The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain

Pain, Chronic Clinical Trial

Official title:

The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387447
• Other study ID #: 0177-21-EP
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: Marcia Y Shade, PhD, RN
• Phone: 402-559-6641
• Email: marcia.shade[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Loneliness
• Pain, Chronic

Intervention

Behavioral:
• Conversational Voice Assistant-Enhanced
Interactive routine is based on tailoring to the participants type of pain and personality.
• Conversational Voice Assistant-Standard
Interactive routine is a basic interaction with the voice assistant.

Locations

Country	Name	City	State
United States	Eastmont Senior Living Apartments	Lincoln	Nebraska
United States	The Legacy	Lincoln	Nebraska
United States	Aksarben Village Senior Apartments	Omaha	Nebraska
United States	Trinity Courtyard	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory	Pain severity and Pain interference	Change in pain severity and pain interference at 12 weeks
Primary	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).	Change in loneliness at 12 weeks
Secondary	Usability	Self-reported ease of use of the voice assistant routines	after 12 weeks
Secondary	Customer Satisfaction	Self-reported satisfaction with using the routine with the voice assistant	after 12 weeks
Secondary	Depressive symptoms	self-reported depressive symptoms	at day one and after 12-weeks
Secondary	Self-efficacy of managing pain	self-reported confidence in managing pain	at day one and after 12-weeks