline Questionnaire, Post-Training Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Secondary Change in Score Over Time of essentiALZ organizational practices essentiALZ exam items is a 5-item instrument. Instrument is a measure of knowledge on the subject of the intervention training. Responses are multiple choice, with only one answer per question considered 'correct'. Higher values of correct responses represent a better outcome/retention of knowledge (range 0-5). Measure is assessed at Baseline Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Secondary Change in Score Over Time of Emotional Burnout The researchers will assess intent to leave job by asking "Overall, based on your definition of burnout, how would you rate your level of burnout? Select one." Response options are: "1 = I enjoy my work. I have no symptoms of burnout.", "2 = Occasionally I am under stress, and I don't always have as much energy as I once did, but I don't feel burned out.", "3 - I am definitely burning out and have one or more symptoms of burnout, such as physical and emotional exhaustion.", "4 = The symptoms of burnout that I'm experiencing won't go away. I think about frustration at work a lot.", "5 = I feel completely burned out and often wonder if I can go on. I am at the point where I may need some changes or may need to seek some sort of help." Minimum = 1 (best value), maximum = 5 (worst value). Measure is assessed at Baseline Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Secondary Change in Score Over Time of Intention to Leave The researchers will assess intent to leave job by asking "How likely is it that you will leave this job in the next year? "Would you say... 1 is Not at All Likely, 2 is Somewhat Likely, 3 is Very Likely." Minimum = 1 (best value), maximum = 3 (worst value). Measure is assessed at Baseline Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
Secondary Change in Score Over Time of Feeling Valued essentiALZ exam items is a 5-item instrument. Instrument is a measure of knowledge on the subject of the intervention training. Responses are multiple choice, with only one answer per question considered 'correct'. Higher values of correct responses represent a better outcome/retention of knowledge (range 0-5). Measure is assessed at Baseline Questionnaire, a 3-month Follow Up Questionnaire and at a 6-month Follow Up Questionnaire. Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months
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