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| Name | Class |
|---|---|
| The Claude D. Pepper Older Americans Independence Centers | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIPA device and companion booklet | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPA and companion booklet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks, 8 weeks, and 16 weeks |
| 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). | baseline, 4 weeks, 8 weeks, and 16 weeks |
| 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, 4 weeks, 8 weeks, and 16 weeks |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine O'Brien | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
17 participants completed the baseline interview, including demographic information, and were included here. However, 2 of those participants were lost to follow up and did not complete the rest of the study. Only 15 participants completed all interviews.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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. | one participant had to miss each of the last two timepoints for logistical reasons | Posted | Mean | Standard Deviation | score on a scale | 4 weeks, 8 weeks, and 16 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine O'Brien | Northwestern University Feinberg School of Medicine | 314-747-5361 | obrien.k@wustl.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2021 | Oct 28, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2022 | Oct 28, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| baseline, 4 weeks, 8 weeks, and 16 weeks |
| 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). | baseline, 4 weeks, 8 weeks, and 16 weeks |
| 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). | baseline, 4 weeks, 8 weeks, and 16 weeks |
| Change in Depression | Geriatric Depression Scale (GDS) - Short Form: scores range from 1 to 15, with higher scores reflecting more depressive symptoms. | baseline, 4 weeks, 8 weeks, and 16 weeks |
| 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). | baseline, 4 weeks, 8 weeks, and 16 weeks |
| 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, 4 weeks, 8 weeks, and 16 weeks |
| 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). | baseline, 4 weeks, 8 weeks, and 16 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 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). | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | T-score | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| 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. | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| 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 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). | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | T-score | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| 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 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). | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | T-score | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| Primary | 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). | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | T-score | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| Primary | Change in Depression | Geriatric Depression Scale (GDS) - Short Form: scores range from 1 to 15, with higher scores reflecting more depressive symptoms. | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| 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 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). | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | T-score | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks, 8 weeks, and 16 weeks |
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| Primary | 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). | one participant withdrew after baseline, and one participant missed each of the final two timepoints | Posted | Mean | Standard Deviation | T-score | baseline, 4 weeks, 8 weeks, and 16 weeks |
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