Clinical trial NCT05387447: The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
Official title: The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Loneliness
Keywords: Older Adults
Pain
Loneliness
Voice Assistant Technology
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported Pain Severity
timeFrame: Baseline and 12 weeks
measure: Self-reported Loneliness
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Conversational Voice Assistant System Usability
timeFrame: 12-weeks
measure: Geriatric Depression
timeFrame: Baseline and 12-weeks
measure: Self-efficacy for Managing Symptoms
timeFrame: Baseline and 12-weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: The Legacy
state: Nebraska
city: Lincoln
country: United States
facility: Eastmont Senior Living Apartments
state: Nebraska
city: Omaha
country: United States
facility: Trinity Courtyard
state: Nebraska
city: Omaha
country: United States
facility: Aksarben Village Senior Apartments
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Marcia Y Shade, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: