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The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain

The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05387447
Enrollment
58
Registered
2022-05-24
Start date
2022-03-01
Completion date
2023-12-30
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness, Pain, Chronic

Keywords

Older Adults, Pain, Loneliness, Voice Assistant Technology

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.

Interventions

BEHAVIORALConversational Voice Assistant (Enhanced)

Interactive routine is based on tailoring to the participants type of pain and personality.

BEHAVIORALConversational Voice Assistant (Standard)

Interactive routine is a basic interaction with the voice assistant.

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported Pain SeverityBaseline and 12 weeksSelf-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 LonelinessBaseline and 12 weeksSelf-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

MeasureTime frameDescription
Conversational Voice Assistant System Usability12-weeksSelf-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 DepressionBaseline and 12-weeksSelf-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 SymptomsBaseline and 12-weeksSelf-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.

Countries

United States

Participant flow

Recruitment details

Participants enrolled from Aksarben Village Senior Apartments, Trinity Courtyard Senior Apartments, Eastmont Senior Living Apartments, The Legacy Senior Living apartments

Participants by arm

ArmCount
Conversational Voice Assistant-Standard
Participants will complete a standard interactive routine with the voice assistant. Conversational Voice Assistant-Standard: Interactive routine is a basic interaction with the voice assistant.
28
Conversational Voice Assistant-Enhanced
Participants will complete a personalized and tailored interactive routine with the voice assistant. Conversational Voice Assistant-Enhanced: Interactive routine is based on tailoring to the participants type of pain and personality.
30
Total58

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyParticipants changed their minds about study participation.35

Baseline characteristics

CharacteristicTotalConversational Voice Assistant-StandardConversational Voice Assistant-Enhanced
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
58 Participants28 Participants30 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous79 years
STANDARD_DEVIATION 7.85
79.32 years
STANDARD_DEVIATION 7.83
78.9 years
STANDARD_DEVIATION 7.76
Geriatric Depression7.10 units on a scale6.92 units on a scale7.79 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
57 Participants28 Participants29 Participants
Region of Enrollment
United States
58 participants28 participants30 participants
Self-efficacy for Managing Symptoms33 units on a scale34 units on a scale32 units on a scale
Self-Reported Loneliness65.14 units on a scale62.27 units on a scale67.78 units on a scale
Self-reported Pain Severity
Pain Interference
4.12 units on a scale3.66 units on a scale4.56 units on a scale
Self-reported Pain Severity
Pain Severity
3.6 units on a scale3.42 units on a scale3.76 units on a scale
Sex: Female, Male
Female
51 Participants24 Participants27 Participants
Sex: Female, Male
Male
7 Participants4 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 25
other
Total, other adverse events
0 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

Primary

Self-reported Loneliness

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.

Time frame: Baseline and 12 weeks

ArmMeasureValue (MEAN)Dispersion
Conversational Voice Assistant (Standard)Self-reported Loneliness58.83 score on a scaleStandard Deviation 19.73
Conversational Voice Assistant (Enhanced)Self-reported Loneliness58.84 score on a scaleStandard Deviation 15.95
p-value: 0.05Z score
Primary

Self-reported Pain Severity

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.

Time frame: Baseline and 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Conversational Voice Assistant (Standard)Self-reported Pain SeverityBrief Pain Inventory Pain Interference2.57 score on a scaleStandard Deviation 2.11
Conversational Voice Assistant (Standard)Self-reported Pain SeverityBrief Pain Inventory Pain Severity3.22 score on a scaleStandard Deviation 2.21
Conversational Voice Assistant (Enhanced)Self-reported Pain SeverityBrief Pain Inventory Pain Interference3.71 score on a scaleStandard Deviation 2.36
Conversational Voice Assistant (Enhanced)Self-reported Pain SeverityBrief Pain Inventory Pain Severity3.89 score on a scaleStandard Deviation 2.69
p-value: 0.05Z score
Secondary

Conversational Voice Assistant System Usability

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.

Time frame: 12-weeks

ArmMeasureValue (MEAN)Dispersion
Conversational Voice Assistant (Standard)Conversational Voice Assistant System Usability66.29 score on a scaleStandard Deviation 6.94
Conversational Voice Assistant (Enhanced)Conversational Voice Assistant System Usability74.5 score on a scaleStandard Deviation 11.9
Secondary

Geriatric Depression

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.

Time frame: Baseline and 12-weeks

ArmMeasureValue (MEAN)Dispersion
Conversational Voice Assistant (Standard)Geriatric Depression6.25 score on a scaleStandard Deviation 2.36
Conversational Voice Assistant (Enhanced)Geriatric Depression6.65 score on a scaleStandard Deviation 2.54
p-value: 0.05Z score
Secondary

Self-efficacy for Managing Symptoms

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.

Time frame: Baseline and 12-weeks

ArmMeasureValue (MEAN)Dispersion
Conversational Voice Assistant (Standard)Self-efficacy for Managing Symptoms34 score on a scaleStandard Deviation 7.56
Conversational Voice Assistant (Enhanced)Self-efficacy for Managing Symptoms31 score on a scaleStandard Deviation 8.41
p-value: 0.05Z score

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026