Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04064164 |
| Other study ID # |
STUDY00143911 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 9, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of Kansas Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will test feasibility and preliminary effects of an automated and
performance-based feedback app (Speeko for Elderspeak) that detects and reports the use of
diminutives (terms of endearment such as honey, dearie, and sweetie), prevalent elderspeak
terms linked to BPSD. Building on proof of concept established in the laboratory, the app
will demonstrate feasibility at the point-of-care. Next, a clinical trial (N= 6NHs) will be
conducted to test preliminary efficacy of the app for amplifying reductions in diminutives
use for NH staff completing the CHATO training (3 online modules).
Description:
A new person is diagnosed with Alzheimer's disease or other dementia every 66 seconds, and
most persons with dementia (PWD) spend the late stages of dementia in nursing homes (NHs)
where lack of dementia care skills and staff shortages limit quality of care. Care of PWD in
NHs is complicated by behavioral and psychological symptoms of dementia (BPSD) such as
aggression, vocal outbursts, wandering, and withdrawal that occur as PWD lose cognitive and
communication abilities and cannot express their unmet physical and psychosocial needs. BPSD
present to NH staff as resistiveness to care (RTC) that increases staff stress and costly
time to complete care, often leading to staff turnover, injury, and inappropriate use of
psychotropic medications to control BPSD. Although Center for Medicare and Medicaid Services
(CMS) mandates and penalties have reduced antipsychotic medication use slightly,
contraindicated use in NH residents remains a pervasive problem, causing harmful side effects
and reducing the quality of life for PWD.
The PI and other researchers have empirically verified that RTC occurs when NH staff use
elderspeak (speech similar to baby talk) that features inappropriately intimate terms of
endearment (diminutives such as "honey"), belittling pronoun substitutions that imply
dependence ("the investigators" need a bath), and harsh task-oriented commands ("sit down").
Elderspeak conveys a message of disrespect and incompetence to residents who react with
withdrawal or BPSD. The R03 study established that residents with dementia are more than
twice as likely to exhibit BPSD (measured by coding RTC behavior in videos) when staff use
elderspeak instead of normal adult communication. The subsequent CHAT R01 trial verified that
staff reduced their use of elderspeak after attending the three-session Changing Talk (CHAT)
communication training program, and that this reduced RTC.
To facilitate dissemination, interactive online CHAT modules have been developed (CHATO)
which provides the same CHAT classroom content with the advantage of flexible access via the
internet for busy NH staff, including those in rural areas and small, independent NHs.
Recognizing the delay and incomplete adoption and application of evidence-based skills in
practice, the PI and colleagues believe additional strategies to optimize CHATO skills
implementation are indicated. Performance-based reinforcement of skills is effective in
achieving greater immediate implementation and long-term maintenance of new skills use in
practice. However, feasibility and costs for individualized expert feedback in NH settings
are usually prohibitive and thus not widely used in practice.
This study will test feasibility and preliminary effects of an automated and
performance-based feedback app that detects and reports the use of diminutives (terms of
endearment such as honey, dearie, and sweetie) which are prevalent elderspeak terms linked to
BPSD. The PI and colleagues developed the SPEEKO for Elderspeak app using archived NH
recordings from previous research to identify the most commonly used diminutives and then to
develop algorithms to detect them in speech. Building on proof of concept established in the
laboratory, the app will demonstrate feasibility at the point-of-care. Next, a clinical trial
(N= 6NHs) will be conducted to test preliminary efficacy of the app for amplifying reductions
in diminutives use for NH staff completing the CHATO training.
SPECIFIC AIMS:
1. AIM 1. Demonstrate feasibility, acceptability, and validity of the SPEEKO for Elderspeak
feedback app use by staff in the NH. Five certified nursing assistants (CNAs) will use
the app during NH care and provide feedback about any needed modifications. Hypothesis:
The app will be readily used and acceptable to CNAs. Diminutive counts determined by the
app will be correlated with psycholinguistic analysis, validating accuracy.
2. AIM 2. Test preliminary effects of an innovative self-monitoring feedback app on staff
elderspeak use and compare accuracy to psycholinguistic analyses of audio-recorded staff
communication. Hypothesis: Staff who receive immediate app feedback (N= 30 in three NHs)
will have greater elderspeak reduction after completing CHATO training compared to
delayed feedback controls (N= 30 in three NHs).
3. AIM 3. Evaluate app acceptability and costs. Hypothesis: Staff who use the app will find
it acceptable and beneficial for their practice. Process-based costing will be used to
determine costs for app use in NHs and other long-term service and support settings.
Costs will be compared in relation to each group's outcomes.
