Speeko for Elderspeak
Primary Purpose
Dementia, Staff Attitude
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speeko for Elderspeak
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Nursing home, Dementia, Technology
Eligibility Criteria
Inclusion Criteria:
- CNAs who are age 18 or older
- Permanent employees
- Fluent in English
Exclusion Criteria:
- CNAs younger than 18 or
- CNAs who are not fluent in English.
Sites / Locations
- University of Kansas School of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
The treatment NHs will received immediate feedback from the Speeko App after each recording sessions
The Control NHs will not receive app feedback until all recording sessions are complete.
Outcomes
Primary Outcome Measures
Change in elderspeak measured by the number of diminutives detected in participant's recorded speech.
The number of diminutives detected by the Speeko for Elderspeak app will be correlated with manual psycholinguistic analysis to determine app accuracy. Diminutive data will be compared between the intervention and control groups and within nursing homes.
Secondary Outcome Measures
Acceptability as measured by System Usability Scale.
A validated, 10-item industry standard survey. Questions are in 5-point Likert scale with responses from strongly agree to strongly disagree. Question scores are converted to a 0-100 total score where lower scores indicate low usability and high scores indicate greater usability.
Evaluate the app cost by measuring wages per hour by NH role and costs associated with the Speeko for Elderspeak application.
The cost associated with elderspeak reduction will be calculated using primary outcomes, wage data, and application costs.
Full Information
NCT ID
NCT04064164
First Posted
August 16, 2019
Last Updated
May 9, 2023
Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04064164
Brief Title
Speeko for Elderspeak
Official Title
SPEEKO for Elderspeak: A Self-Monitoring App to Improve Communication and Reduce Behavioral Symptoms in Care for Persons With Alzheimer's Disease and Other Dementias
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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:
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.
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Staff Attitude
Keywords
Nursing home, Dementia, Technology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Six nursing homes will be randomly assigned to treatment and control conditions. All NHs will received the CHATO training. The treatment NHs will received immediate feedback from the Speeko App after each recording sessions whereas the Control NHs will not receive feedback until all recording sessions are complete.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
The treatment NHs will received immediate feedback from the Speeko App after each recording sessions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Control NHs will not receive app feedback until all recording sessions are complete.
Intervention Type
Behavioral
Intervention Name(s)
Speeko for Elderspeak
Intervention Description
Speeko for Elderspeak is a communication feedback IOS application.
Primary Outcome Measure Information:
Title
Change in elderspeak measured by the number of diminutives detected in participant's recorded speech.
Description
The number of diminutives detected by the Speeko for Elderspeak app will be correlated with manual psycholinguistic analysis to determine app accuracy. Diminutive data will be compared between the intervention and control groups and within nursing homes.
Time Frame
Four app recording sessions per nursing home, through study completion, 1 year.
Secondary Outcome Measure Information:
Title
Acceptability as measured by System Usability Scale.
Description
A validated, 10-item industry standard survey. Questions are in 5-point Likert scale with responses from strongly agree to strongly disagree. Question scores are converted to a 0-100 total score where lower scores indicate low usability and high scores indicate greater usability.
Time Frame
Survey completed after participants finish all recording sessions. At the end of the 3-month implementation period per nursing home
Title
Evaluate the app cost by measuring wages per hour by NH role and costs associated with the Speeko for Elderspeak application.
Description
The cost associated with elderspeak reduction will be calculated using primary outcomes, wage data, and application costs.
Time Frame
Survey completed by each nursing home after the CHATO training. By the end of the 3-month implementation period per nursing home
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
CNAs who are age 18 or older
Permanent employees
Fluent in English
Exclusion Criteria:
CNAs younger than 18 or
CNAs who are not fluent in English.
Facility Information:
Facility Name
University of Kansas School of Nursing
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Share study information vis Open Science Framework, platform created by Center for Open Science
IPD Sharing Time Frame
The data will be shared within one year of study completion.
IPD Sharing Access Criteria
https://cos.io/our-products/osf/
Learn more about this trial
Speeko for Elderspeak
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