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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2023
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
OneClick Social Engagement Intervention
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.
OneClick Social Engagement 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.

Locations

Country Name City State
United States University of Illinois, Urbana Champaign Champaign Illinois
United States CJE Senior Living Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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.

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. — View Citation

Outcome

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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