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Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology

Primary Purpose

Aging, Mild Cognitive Impairment, Aging Well

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OneClick Social Engagement Intervention
OneClick Social Engagement Intervention Extension
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aging focused on measuring videoconferencing, social engagement, loneliness, social isolation, quality of life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 65+
  • Fluent in English
  • Adequate visual and auditory acuity
  • Passing score on Telephone Interview for Cognitive Status - Modified (TICS-M) of 22 and above included
  • Passing score on Montreal Cognitive Assessment (MoCA) of 20 and above included
  • Geriatric Depression Scale (GDS) score of less than 9
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Access to and ability to use necessary resources for participating in technology-based intervention

Exclusion Criteria:

  • Diagnosis of dementia
  • Live in assisted living facility or skilled nursing facility

Sites / Locations

  • University of Illinois, Urbana Champaign
  • CJE Senior Living

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

OneClick Social Engagement Intervention Group

OneClick Social Engagement Waitlist Control Group

Arm Description

Intervention group participants will receive the social engagement OneClick intervention for 8 weeks, and will complete a mid-assessment at week 4, and a post-assessment at week 8.

Waitlist control group participants will receive no intervention for the first 8 weeks and will complete assessments at week 4 and week 8. Following the completion of the 8-week controlled portion, waitlist participants will be provided with the opportunity to participate in the OneClick social engagement intervention through the intervention extension.

Outcomes

Primary Outcome Measures

Change in Social Isolation Measured by Friendship Scale
Measures six dimensions that contribute to social isolation. Lower scores indicate lower extent of social isolation. Range (0-24)
Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale
Measures the respondents' subjective feeling of loneliness. Higher scores indicate a greater feeling of loneliness. Range (20-80).
Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease
Measures quality of life indicators such as physical health, energy, family, and money. Lower scores indicate a lower quality of life. Range (13-52).

Secondary Outcome Measures

Change in Social Network Measured by Lubben Social Network Index
Measures social network size for both family and friends and also the frequency of interaction with them. Higher scores indicate higher level of social engagement. Range (0-30).
Change in Social Activity Measured by Social Activity Frequency
Measures how often during the past year participants have engaged in various social activities. Lower scores indicate less engagement in social activities. Range (10-50).

Full Information

First Posted
May 12, 2022
Last Updated
October 10, 2023
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT05380180
Brief Title
Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology
Official Title
Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to rigorously assess the efficacy of an 8-week social engagement OneClick intervention. A total of 120 older adults with and without mild cognitive impairment (60 per group) will be randomized after a baseline assessment to the social engagement OneClick intervention group or the waitlist control group. Participants assigned to the intervention group will receive the social engagement OneClick intervention for 8 weeks, and will complete a mid-assessment at week 4, and a post-assessment at week 8. Participants assigned to the waitlist control group will receive no intervention for the first 8 weeks and will complete assessments at week 4 and week 8. Subsequently, as an extension to this study, participants assigned to the waitlist control group will have an opportunity to participate in 8 weeks of social engagement OneClick intervention, with intervention effects assessed at week 4 and week 8.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mild Cognitive Impairment, Aging Well
Keywords
videoconferencing, social engagement, loneliness, social isolation, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be screened and assigned to either intervention group or wait-listed group.
Masking
Investigator
Masking Description
All primary and secondary outcome assessments completed at Week 4 and Week 8 are blinded. Participants are told ahead of time to not share their group information with the blinded assessor during administration of measures. Supplementary outcome measures require the assessor to know the group assignment, as these measures pertain to their current experience in the intervention. Thus, all supplementary outcome measures are administered at a separate time by an unblinded assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OneClick Social Engagement Intervention Group
Arm Type
Experimental
Arm Description
Intervention group participants will receive the social engagement OneClick intervention for 8 weeks, and will complete a mid-assessment at week 4, and a post-assessment at week 8.
Arm Title
OneClick Social Engagement Waitlist Control Group
Arm Type
Other
Arm Description
Waitlist control group participants will receive no intervention for the first 8 weeks and will complete assessments at week 4 and week 8. Following the completion of the 8-week controlled portion, waitlist participants will be provided with the opportunity to participate in the OneClick social engagement intervention through the intervention extension.
Intervention Type
Other
Intervention Name(s)
OneClick Social Engagement Intervention
Intervention Description
Intervention group participants will receive the social engagement OneClick intervention for 8 weeks, and will complete a mid-assessment at week 4, and a post-assessment at week 8. Participants will use a computer or tablet to participate in two social engagement events per week. The intervention events will be delivered through the OneClick video conferencing platform. During each session participants will watch a short slideshow around a series of topics (e.g., nature, technology, hobbies) and get to engage in conversations surround the topics presented, which will be held in breakout rooms. Breakout room discussions will be set for 30 minutes, and participants will be provided with questions surrounding the topics to help stimulate conversation.
Intervention Type
Other
Intervention Name(s)
OneClick Social Engagement Intervention Extension
Intervention Description
Waitlist control group participants will receive no intervention for the first 8 weeks and will complete assessments at week 4 and week 8. Following the completion of the 8-week controlled portion, waitlist participants will be provided with the opportunity to participate in the OneClick social engagement intervention through the intervention extension. Waitlist participants will use a computer or tablet to participate in two social engagement events per week. The intervention events will be delivered through the OneClick video conferencing platform over the span of 8 weeks. Intervention effects will be measured at week 4 and week 8 of the intervention extension.
Primary Outcome Measure Information:
Title
Change in Social Isolation Measured by Friendship Scale
Description
Measures six dimensions that contribute to social isolation. Lower scores indicate lower extent of social isolation. Range (0-24)
Time Frame
Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
Title
Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale
Description
Measures the respondents' subjective feeling of loneliness. Higher scores indicate a greater feeling of loneliness. Range (20-80).
Time Frame
Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
Title
Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease
Description
Measures quality of life indicators such as physical health, energy, family, and money. Lower scores indicate a lower quality of life. Range (13-52).
Time Frame
Time Frame: Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
Secondary Outcome Measure Information:
Title
Change in Social Network Measured by Lubben Social Network Index
Description
Measures social network size for both family and friends and also the frequency of interaction with them. Higher scores indicate higher level of social engagement. Range (0-30).
Time Frame
Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
Title
Change in Social Activity Measured by Social Activity Frequency
Description
Measures how often during the past year participants have engaged in various social activities. Lower scores indicate less engagement in social activities. Range (10-50).
Time Frame
Baseline, Week 4, and Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
Other Pre-specified Outcome Measures:
Title
Change in System Usability Measured by System Usability Scale
Description
Measures the respondents' perception of usability of the OneClick system. Higher scores indicate higher ease of use and usefulness, and lower scores indicate more difficulty to use the system and decreased usefulness. Range (0-100).
Time Frame
Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
Title
Change in Technology Acceptance Measured by Technology Acceptance Survey
Description
Measures technology acceptance including ease of use, usefulness, enjoyment, and intention to use a system. Lower scores indicate lower acceptance. Range (17-119).
Time Frame
Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
Title
Change in Computer Proficiency Measure by Computer Proficiency Questionnaire (Short -Form)
Description
Measures the ability to perform a number of tasks using a computer. Tasks include computer basics, printing, communication, internet, scheduling, and multimedia. Higher scores indicated higher rates of proficiency. Range (6-30).
Time Frame
Week 1 of intervention, Week 4 of intervention, Week 8 of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 65+ Fluent in English Adequate visual and auditory acuity Passing score on Telephone Interview for Cognitive Status - Modified (TICS-M) of 22 and above included Passing score on Montreal Cognitive Assessment (MoCA) of 20 and above included Geriatric Depression Scale (GDS) score of less than 9 Stated willingness to comply with all study procedures and availability for the duration of the study Access to and ability to use necessary resources for participating in technology-based intervention Exclusion Criteria: Diagnosis of dementia Live in assisted living facility or skilled nursing facility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy A Rogers, Ph.D.
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois, Urbana Champaign
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61821
Country
United States
Facility Name
CJE Senior Living
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60645
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Hawthorne G. Measuring Social Isolation in Older Adults: Development and Initial Validation of the Friendship Scale. Soc Indic Res. 2006 Jul 1;77(3):521-48.
Results Reference
result
PubMed Identifier
8576833
Citation
Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
Results Reference
result
PubMed Identifier
12021425
Citation
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
Results Reference
result
PubMed Identifier
16921004
Citation
Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.
Results Reference
result
PubMed Identifier
31051042
Citation
Amano T, Morrow-Howell N, Park S. Patterns of Social Engagement Among Older Adults With Mild Cognitive Impairment. J Gerontol B Psychol Sci Soc Sci. 2020 Aug 13;75(7):1361-1371. doi: 10.1093/geronb/gbz051.
Results Reference
result
PubMed Identifier
22471867
Citation
Bennett DA, Schneider JA, Buchman AS, Barnes LL, Boyle PA, Wilson RS. Overview and findings from the rush Memory and Aging Project. Curr Alzheimer Res. 2012 Jul;9(6):646-63. doi: 10.2174/156720512801322663.
Results Reference
result
Citation
J. Brooke, "SUS-A Quick and Dirty Usability Scale," In P. W. Jordan, B. Thomas, B. A. Weerdmeester, A. L. McClelland, Eds., Usability Evaluation in Industry, Taylor and Francis, London, 1996.
Results Reference
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Citation
Davis FD. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989;13(3):319-40.
Results Reference
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Citation
Pikkarainen T, Pikkarainen K, Karjaluoto H, Pahnila S. Consumer acceptance of online banking: An extension of the Technology Acceptance Model. Internet Research. 2004 Jul 1;14:224-35.
Results Reference
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PubMed Identifier
24107443
Citation
Boot WR, Charness N, Czaja SJ, Sharit J, Rogers WA, Fisk AD, Mitzner T, Lee CC, Nair S. Computer proficiency questionnaire: assessing low and high computer proficient seniors. Gerontologist. 2015 Jun;55(3):404-11. doi: 10.1093/geront/gnt117. Epub 2013 Oct 9.
Results Reference
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Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology

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