Pain, ChronicNCT05387447
The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
A study testing Conversational Voice Assistant (Enhanced) and Conversational Voice Assistant (Standard) in people with Pain, Chronic and Loneliness, run by University of Nebraska at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic, Loneliness
- What is being tested?
- Conversational Voice Assistant (Enhanced) and Conversational Voice Assistant (Standard)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Legacy
Lincoln, Nebraska, 68506
Eastmont Senior Living Apartments
Lincoln, Nebraska, 68510
Trinity Courtyard
Omaha, Nebraska, 68046
Aksarben Village Senior Apartments
Omaha, Nebraska, 68106
About this study
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.
Read the 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.
- Conditions
- Pain, Chronic, Loneliness
- Being tested
- Conversational Voice Assistant (Enhanced), Conversational Voice Assistant (Standard)
- Keywords
- Older Adults, Pain, Loneliness, Voice Assistant Technology
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational Voice Assistant (Enhanced)Behavioural
Interactive routine is based on tailoring to the participants type of pain and personality.
Conversational Voice Assistant (Standard)Behavioural
Interactive routine is a basic interaction with the voice assistant.
| Study group | Role | What they receive |
|---|---|---|
| Conversational Voice Assistant (Enhanced) | Experimental | Participants will complete a personalized and tailored interactive routine with the voice assistant. Receives: Behavioral: Conversational Voice Assistant (Standard) |
| Conversational Voice Assistant (Standard) | Experimental | Participants will complete a standard interactive routine with the voice assistant. Receives: Behavioral: Conversational Voice Assistant (Enhanced) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Secondary outcomes (3)
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.
Measured: 12-weeks
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.
Measured: Baseline and 12-weeks
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.
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Mar 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcia Y Shade, PhD, RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387447
- Sponsor's protocol ID
- 0177-21-EP
- Status last verified
- May 2025
- First submitted
- 12 May 2022
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shade M, Yan C, Jones VK, Boron J. Evaluating Older Adults' Engagement and Usability With AI-Driven Interventions: Randomized Pilot Study. JMIR Form Res. 2025 Jan 24;9:e64763. doi: 10.2196/64763.
PubMed 39865552
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
- ClinicalTrials.gov ID
- NCT05387447
- Acronym / sponsor ID
- 0177-21-EP
- Conditions
- Pain, Chronic, Loneliness
- Keywords
- Older Adults, Pain, Loneliness, Voice Assistant Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversational Voice Assistant (Enhanced) | Experimental | Behavioral: Conversational Voice Assistant (Standard)Participants will complete a personalized and tailored interactive routine with the voice assistant. |
| Conversational Voice Assistant (Standard) | Experimental | Behavioral: Conversational Voice Assistant (Enhanced)Participants will complete a standard interactive routine with the voice assistant. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversational Voice Assistant (Enhanced)Interactive routine is based on tailoring to the participants type of pain and personality. | Behavioural | Conversational Voice Assistant (Standard) |
| Conversational Voice Assistant (Standard)Interactive routine is a basic interaction with the voice assistant. | Behavioural | Conversational Voice Assistant (Enhanced) |
Primary outcome
Self-reported Pain Severity
Time frame: 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
Time frame: 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.
3 secondary outcomes
Conversational Voice Assistant System Usability
Time frame: 12-weeks
Geriatric Depression
Time frame: Baseline and 12-weeks
Self-efficacy for Managing Symptoms
Time frame: Baseline and 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39865552Shade M, Yan C, Jones VK, Boron J. Evaluating Older Adults' Engagement and Usability With AI-Driven Interventions: Randomized Pilot Study. JMIR Form Res. 2025 Jan 24;9:e64763. doi: 10.2196/64763.
- Individual participant dataSharing planned: No
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Y Shade, PhD, RN principal investigator
University of Nebraska
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversational Voice Assistant (Enhanced) and Conversational Voice Assistant (Standard) in people with Pain, Chronic and Loneliness, run by University of Nebraska at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Pain Severity (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.