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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

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

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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-weeks

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.

Outcome measures

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-weeks

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.

Outcome measures

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-weeks

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Conversational Voice Assistant-Enhanced

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcia Shade

University of Nebraska Medical Center

Phone: 402-559-6641

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place