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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06114485
Other study ID # STU#: 00211894
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2023
Est. completion date March 31, 2025

Study information

Verified date April 2024
Source Northwestern University
Contact Olga Barnas
Phone 312-503-4610
Email olga.barnas@northwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants will use Amazon Alexa to test a new voice-assisted program for mental health management. The older adult and their support person will use this program to help with goal setting, reminders, and various other services. Participants will be asked to complete surveys and assessments about their experiences during the 16-week study period. Participants will be randomized into two groups: those who receive a guide to help them with utilization of the program to its fullest potential and those who do not receive that guide.


Description:

Older adults have often been on the fringe of benefiting from technology. However, voice-controlled intelligent personal assistants (VIPAs; e.g. Google Home, Amazon Echo), with their natural interaction style and ease of use, are a simple interface technology that may be useful to older adults with depression and their caregivers in the home setting. Caregivers would be able to schedule and follow the interactions between the older adult and the VIPA. The VIPAs would potentially be able to provide functional, cognitive, and social stimulation as well as improve anti-depressant medication adherence through reminders to older adults. The aim is to evaluate a VIPA that was designed to provide the caregiver with the skills and tools to deliver stimulation and medication reminders to homebound older adults with depression. The program model is based on a simplified behavioral activation program designed for administration by lay persons. Through user centered design (UCD), the investigators have adapted the model for remote delivery by a caregiver with the aid of VIPAs that provide psychoeducation, as well as features that support social, cognitive, and functional stimulation and reminders. The ability to deliver a caregiver-coordinated depression management program remotely, through an easy-to-use voice activated end-user interface, has the potential to deliver cost-effective care, easily implementable, to millions of homebound older adults, who currently are unable to access effective treatment. The study duration will be 12 weeks. During those 12 weeks, participants will be able to use Amazon Echo Show 8 and the study's VIPA program to set goals, reminders, and the like to help with their mood. Participants will also be asked to completed associated assessments. Caregivers will be able to interact with a dashboard to see how their older adult participant is faring and also be asked to complete assessments.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date March 31, 2025
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adults 65 years or older - English-speaking - Elevated depressive symptoms (PHQ-9 = 10) - Have WiFi access - Cognitively intact (Montreal Cognitive Assessment (MOCA) score =24) - Homebound or difficulty leaving the home or Inclusion criteria: - Adults 18 years or older - English-speaking - Provide support to an older adult (65 or older) - Have access to Wi-Fi - Demonstrating capacity to consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
VIPA Treatment Program
Participants will receive and Alexa device with a behavioral activation program, along with a detailed guidebook about how to utilize the Alexa device and the VIPA program
Alexa with Guidebook
Participants will receive an Alexa device with a detailed guidebook on how to use the device.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive symptoms The Patient Health Questionnaire-9 (PHQ-9) PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity.
The PHQ-9 measures depressive symptom severity on a scale of 0-27, with higher scores indicating greater severity
16 weeks
Primary Anxiety symptoms The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater severity 16 weeks
Secondary Adherence The number of times the Alexa device was accessed (Usage; # communications with TES-VIPA) 8 weeks
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