- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05380180
Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology
October 10, 2023 updated by: Wendy Rogers, University of Illinois at Urbana-Champaign
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Champaign, Illinois, United States, 61821
- University of Illinois, Urbana Champaign
-
Chicago, Illinois, United States, 60645
- CJE Senior Living
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OneClick Social Engagement Intervention Group
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.
|
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.
|
Other: OneClick Social Engagement Waitlist Control Group
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Social Isolation Measured by Friendship Scale
Time Frame: Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
Measures six dimensions that contribute to social isolation.
Lower scores indicate lower extent of social isolation.
Range (0-24)
|
Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale
Time Frame: Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
Measures the respondents' subjective feeling of loneliness.
Higher scores indicate a greater feeling of loneliness.
Range (20-80).
|
Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease
Time Frame: Time Frame: Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
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: Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Social Network Measured by Lubben Social Network Index
Time Frame: Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
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).
|
Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
Change in Social Activity Measured by Social Activity Frequency
Time Frame: Baseline, Week 4, and Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
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).
|
Baseline, Week 4, and Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in System Usability Measured by System Usability Scale
Time Frame: Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
|
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).
|
Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
|
Change in Technology Acceptance Measured by Technology Acceptance Survey
Time Frame: Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
|
Measures technology acceptance including ease of use, usefulness, enjoyment, and intention to use a system.
Lower scores indicate lower acceptance.
Range (17-119).
|
Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
|
Change in Computer Proficiency Measure by Computer Proficiency Questionnaire (Short -Form)
Time Frame: Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
|
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).
|
Week 1 of intervention, Week 4 of intervention, Week 8 of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wendy A Rogers, Ph.D., University of Illinois at Urbana-Champaign
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Davis FD. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989;13(3):319-40.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2022
Primary Completion (Actual)
April 6, 2023
Study Completion (Actual)
June 6, 2023
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 12, 2022
First Posted (Actual)
May 18, 2022
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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