The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
Primary Purpose
Pain, Chronic, Loneliness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conversational Voice Assistant-Enhanced
Conversational Voice Assistant-Standard
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Chronic focused on measuring Older Adults, Pain, Loneliness, Voice Assistant Technology
Eligibility Criteria
Inclusion Criteria:
- 1) men and women≥60 years of age; 2) live alone (single-family home, independent, or assisted living); 3) have experienced or currently experiencing musculoskeletal pain; and 4) wireless internet access via a broadband Internet connection.
Exclusion Criteria:
- 1) memory loss as evidenced by poor performance on the Mini Cog; 2) inability to speak English; 3) prior use or current use of a conversational voice assistant; and 4) not willing to engage with the voice assistant.
Sites / Locations
- The LegacyRecruiting
- Eastmont Senior Living ApartmentsRecruiting
- Trinity CourtyardRecruiting
- Aksarben Village Senior ApartmentsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conversational Voice Assistant-Standard
Conversational Voice Assistant-Enhanced
Arm Description
Participants will complete a standard interactive routine with the voice assistant.
Participants will complete a personalized and tailored interactive routine with the voice assistant.
Outcomes
Primary Outcome Measures
Brief Pain Inventory
Pain severity and Pain interference
University of California Los Angeles (UCLA) Loneliness Scale
Self-reported loneliness, The range of scores is 20 to 80. The cut-offs for loneliness severity: <28 = no/low loneliness, 28 to 43 = moderate loneliness, and total score >43 = high loneliness. Thus higher scores indicate worse (self-reported loneliness).
Secondary Outcome Measures
Usability
Self-reported ease of use of the voice assistant routines
Customer Satisfaction
Self-reported satisfaction with using the routine with the voice assistant
Depressive symptoms
self-reported depressive symptoms
Self-efficacy of managing pain
self-reported confidence in managing pain
Full Information
NCT ID
NCT05387447
First Posted
May 12, 2022
Last Updated
September 29, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT05387447
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Building upon existing evidence on loneliness and pain research, conversational voice assistant (CVA)technology and personalized persuasion, we have assembled an interdisciplinary and inter-institutional team of researchers to 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. We will explore intervention feasibility and examine the efficacy of both standard and personalized interventions on loneliness and secondary outcomes. Inclusion: 1) men and women 60 years of age; 2) live alone (single-family home, independent, or assisted living); 3) self-report have experienced or currently experiencing musculoskeletal pain; and 4) wireless internet access via a broadband Internet connection. Exclusion: 1) memory loss as evidenced by poor performance on the Mini Cog; 2) inability to speak English; 3) prior study participation; 4) prior use or current use of a conversational voice assistant; and 5) not willing to engage with the voice assistant. Our proposed study is comprised of 1) a one week pre-study session for participant equipment set-up, training, and baseline pre- study data collection; 2) a 12-week randomized trial of the standard or the enhanced CVA delivered interventions; and 3) a one-week post-study data collection.
Detailed Description
.We propose to conduct a 12-week pilot randomized controlled trial. Participants will be randomly assigned with equal distribution to the conversational voice assistant-standard group (CVA-S, n=30) or the conversational voice assistant-enhanced loneliness routine treatment group (CVA-ELR, n=30). 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.20 Both groups will receive basic training on how to use the conversational voice assistant.
Study Groups Group 1. Conversational Voice Assistant Standard Loneliness Routine (CVA-S) Participants in the CVA-S group will receive an a priori set of evidence-based interactions to perform with the conversational voice assistant. The interaction dose will be 15 minutes performed once in the morning and once in the evening, at pre-set times. The participants will 1) do a meditation activity, 2) play an interactive trivia game, and 3) ask the assistant to tell a joke. These activities were selected based on prior literature; programs involving meditation and humor therapy have been found to reduce loneliness, and humor therapy has also been found to relieve pain.25,26 Activities that encourage productive engagement have been found to help reduce social isolation and loneliness6, particularly those involving challenge.27 Group 2. Conversational Voice Assistant Enhanced Loneliness Routine (CVA-ELR) Participants in 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).28 The CVA-S and personalized CVA-ELR interventions will use the minimum viable user experience (UX) design approach to develop intervention materials and will be delivered through a smart speaker. 5,24,29 Participants: This study will include N=65 participants. Inclusion criteria include: 1) men and women≥60 years of age; 2) live alone (single-family home, independent, or assisted living); 3) have experienced or currently experiencing musculoskeletal pain; and 4) wireless internet access via a broadband Internet connection.
Exclusion criteria include: 1) memory loss as evidenced by poor performance on the Mini Cog; 2) inability to speak English; 3) prior use or current use of a conversational voice assistant; and 4) not willing to engage with the voice assistant.
Recruitment: We will use two main strategies for recruiting participants: 1) direct referral from those with ethical access in clinics and independent or assisted living facilities and 2) community and social media marketing.
Variables and Instruments Sample Characteristics Demographics, Health History and Social Support: Investigator developed questionnaires will be used to collect self-reported descriptive demographic and health history.
Aim 1. Examine the feasibility of using voice assistant technology to conduct a 12-week study with standard (CVA-S) and enhanced loneliness routine voice assistant (CVA-ELR) interactions among aging adults that live alone.
Outcomes Objective Use: We will securely access the participants' voice assistant profiles and document the time stamps of intervention activities to assess frequency and length of use, type of uses, and routine completion rates with the standard and enhanced loneliness routines.24 Usability: Usability will be measured using the System Usability Scale. The 10 question 5-point Likert scale scores range from 0-100 and scores above 68 are above average.30 Satisfaction: Short-term and long-term satisfaction will be measured with one question from the Customer Satisfaction (CST) and one question from the Net Promotor Score (NPS). The CST question "How would you rate the overall satisfaction with the program you received?" has a 1 to 5 scale response ranging from very unsatisfied to very satisfied. The NPS question "How likely is it that you would recommend the program to a friend or colleague?" has a scale from 1-10 with responses ranging very unlikely to very likely.31 A score of 7 or higher for CST or NPS indicates satisfaction of the intervention technology.32 A minimum coefficient alpha of .70 will be adopted for all usability outcome measures adhering to the minimum reliability standard in evaluation research.33 The minimum viable UX in both standard and enhanced conditions will produce satisfactory user comprehension of the intervention's key functionalities.
Aim 2. Evaluate the efficacy of standard (CVA-S) and enhanced loneliness routine voice assistant (CVA-ELR) interactions among aging adults that live alone.
Outcomes Loneliness: Subjective social isolation and loneliness will be measured using the University of California Los Angeles, UCLA Loneliness Scale Version 3, a 20-item instrument with responses of never, rarely, sometimes, and always. There is no standard accepted score for identifying loneliness; higher scores reflect greater reported loneliness. The scale has established validity and reliability with Cronbach's alphas ranging from 0.85 to 0.94.34 Pain Severity and Pain Interference: Subjective pain will be measured using the Brief Pain Inventory Short form (BPI-SF).The instrument has nine questions that measure pain severity and pain interference with function. The severity questions assess pain numerically ranging from 0 no pain to 10 pain as bad as you can imagine; interference questions assess interference from 0 no interference to 10 completely interferes. Higher scores indicate higher severity or interference with 0 being none, 1-3 mild, 4-6 moderate, 7-10 severe. The BPI-SF has Cronbach alphas ranging from 0.86-0.96.35 Data Analysis Aim #1: We will obtain descriptive statistics of the objective use data. We will use the mean score for each usability or satisfaction outcome to perform independent samples T-tests to compare the sample mean score with the critical cut off scores.
Aim #2: We will calculate mean and standard deviations on the UCLA Loneliness Scale and BPI-SF scores at baseline and after the 12-week intervention. We will compare the average questionnaire scores within and between the CVA-S and CVA-ELR groups using paired T-tests and multiple linear regression. The analysis will be run for the two outcomes separately. A minimum sample of 59 participants was calculated at 80% power, 0.35 effect size, and 0.05 significance. The proposed sample size accounts for a 10% study attrition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Loneliness
Keywords
Older Adults, Pain, Loneliness, Voice Assistant Technology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conversational Voice Assistant-Standard
Arm Type
Experimental
Arm Description
Participants will complete a standard interactive routine with the voice assistant.
Arm Title
Conversational Voice Assistant-Enhanced
Arm Type
Experimental
Arm Description
Participants will complete a personalized and tailored interactive routine with the voice assistant.
Intervention Type
Behavioral
Intervention Name(s)
Conversational Voice Assistant-Enhanced
Intervention Description
Interactive routine is based on tailoring to the participants type of pain and personality.
Intervention Type
Behavioral
Intervention Name(s)
Conversational Voice Assistant-Standard
Intervention Description
Interactive routine is a basic interaction with the voice assistant.
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
Pain severity and Pain interference
Time Frame
Change in pain severity and pain interference at 12 weeks
Title
University of California Los Angeles (UCLA) Loneliness Scale
Description
Self-reported loneliness, The range of scores is 20 to 80. The cut-offs for loneliness severity: <28 = no/low loneliness, 28 to 43 = moderate loneliness, and total score >43 = high loneliness. Thus higher scores indicate worse (self-reported loneliness).
Time Frame
Change in loneliness at 12 weeks
Secondary Outcome Measure Information:
Title
Usability
Description
Self-reported ease of use of the voice assistant routines
Time Frame
after 12 weeks
Title
Customer Satisfaction
Description
Self-reported satisfaction with using the routine with the voice assistant
Time Frame
after 12 weeks
Title
Depressive symptoms
Description
self-reported depressive symptoms
Time Frame
at day one and after 12-weeks
Title
Self-efficacy of managing pain
Description
self-reported confidence in managing pain
Time Frame
at day one and after 12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1) men and women≥60 years of age; 2) live alone (single-family home, independent, or assisted living); 3) have experienced or currently experiencing musculoskeletal pain; and 4) wireless internet access via a broadband Internet connection.
Exclusion Criteria:
1) memory loss as evidenced by poor performance on the Mini Cog; 2) inability to speak English; 3) prior use or current use of a conversational voice assistant; and 4) not willing to engage with the voice assistant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcia Y Shade, PhD, RN
Phone
402-559-6641
Email
marcia.shade@unmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor N Bacon
Email
taylor.bacon@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Y Shade, PhD, RN
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Legacy
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Y Shade, PhD, RN
Phone
402-559-6641
Email
marcia.shade@unmc.edu
Facility Name
Eastmont Senior Living Apartments
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Y Shade, PhD, RN
Phone
402-559-6641
Email
marcia.shade@unmc.edu
Facility Name
Trinity Courtyard
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Y Shade, PhD, RN
Phone
402-559-6641
Email
marcia.shade@unmc.edu
Facility Name
Aksarben Village Senior Apartments
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Y Shade, PhD, RN
Phone
402-559-6641
Email
marcia.shade@unmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
de-identified data if necessary
Learn more about this trial
The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
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