The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain

Not Applicable

Completed

Conditions: Loneliness
Pain, Chronic

Interventions: Behavioral: Conversational Voice Assistant-Enhanced
Behavioral: Conversational Voice Assistant-Standard

Registration Number: NCT05387447

Lead Sponsor: University of Nebraska

Brief Summary: Approximately 24% of community-dwelling older adults are socially isolated, and over 40% of adults 60 and older report feeling lonely. Over 50% of midlife and older adults who perceive their health as fair or poor are lonely in contrast to 27% percent who believe their health to be excellent or very good. Loneliness has been associated with high mortality and inflammation which can influence symptoms such as pain. Social isolation and pain further contribute to loneliness. Studies have reported one and a half greater odds of being socially isolated among older adults with clinical osteoarthritis (OA) of the hip and/or knee than someone with similar characteristics without OA. Pain is significant because it is highly prevalent among older adults and is associated with disability, social isolation, and greater costs and burden to health care systems. A recent review of the literature found that several interventions influence social isolation and loneliness. As these interventions require in-person interaction, those who are socially isolated or distanced due to pain may not benefit due to a lack of access. Current advancements in technology and social media may provide opportunities to reduce loneliness and pain due to social isolation. Online and technology-based interventions have shown potential to engage older adults to improve communication and social connection. Given that socialization with these approaches are supportive only when the other person is available for that interaction. An intervention that utilizes technology to incorporate solitary interventions may be efficacious. Studies found a trend for a positive relationship between the use of a voice assistant and loneliness in aging adults living alone.

Building upon this evidence on loneliness and pain research, conversational voice assistant (CVA) technology and personalized persuasion, investigators will conduct a 12-week randomized control pilot with older adults that live alone and self-report pain. Participants will interact with a standard or a personally enhanced loneliness routine delivered through a CVA. Investigators will explore intervention feasibility and examine the efficacy of both standard and personalized interventions on loneliness and secondary outcomes.

Detailed Description: Approximately 24% of community-dwelling older adults are socially isolated, and over 40% of adults 60 and older report feeling lonely. Over 50% of midlife and older adults who perceive their health as fair or poor are lonely in contrast to 27% percent who believe their health to be excellent or very good. Loneliness has been associated with high mortality and inflammation which can influence symptoms such as pain. Social isolation and pain further contribute to loneliness. Studies have reported one and a half greater odds of being socially isolated among older adults with clinical osteoarthritis (OA) of the hip and/or knee than someone with similar characteristics without OA. Pain is significant because it is highly prevalent among older adults and is associated with disability, social isolation, and greater costs and burden to health care systems. A recent review of the literature found that several interventions influence social isolation and loneliness. As these interventions require in-person interaction, those who are socially isolated or distanced due to pain may not benefit due to a lack of access. Current advancements in technology and social media may provide opportunities to reduce loneliness and pain due to social isolation. Online and technology-based interventions have shown potential to engage older adults to improve communication and social connection. Given that socialization with these approaches are supportive only when the other person is available for that interaction. An intervention that utilizes technology to incorporate solitary interventions may be efficacious. Studies found a trend for a positive relationship between the use of a voice assistant and loneliness in aging adults living alone.

Investigators propose to conduct a 12-week pilot trial with participants randomly assigned to either the conversational voice assistant-standard group (CVA-S) or the conversational voice assistant-enhanced loneliness routine treatment group (CVA-ELR). Data will be collected at pre- (baseline) and post-intervention (after 12-weeks). The 12-week duration was chosen based on published intervention studies designed to reduce loneliness in older adults. Both groups will receive basic training on how to use the conversational voice assistant.

The CVA-S group will receive an a priori set of evidence-based interactions to perform with the conversational voice assistant. The interaction will be 15 minutes, performed once in the morning and once in the evening, at preset times. The participants will do a meditation activity, play an interactive trivia game, and ask the assistant to tell a joke. These activities were selected based on prior literature. The CVA-ELR group will receive personalized intervention materials based on individual baseline personality and entertainment inventory results. Potential personalization tactics used to match intervention materials with each individual's personality and entertainment preferences include identification (name integration), expectation (customization claim), contextualization (meaningful personal context), descriptive (personal data), comparative (contrast to others), evaluative (personal recommendation). Both interventions will use the minimum viable user experience (UX) design approach to develop intervention materials and will be delivered through a smart speaker. Investigator developed questionnaires will be used to collect self-reported descriptive demographic and health history.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

Inclusion Criteria

≥ 60 years of age
Live alone (single-family home, independent, or assisted living)
Experienced or currently experiencing musculoskeletal pain
Wireless internet access via a broadband Internet connection

Exclusion Criteria

Memory loss as evidenced by poor performance on the Mini Cog (0 to 2 points)
Inability to speak English
Prior or current use of a conversational voice assistant
Unwilling to engage with the voice assistant

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conversational Voice Assistant-Enhanced	Conversational Voice Assistant-Enhanced	Participants will complete a personalized and tailored interactive routine with the voice assistant.
Conversational Voice Assistant-Standard	Conversational Voice Assistant-Standard	Participants will complete a standard interactive routine with the voice assistant.

Primary Outcome Measures

Name	Time	Method
Self-reported Pain Severity	Baseline and 12 weeks	Self-reported pain severity will be recorded using the Brief Pain Inventory Short Form. Scores range from 0 as minimal score meaning no pain or pain interference to 10 as maximum score that equates to severe pain or complete pain interference. Higher scores indicate worse symptoms.
Self-reported Loneliness	Baseline and 12 weeks	Self-reported loneliness will be recorded using the University of California Los Angeles Loneliness Scale. The range of scores is 20 minimum to 80 as the maximum. The cut-offs for loneliness severity: \<28 = no/low loneliness, 28 to 43 = moderate loneliness, and total score \>43 = high loneliness. Higher scores indicate worse self-reported loneliness. Scores will be compared between groups at baseline and 12-weeks post-intervention.

Secondary Outcome Measures

Name	Time	Method
Conversational Voice Assistant System Usability	12-weeks	Self-reported ease of use of the voice assistant routines will be recorded. Score range from a minimum of 0 and a maximum of 100. Higher scores mean better usability: 0-51 "awful" or "poor" usability (significant problems), 51-68 "okay" usability (room for improvement), 68-80.3 "good" usability, 80.3+ "excellent" usability (highly usable system). Scores will be compared between groups at 12-weeks post-intervention.
Geriatric Depression	Baseline and 12-weeks	Self-reported depressive symptoms will be recorded. Scores range from 0 as a minimum to a 15 as a maximum. Higher scores indicate worse depression: 0-4 normal, 5-8 5ild depression, 9-11 moderate depression, and 12-15: severe depression. Scores will be compared between groups at baseline and 12-weeks post-intervention.
Self-efficacy for Managing Symptoms	Baseline and 12-weeks	Self-reported self-efficacy or confidence in managing pain symptoms will be recorded using Patient-Reported Outcomes Measurement Information System (PROMIS). Scores range from a minimum of 0 to a maximum of 100. A score of 50 represents the average. Higher scores above 50 indicate better self-reported self-efficacy in managing pain. Scores will be compared between groups at baseline and 12-weeks post-intervention.

Trial Locations

Locations (4): Eastmont Senior Living Apartments
🇺🇸
Lincoln, Nebraska, United States
The Legacy
🇺🇸
Lincoln, Nebraska, United States
Trinity Courtyard
🇺🇸
Omaha, Nebraska, United States
Aksarben Village Senior Apartments
🇺🇸
Omaha, Nebraska, United States