Trial Outcomes & Findings for Intelligent Personal Assistant for Managing Depression in Homebound Older Adults (NCT NCT04900272)

NCT ID: NCT04900272

Last Updated: 2024-06-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 4 weeks, 8 weeks, and 16 weeks
• Results posted on: 2024-06-20

Participant Flow

Participant milestones

Measure	VIPA Device 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. 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.
Overall Study STARTED	21
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	VIPA Device 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. 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.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal due to technical difficulties (see above)	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Intelligent Personal Assistant for Managing Depression in Homebound Older Adults

Baseline characteristics by cohort

Measure	VIPA Device and Companion Booklet n=17 Participants 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. 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.
Age, Continuous	80.53 years STANDARD_DEVIATION 8.12 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks, 8 weeks, and 16 weeks

Population: one participant had to miss each of the last two timepoints for logistical reasons

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.

Outcome measures

Measure	VIPA Device and Companion Booklet n=15 Participants 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. 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.
Change in Acceptability 4 weeks	5.2 score on a scale Standard Deviation 1.36
Change in Acceptability 8 weeks	5.27 score on a scale Standard Deviation 1.44
Change in Acceptability 16 weeks	5.34 score on a scale Standard Deviation 1.53

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

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).

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Social Isolation Baseline	48.04 T-score Standard Deviation 8.54
Change in Social Isolation 4 weeks	49.44 T-score Standard Deviation 8.17
Change in Social Isolation 8 weeks	47.44 T-score Standard Deviation 9.4
Change in Social Isolation 16 weeks	47.75 T-score Standard Deviation 10.93

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

General Anxiety Disorder Scale (GAD-7): Total score (adding all the numbers) provides a possible score from 0-21, higher scores reflect more anxiety.

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Anxiety Baseline	5.44 score on a scale Standard Deviation 5.85
Change in Anxiety 4 weeks	3.87 score on a scale Standard Deviation 4
Change in Anxiety 8 weeks	5.57 score on a scale Standard Deviation 4.82
Change in Anxiety 16 weeks	3.86 score on a scale Standard Deviation 4.52

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

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).

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Self Efficacy for Managing Social Interactions Baseline	47.59 T-score Standard Deviation 8.05
Change in Self Efficacy for Managing Social Interactions 4 weeks	48.54 T-score Standard Deviation 9.19
Change in Self Efficacy for Managing Social Interactions 8 weeks	49.4 T-score Standard Deviation 9.18
Change in Self Efficacy for Managing Social Interactions 16 weeks	45.96 T-score Standard Deviation 8.15

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

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).

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Companionship Baseline	48.26 T-score Standard Deviation 7.27
Change in Companionship 4 weeks	45.06 T-score Standard Deviation 9.03
Change in Companionship 8 weeks	48.72 T-score Standard Deviation 7.99
Change in Companionship 16 weeks	46.36 T-score Standard Deviation 10.35

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

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).

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Ability to Participate in Social Roles and Activities Baseline	52.97 T-score Standard Deviation 6.72
Change in Ability to Participate in Social Roles and Activities 4 weeks	50.6 T-score Standard Deviation 8.42
Change in Ability to Participate in Social Roles and Activities 8 weeks	50.39 T-score Standard Deviation 8.23
Change in Ability to Participate in Social Roles and Activities 16 weeks	50.04 T-score Standard Deviation 7.99

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

Geriatric Depression Scale (GDS) - Short Form: scores range from 1 to 15, with higher scores reflecting more depressive symptoms.

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Depression Baseline	3.31 score on a scale Standard Deviation 2.65
Change in Depression 4 weeks	3.8 score on a scale Standard Deviation 3.12
Change in Depression 8 weeks	2.54 score on a scale Standard Deviation 1.71
Change in Depression 16 weeks	3.45 score on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

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).

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Functional Status Baseline	33.46 T-score Standard Deviation 7.82
Change in Functional Status 4 weeks	33.18 T-score Standard Deviation 6.82
Change in Functional Status 8 weeks	31.7 T-score Standard Deviation 6.93
Change in Functional Status 16 weeks	31.4 T-score Standard Deviation 7.99

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: after baseline, 1 participant withdrew, and 1 participant missed each of the following timepoints. Only 7 participants completed this measure due to technical difficulties and hearing impairments that impeded participants' ability to complete this measure virtually.

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.

Outcome measures

Measure	VIPA Device and Companion Booklet n=7 Participants 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. 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.
Change in Cognitive Function Baseline	15.71 score on a scale Standard Deviation 4.31
Change in Cognitive Function 4 weeks	15 score on a scale Standard Deviation 3.16
Change in Cognitive Function 8 weeks	16 score on a scale Standard Deviation 4.69
Change in Cognitive Function 16 weeks	16 score on a scale Standard Deviation 4.04

PRIMARY outcome

Timeframe: baseline, 4 weeks, 8 weeks, and 16 weeks

Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints

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).

Outcome measures

Measure	VIPA Device and Companion Booklet n=16 Participants 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. 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.
Change in Well-being Baseline	54.27 T-score Standard Deviation 7.25
Change in Well-being 4 weeks	54.73 T-score Standard Deviation 7.08
Change in Well-being 8 weeks	55.21 T-score Standard Deviation 9.32
Change in Well-being 16 weeks	54.66 T-score Standard Deviation 9

Adverse Events

VIPA Device and Companion Booklet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine O'Brien

Northwestern University Feinberg School of Medicine

Phone: 314-747-5361

Email: obrien.k@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place