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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aging, Mild Cognitive Impairment, Aging Well

Intervention / Treatment
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* Other: OneClick Social Engagement Intervention
* Other: OneClick Social Engagement Intervention Extension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be screened and assigned to either intervention group or wait-listed group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OneClick Social Engagement Intervention Group<br>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. | Other: OneClick Social Engagement Intervention<br>* 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.<br>|
| Other: OneClick Social Engagement Waitlist Control Group<br>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. | Other: OneClick Social Engagement Intervention Extension<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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videoconferencing, social engagement, loneliness, social isolation, quality of life