NCT04064164

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 10, 2025

Completed
Last Updated

January 10, 2025

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

August 16, 2019

Results QC Date

July 18, 2024

Last Update Submit

December 16, 2024

Conditions

DementiaStaff Attitude

Keywords

Nursing homeDementiaTechnology

Outcome Measures

Primary Outcomes (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).

    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)

  • Acceptability as Measured by System Usability Scale.

    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.

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

Study Arms (2)

Treatment

EXPERIMENTAL

The treatment NHs will received immediate feedback from the Speeko App after each recording sessions

Behavioral: Speeko for Elderspeak

Control

NO INTERVENTION

The Control NHs will not receive app feedback until all recording sessions are complete.

Interventions

Speeko for ElderspeakBEHAVIORAL

Speeko for Elderspeak is a communication feedback IOS application.

Treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas School of Nursing

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Kristine Williams
Organization
University of Kansas School of Nursing
kwilliams1@kumc.edu
7859797879

Study Officials

  • Kristine Williams, RN, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 21, 2019

Study Start

December 9, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

January 10, 2025

Results First Posted

January 10, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Share study information vis Open Science Framework, platform created by Center for Open Science

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The data will be shared within one year of study completion.
Access Criteria
https://cos.io/our-products/osf/

Locations

US(1)