Trial Outcomes & Findings for The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain (NCT NCT05387447)
NCT ID: NCT05387447
Last Updated: 2025-05-23
Results Overview
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.
COMPLETED
NA
58 participants
Baseline and 12 weeks
2025-05-23
Participant Flow
Participants enrolled from Aksarben Village Senior Apartments, Trinity Courtyard Senior Apartments, Eastmont Senior Living Apartments, The Legacy Senior Living apartments
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Participants changed their minds about study participation.
|
3
|
5
|
Baseline Characteristics
The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
Baseline characteristics by cohort
| Measure |
Conversational Voice Assistant-Standard
n=28 Participants
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.
|
Conversational Voice Assistant-Enhanced
n=30 Participants
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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Continuous
|
79.32 years
STANDARD_DEVIATION 7.83 • n=99 Participants
|
78.9 years
STANDARD_DEVIATION 7.76 • n=107 Participants
|
79 years
STANDARD_DEVIATION 7.85 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
30 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Self-reported Pain Severity
Pain Severity
|
3.42 units on a scale
n=99 Participants
|
3.76 units on a scale
n=107 Participants
|
3.6 units on a scale
n=206 Participants
|
|
Self-reported Pain Severity
Pain Interference
|
3.66 units on a scale
n=99 Participants
|
4.56 units on a scale
n=107 Participants
|
4.12 units on a scale
n=206 Participants
|
|
Self-Reported Loneliness
|
62.27 units on a scale
n=99 Participants
|
67.78 units on a scale
n=107 Participants
|
65.14 units on a scale
n=206 Participants
|
|
Geriatric Depression
|
6.92 units on a scale
n=99 Participants
|
7.79 units on a scale
n=107 Participants
|
7.10 units on a scale
n=206 Participants
|
|
Self-efficacy for Managing Symptoms
|
34 units on a scale
n=99 Participants
|
32 units on a scale
n=107 Participants
|
33 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Conversational Voice Assistant (Standard)
n=25 Participants
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.
|
Conversational Voice Assistant (Enhanced)
n=25 Participants
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.
|
|---|---|---|
|
Self-reported Pain Severity
Brief Pain Inventory Pain Interference
|
2.57 score on a scale
Standard Deviation 2.11
|
3.71 score on a scale
Standard Deviation 2.36
|
|
Self-reported Pain Severity
Brief Pain Inventory Pain Severity
|
3.22 score on a scale
Standard Deviation 2.21
|
3.89 score on a scale
Standard Deviation 2.69
|
PRIMARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Conversational Voice Assistant (Standard)
n=25 Participants
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.
|
Conversational Voice Assistant (Enhanced)
n=25 Participants
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.
|
|---|---|---|
|
Self-reported Loneliness
|
58.83 score on a scale
Standard Deviation 19.73
|
58.84 score on a scale
Standard Deviation 15.95
|
SECONDARY outcome
Timeframe: 12-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.
Outcome measures
| Measure |
Conversational Voice Assistant (Standard)
n=25 Participants
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.
|
Conversational Voice Assistant (Enhanced)
n=25 Participants
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.
|
|---|---|---|
|
Conversational Voice Assistant System Usability
|
66.29 score on a scale
Standard Deviation 6.94
|
74.5 score on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Conversational Voice Assistant (Standard)
n=25 Participants
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.
|
Conversational Voice Assistant (Enhanced)
n=25 Participants
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.
|
|---|---|---|
|
Geriatric Depression
|
6.25 score on a scale
Standard Deviation 2.36
|
6.65 score on a scale
Standard Deviation 2.54
|
SECONDARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Conversational Voice Assistant (Standard)
n=25 Participants
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.
|
Conversational Voice Assistant (Enhanced)
n=25 Participants
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.
|
|---|---|---|
|
Self-efficacy for Managing Symptoms
|
34 score on a scale
Standard Deviation 7.56
|
31 score on a scale
Standard Deviation 8.41
|
Adverse Events
Conversational Voice Assistant-Standard
Conversational Voice Assistant-Enhanced
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place