Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04900272
Other study ID # STU00212384
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date July 15, 2022

Study information

Verified date May 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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. 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
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). baseline, 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, 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 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). baseline, 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 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
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). baseline, 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, 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 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
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, 4 weeks, 8 weeks, and 16 weeks
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). baseline, 4 weeks, 8 weeks, and 16 weeks
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A