Aging Clinical Trial
Official title:
Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology
NCT number | NCT05380180 |
Other study ID # | 22212 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 15, 2022 |
Est. completion date | June 6, 2023 |
Verified date | October 2023 |
Source | University of Illinois at Urbana-Champaign |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | June 6, 2023 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois, Urbana Champaign | Champaign | Illinois |
United States | CJE Senior Living | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign |
United States,
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. — View 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. — View 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 — View Citation
Davis FD. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989;13(3):319-40.
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.
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.
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. — View 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):503-1 — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in System Usability Measured by System Usability Scale | 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 | |
Other | Change in Technology Acceptance Measured by Technology Acceptance Survey | 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 | |
Other | Change in Computer Proficiency Measure by Computer Proficiency Questionnaire (Short -Form) | 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 | |
Primary | 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) | Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8 | |
Primary | 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). | Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8 | |
Primary | 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). | Time Frame: Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8 | |
Secondary | 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). | Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8 | |
Secondary | 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). | Baseline, Week 4, and Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8 |
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