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Speeko for Elderspeak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064164
Recruitment Status : Not yet recruiting
First Posted : August 21, 2019
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Kansas Medical Center

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).

Condition or disease Intervention/treatment Phase
Dementia Staff Attitude Behavioral: Speeko for Elderspeak Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Treatment
The treatment NHs will received immediate feedback from the Speeko App after each recording sessions
Behavioral: Speeko for Elderspeak
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.



Primary Outcome Measures :
  1. Change in elderspeak measured by the number of diminutives detected in participant's recorded speech. [ Time Frame: Four app recording sessions per nursing home, through study completion, 1 year. ]
    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 :
  1. Acceptability as measured by System Usability Scale. [ Time Frame: Survey completed after participants finish all recording sessions. At the end of the 3-month implementation period per nursing home ]
    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.

  2. Evaluate the app cost by measuring wages per hour by NH role and costs associated with the Speeko for Elderspeak application. [ Time Frame: Survey completed by each nursing home after the CHATO training. By the end of the 3-month implementation period per nursing home ]
    The cost associated with elderspeak reduction will be calculated using primary outcomes, wage data, and application costs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064164


Contacts
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Contact: Kristine N Williams, RN, PhD 9135881673 kwilliams1@kumc.edu
Contact: Carissa K Coleman, PhD 9702706839 ccoleman3@kumc.edu

Locations
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United States, Kansas
University of Kansas School of Nursing
Kansas City, Kansas, United States, 66160
Contact: Kristine Williams, PhD    913-588-1673    kwilliams1@kumc.edu   
Contact: Carissa Coleman, PhD    970-270-6839    ccoleman3@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Aging (NIA)
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04064164    
Other Study ID Numbers: STUDY00143911
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share study information vis Open Science Framework, platform created by Center for Open Science
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: The data will be shared within one year of study completion.
Access Criteria: https://cos.io/our-products/osf/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Nursing home
Dementia
Technology
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders