Intelligent Personal Assistant for Managing Depression in Homebound Older Adults

Aging Clinical Trial

Official title:

Intelligent Personal Assistant for Managing Depression in Homebound Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04900272
• Other study ID #: STU00212384
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to design a companion booklet and pilot test it with a voice-controlled intelligent personal assistants (VIPA), like Google Home or Amazon Alexa, to provide homebound older adult patients with skills and tools to help manage social isolation.

Description:

The objective of this pilot study is to design a companion booklet and pilot test it with a voice-controlled intelligent personal assistant (VIPA), Google Home or Amazon Alexa, to provide patients with skills and tools to help manage their social isolation. The companion booklet is a document that will be created using feedback obtained from a panel of geriatric experts, highlighting features of the VIPA that may be most beneficial to socially-isolated older adults. It will be submitted to the IRB for approval once finalized. The specific aims of this project are to: Aim 1: Design a companion booklet to be used in conjunction with a VIPA (Google Home/Amazon Alexa) for improving social isolation and communication among homebound older adults, defined as someone who is unable to leave the home without assistance of a device or another person, due to a physical or cognitive condition. Aim 2: Assess the feasibility and implementation of the VIPA (Google Home/Amazon Alexa) and the companion booklet and its impact on clinical and functional outcomes for older adults with social isolation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 65 years or older;
• Homebound patients of the Northwestern Medicine Geriatrics Program;
• English-speaking; and
• Able to verbally consent

Exclusion Criteria:

• Condition that limits ability to consent, such as severe cognitive impairment or lack of English proficiency
• Less than 65 years of age

Related Conditions & MeSH terms

• Aging
• Depression
• Physical Dependence

Intervention

Behavioral:
• VIPA and companion booklet
Participants will be asked to use the VIPA and accompanying second iteration of the instructional booklet focused on social-isolation. These participants will be surveyed over the phone for 16 weeks (baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks) with outcomes measured at each time point.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	The Claude D. Pepper Older Americans Independence Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Acceptability	usability assessment that we adapted from this original source: Questionnaire for User Interface Satisfaction. Based on: Lund, A.M. (2001) Measuring Usability with the USE Questionnaire. STC Usability SIG Newsletter, 8:2; constructs assessed: usefulness, ease of use, ease of learning, satisfaction.	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Social Isolation	PROMIS Social Isolation -Short Form 8a: The PROMIS Social Isolation item bank assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others; scores range from 8 to 40, with a higher score representing higher levels of social isolation	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Anxiety	General Anxiety Disorder Scale (GAD-7): Total score (adding all the numbers) provides a possible score from 0-21, higher scores reflect more anxiety.	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Self Efficacy for Managing Social Interactions	PROMIS Self Efficacy for Managing Social Interactions -Short Form 4a: : Confidence in participating in social activities and getting help when necessary. Managing communication with others about their medical condition, including communication with health professionals. Scores range from 4 to 20, with 20 representing higher self-efficacy	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Companionship	PROMIS Companionship -Short Form 4a: The PROMIS adult Companionship item bank assesses perceived availability of someone with whom to share enjoyable social activities such as visiting, talking, celebrations, etc. Scores range from 4 to 20, with higher scores representing higher levels of companionship.	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Ability to Participate in Social Roles and Activities	PROMIS Ability to Participate in Social Roles and Activities -Short Form 4a: scores range from 4 to 20, with higher scores representing a higher perceived ability to participate	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Depression	Geriatric Depression Scale (GDS) - Short Form: scores range from 1 to 15, with higher scores reflecting more depressive symptoms.	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Functional Status	PROMIS-Physical function 8b: PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. Scores range from 8 to 40. A higher score represents higher levels of physical function.	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Cognitive Function	Brief Montreal Cognitive Assessment (MoCA): The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Scores range from 0 to 22, with higher scores representing higher cognitive function. A score of 18 or higher is considered "normal" cognition.	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks
Primary	Change in Well-being	Neuro-QOL Positive Affect & Well-Being: Scores range from 9 to 26, and higher scores indicate better self-reported well-being.	baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks