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临床试验/NCT05380180
NCT05380180已完成不适用

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

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2022年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
2
主要终点
Change in Social Isolation Measured by Friendship Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

OneClick Social Engagement Intervention Group

Experimental

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.

干预措施: OneClick Social Engagement Intervention (Other)

OneClick Social Engagement Waitlist Control Group

Other

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.

干预措施: OneClick Social Engagement Intervention Extension (Other)

结局指标

主要结局

Change in Social Isolation Measured by Friendship Scale

时间窗: 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)

Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale

时间窗: 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).

Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease

时间窗: 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).

Change in Social Isolation Measured by Friendship Scale

时间窗: Baseline, Week 4, Week 8

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

时间窗: Baseline, Week 4, Week 8

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

时间窗: Time Frame: Baseline, Week 4, 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).

次要结局

  • Change in Social Network Measured by Lubben Social Network Index(Baseline, Week 4, Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8)
  • Change in Social Activity Measured by Social Activity Frequency(Baseline, Week 4, and Week 8, Waitlist Group Extension Week 4, Waitlist Group Extension Week 8)
  • Change in Social Network Measured by Lubben Social Network Index(Baseline, Week 4, Week 8)
  • Change in Social Activity Measured by Social Activity Frequency(Baseline, Week 4, and Week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wendy Rogers

Khan Professor of Applied Health Sciences

University of Illinois at Urbana-Champaign

研究点 (2)

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