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NCT05387447

The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain

Completed NA Results posted Last updated 23 May 2025
What this trial tests

NA trial testing Conversational Voice Assistant (Enhanced) in Pain, Chronic in 58 participants. Completed in 30 December 2023.

Timeline
1 March 2022
Primary endpoint
30 December 2023
30 December 2023

Quick facts

Lead sponsorUniversity of Nebraska
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment58
Start date1 March 2022
Primary completion30 December 2023
Estimated completion30 December 2023
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska

Who can join

60 and older, any sex, with Pain, Chronic or Loneliness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-reported Pain Severity Primary · 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.

Brief Pain Inventory Pain Interference
GroupValue95% CI
Conversational Voice Assistant (Standard)2.57± 2.11
Conversational Voice Assistant (Enhanced)3.71± 2.36
Brief Pain Inventory Pain Severity
GroupValue95% CI
Conversational Voice Assistant (Standard)3.22± 2.21
Conversational Voice Assistant (Enhanced)3.89± 2.69
Self-reported Loneliness Primary · 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.

GroupValue95% CI
Conversational Voice Assistant-Standard58.83± 19.73
Conversational Voice Assistant-Enhanced58.84± 15.95
Conversational Voice Assistant System Usability Secondary · 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.

GroupValue95% CI
Conversational Voice Assistant (Standard)66.29± 6.94
Conversational Voice Assistant (Enhanced)74.5± 11.9
Geriatric Depression Secondary · 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.

GroupValue95% CI
Conversational Voice Assistant-Standard6.25± 2.36
Conversational Voice Assistant-Enhanced6.65± 2.54
Self-efficacy for Managing Symptoms Secondary · 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.

GroupValue95% CI
Conversational Voice Assistant-Standard34± 7.56
Conversational Voice Assistant-Enhanced31± 8.41

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evaluating Older Adults' Engagement and Usability With AI-Driven Interventions: Randomized Pilot Study.
    Shade M, Yan C, Jones VK, Boron J. · · 2025 · cited 4× · PMID 39865552 · DOI 10.2196/64763

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Other recruiting trials for Pain, Chronic

Currently open trials in the same condition.

Other University of Nebraska trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05387447.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing