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DementiaNCT04064164

Speeko for Elderspeak: A Self-Monitoring App to Improve Nursing Home Communication

A study testing Speeko for Elderspeak in people with Dementia and Staff Attitude, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Dementia, Staff Attitude
What is being tested?
Speeko for Elderspeak
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
9 Dec 2021to 30 Apr 2023
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 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • CNAs who are age 18 or older
  • Permanent employees
  • Fluent in English

Who cannot join

  • CNAs younger than 18 or
  • CNAs who are not fluent in English.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kansas School of Nursing

    Kansas City, Kansas, 66160

Other trials in United States

About this study

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

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).

Read the 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:

  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.
Being tested
Speeko for Elderspeak
Keywords
Nursing home, Dementia, Technology
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Speeko for ElderspeakBehavioural

    Speeko for Elderspeak is a communication feedback IOS application.

Study groups in NCT04064164
Study groupRoleWhat they receive
TreatmentExperimentalThe treatment NHs will received immediate feedback from the Speeko App after each recording sessions
Receives: Behavioral: Speeko for Elderspeak
ControlNo interventionThe Control NHs will not receive app feedback until all recording sessions are complete.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Elderspeak Measured by Diminutives Detected in Participant's Recorded Speech.

    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).

    Measured: Time1(baseline), Time 2 (immediately post-1 week CHATO training), Time 3 (2 weeks post-CHATO), Time 4 (4 weeks post-CHATO)

Secondary outcomes (2)
  1. 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. A single value was calculated by summing all scores across and averaged.

    Measured: 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).

  2. 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.

    Measured: The survey was completed by each nursing home at the end of the 3-month implementation period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2019
  2. Study start9 Dec 2021
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

Resources

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
Randomised
Intervention model
Parallel groups
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)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04064164
Sponsor's protocol ID
R21AG065029
Other IDs
R21AG065029
Status last verified
Dec 2024
First submitted
16 Aug 2019
Last updated
10 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Share study information vis Open Science Framework, platform created by Center for Open Science

Questions about this trial

What is this clinical trial studying?

A study testing Speeko for Elderspeak in people with Dementia and Staff Attitude, run by University of Kansas Medical Center 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 3 inclusion and 2 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 10 Jan 2025. 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 10 Jan 2025). 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?

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)). 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 10 Jan 2025.

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