Aging, Physical Dependence
Conditions
Keywords
Social Isolation, Loneliness, Older Adults, Homebound
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.
Interventions
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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 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 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 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 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
| Overall Study | Withdrawal due to technical difficulties (see above) | 3 |
Baseline characteristics
| Characteristic | VIPA Device and Companion Booklet |
|---|---|
| Age, Continuous | 80.53 years STANDARD_DEVIATION 8.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Change in Ability to Participate in Social Roles and Activities
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).
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Ability to Participate in Social Roles and Activities | Baseline | 52.97 T-score | Standard Deviation 6.72 |
| VIPA Device and Companion Booklet | Change in Ability to Participate in Social Roles and Activities | 4 weeks | 50.6 T-score | Standard Deviation 8.42 |
| VIPA Device and Companion Booklet | Change in Ability to Participate in Social Roles and Activities | 8 weeks | 50.39 T-score | Standard Deviation 8.23 |
| VIPA Device and Companion Booklet | Change in Ability to Participate in Social Roles and Activities | 16 weeks | 50.04 T-score | Standard Deviation 7.99 |
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. 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.
Time frame: 4 weeks, 8 weeks, and 16 weeks
Population: one participant had to miss each of the last two timepoints for logistical reasons
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Acceptability | 4 weeks | 5.2 score on a scale | Standard Deviation 1.36 |
| VIPA Device and Companion Booklet | Change in Acceptability | 8 weeks | 5.27 score on a scale | Standard Deviation 1.44 |
| VIPA Device and Companion Booklet | Change in Acceptability | 16 weeks | 5.34 score on a scale | Standard Deviation 1.53 |
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.
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Anxiety | Baseline | 5.44 score on a scale | Standard Deviation 5.85 |
| VIPA Device and Companion Booklet | Change in Anxiety | 4 weeks | 3.87 score on a scale | Standard Deviation 4 |
| VIPA Device and Companion Booklet | Change in Anxiety | 8 weeks | 5.57 score on a scale | Standard Deviation 4.82 |
| VIPA Device and Companion Booklet | Change in Anxiety | 16 weeks | 3.86 score on a scale | Standard Deviation 4.52 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Cognitive Function | Baseline | 15.71 score on a scale | Standard Deviation 4.31 |
| VIPA Device and Companion Booklet | Change in Cognitive Function | 4 weeks | 15 score on a scale | Standard Deviation 3.16 |
| VIPA Device and Companion Booklet | Change in Cognitive Function | 8 weeks | 16 score on a scale | Standard Deviation 4.69 |
| VIPA Device and Companion Booklet | Change in Cognitive Function | 16 weeks | 16 score on a scale | Standard Deviation 4.04 |
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 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).
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Companionship | Baseline | 48.26 T-score | Standard Deviation 7.27 |
| VIPA Device and Companion Booklet | Change in Companionship | 4 weeks | 45.06 T-score | Standard Deviation 9.03 |
| VIPA Device and Companion Booklet | Change in Companionship | 8 weeks | 48.72 T-score | Standard Deviation 7.99 |
| VIPA Device and Companion Booklet | Change in Companionship | 16 weeks | 46.36 T-score | Standard Deviation 10.35 |
Change in Depression
Geriatric Depression Scale (GDS) - Short Form: scores range from 1 to 15, with higher scores reflecting more depressive symptoms.
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Depression | Baseline | 3.31 score on a scale | Standard Deviation 2.65 |
| VIPA Device and Companion Booklet | Change in Depression | 4 weeks | 3.8 score on a scale | Standard Deviation 3.12 |
| VIPA Device and Companion Booklet | Change in Depression | 8 weeks | 2.54 score on a scale | Standard Deviation 1.71 |
| VIPA Device and Companion Booklet | Change in Depression | 16 weeks | 3.45 score on a scale | Standard Deviation 2.7 |
Change in Functional Status
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).
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Functional Status | Baseline | 33.46 T-score | Standard Deviation 7.82 |
| VIPA Device and Companion Booklet | Change in Functional Status | 4 weeks | 33.18 T-score | Standard Deviation 6.82 |
| VIPA Device and Companion Booklet | Change in Functional Status | 8 weeks | 31.7 T-score | Standard Deviation 6.93 |
| VIPA Device and Companion Booklet | Change in Functional Status | 16 weeks | 31.4 T-score | Standard Deviation 7.99 |
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 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).
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Self Efficacy for Managing Social Interactions | Baseline | 47.59 T-score | Standard Deviation 8.05 |
| VIPA Device and Companion Booklet | Change in Self Efficacy for Managing Social Interactions | 4 weeks | 48.54 T-score | Standard Deviation 9.19 |
| VIPA Device and Companion Booklet | Change in Self Efficacy for Managing Social Interactions | 8 weeks | 49.4 T-score | Standard Deviation 9.18 |
| VIPA Device and Companion Booklet | Change in Self Efficacy for Managing Social Interactions | 16 weeks | 45.96 T-score | Standard Deviation 8.15 |
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 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).
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Social Isolation | 16 weeks | 47.75 T-score | Standard Deviation 10.93 |
| VIPA Device and Companion Booklet | Change in Social Isolation | Baseline | 48.04 T-score | Standard Deviation 8.54 |
| VIPA Device and Companion Booklet | Change in Social Isolation | 4 weeks | 49.44 T-score | Standard Deviation 8.17 |
| VIPA Device and Companion Booklet | Change in Social Isolation | 8 weeks | 47.44 T-score | Standard Deviation 9.4 |
Change in Well-being
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).
Time frame: baseline, 4 weeks, 8 weeks, and 16 weeks
Population: one participant withdrew after baseline, and one participant missed each of the final two timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPA Device and Companion Booklet | Change in Well-being | Baseline | 54.27 T-score | Standard Deviation 7.25 |
| VIPA Device and Companion Booklet | Change in Well-being | 4 weeks | 54.73 T-score | Standard Deviation 7.08 |
| VIPA Device and Companion Booklet | Change in Well-being | 8 weeks | 55.21 T-score | Standard Deviation 9.32 |
| VIPA Device and Companion Booklet | Change in Well-being | 16 weeks | 54.66 T-score | Standard Deviation 9 |