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

Sponsor
University of Illinois at Urbana-Champaign (Other)
Overall Status
Recruiting
CT.gov ID
NCT05380180
Collaborator
(none)
120
2
2
16.5
60
3.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: OneClick Social Engagement Intervention
  • Other: OneClick Social Engagement Intervention Extension
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be screened and assigned to either intervention group or wait-listed group.Participants will be screened and assigned to either intervention group or wait-listed group.
Masking:
Single (Investigator)
Masking Description:
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
Primary Purpose:
Other
Official Title:
Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology
Anticipated Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

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.

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in Social Isolation Measured by Friendship Scale [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)

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

  3. Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease [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).

Secondary Outcome Measures

  1. 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]

    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).

  2. 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]

    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).

Other Outcome Measures

  1. Change in System Usability Measured by System Usability Scale [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).

  2. Change in Technology Acceptance Measured by Technology Acceptance Survey [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).

  3. Change in Computer Proficiency Measure by Computer Proficiency Questionnaire (Short -Form) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois, Urbana Champaign Champaign Illinois United States 61821
2 CJE Senior Living Chicago Illinois United States 60645

Sponsors and Collaborators

  • University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: Wendy A Rogers, Ph.D., University of Illinois at Urbana-Champaign

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wendy Rogers, Khan Professor of Applied Health Sciences, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT05380180
Other Study ID Numbers:
  • 22212
First Posted:
May 18, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wendy Rogers, Khan Professor of Applied Health Sciences, University of Illinois at Urbana-Champaign
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022