Intelligent Personal Assistant for Managing Depression in Homebound Older Adults

Not Applicable

Completed

Conditions: Aging
Physical Dependence

Interventions: Behavioral: VIPA and companion booklet

Registration Number: NCT04900272

Lead Sponsor: Northwestern University

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VIPA device and companion booklet	VIPA and companion booklet	For Aim 2, we will recruit a total of 20-40 older adult homebound patients who are likely to be socially isolated, through the Geriatric and General Internal Medicine clinics at Northwestern (over 2,300 homebound older adults) to use the VIPA and accompanying instructional booklet focused on social-isolation. Either the study PI or Research Study Coordinator (RSC) will visit the participant's home, or assist the patient virtually, once consented, to set up the Google Home or Amazon Alexa device for them and review the companion VIPA booklet with them.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety	baseline, 4 weeks, 8 weeks, and 16 weeks	General Anxiety Disorder Scale (GAD-7): Total score (adding all the numbers) provides a possible score from 0-21, higher scores reflect more anxiety.
Change in Depression	baseline, 4 weeks, 8 weeks, and 16 weeks	Geriatric Depression Scale (GDS) - Short Form: scores range from 1 to 15, with higher scores reflecting more depressive symptoms.
Change in Social Isolation	baseline, 4 weeks, 8 weeks, and 16 weeks	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 represent T-scores, with a higher score representing higher levels of social isolation. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 55-60 represents mild social isolation, 60-70 represents moderate, and \>70 represents severe (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points).
Change in Companionship	baseline, 4 weeks, 8 weeks, and 16 weeks	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 represent T-scores, with higher scores representing higher levels of companionship. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 30-40 represents low companionship and \<30 represents very low (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points).
Change in Ability to Participate in Social Roles and Activities	baseline, 4 weeks, 8 weeks, and 16 weeks	PROMIS Ability to Participate in Social Roles and Activities -Short Form 4a: Scores represent T-scores, with higher scores representing a higher perceived ability to participate. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 40-45 represents mild difficulty in participating, 30-40 represents moderate, and \<30 represents severe (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points).
Change in Functional Status	baseline, 4 weeks, 8 weeks, and 16 weeks	PROMIS-Physical function 8b: PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. Scores represent T-scores, with higher scores representing higher levels of physical function. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 40-45 represents mild physical function concerns, 30-40 represents moderate, and \<30 represents severe (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points).
Change in Well-being	baseline, 4 weeks, 8 weeks, and 16 weeks	Neuro-QOL Positive Affect \& Well-Being: Scores represent T-scores, and higher scores indicate better self-reported well-being. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 30-40 represents low positive affect and \<30 represents very low (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points).
Change in Cognitive Function	baseline, 4 weeks, 8 weeks, and 16 weeks	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.
Change in Self Efficacy for Managing Social Interactions	baseline, 4 weeks, 8 weeks, and 16 weeks	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 represent T-scores, with higher scores representing higher self-efficacy. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 30-40 represents low self-efficacy and \<30 represents very low (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points).
Change in Acceptability	4 weeks, 8 weeks, and 16 weeks	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. Responses can range from 1 to 7, and scores represent an average of responses so can also range from 1 to 7, with higher scores representing greater acceptability.