- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04064164
Speeko for Elderspeak: A Self-Monitoring App to Improve Nursing Home Communication
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas School of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
The treatment NHs will received immediate feedback from the Speeko App after each recording sessions
|
Speeko for Elderspeak is a communication feedback IOS application.
|
|
No Intervention: Control
The Control NHs will not receive app feedback until all recording sessions are complete.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Elderspeak Measured by Diminutives Detected in Participant's Recorded Speech.
Time Frame: Time1(baseline), Time 2 (immediately post-1 week CHATO training), Time 3 (2 weeks post-CHATO), Time 4 (4 weeks post-CHATO)
|
Diminutive Use per Utterance detected by the Speeko for Elderspeak app.
Diminutive data will be compared between the intervention and control groups and within nursing homes.
The clinical trial could not be analyzed due to too few participants (COVID-19 Pandemic).
|
Time1(baseline), Time 2 (immediately post-1 week CHATO training), Time 3 (2 weeks post-CHATO), Time 4 (4 weeks post-CHATO)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability as Measured by System Usability Scale.
Time Frame: Survey completed after using the Speeko app during a feasibility session (pre-clinical trial) or at the end of all four recording sessions - Time 4 (4 weeks post-CHATO).
|
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.
A single value was calculated by summing all scores across and averaged.
|
Survey completed after using the Speeko app during a feasibility session (pre-clinical trial) or at the end of all four recording sessions - Time 4 (4 weeks post-CHATO).
|
|
Evaluate the App Cost by Measuring Wages Per Hour by NH Role and Costs Associated With the Speeko for Elderspeak Application.
Time Frame: The survey was completed by each nursing home at the end of the 3-month implementation period.
|
The cost associated with elderspeak reduction will be calculated using primary outcomes, wage data, and application costs.
|
The survey was completed by each nursing home at the end of the 3-month implementation period.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kristine Williams, RN, PhD, University of Kansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AG065029 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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