Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05387447 |
| Other study ID # |
0177-21-EP |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
