NCT05380180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

May 12, 2022

Results QC Date

July 24, 2024

Last Update Submit

January 14, 2026

Conditions

Keywords

videoconferencingsocial engagementlonelinesssocial isolationquality of life

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (2)

  • 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

Other Outcomes (3)

  • Change in System Usability Measured by System Usability Scale

    Week 4 of intervention, Week 8 of intervention

  • Change in Technology Acceptance Measured by Technology Acceptance Survey

    Week 4 of intervention, Week 8 of intervention

  • Change in Computer Proficiency Measure by Computer Proficiency Questionnaire (Short -Form)

    Week 4 of intervention, Week 8 of intervention

Study Arms (2)

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.

Other: OneClick Social Engagement Intervention

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.

Other: OneClick Social Engagement Intervention Extension

Interventions

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 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. 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.

OneClick Social Engagement Waitlist Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois, Urbana Champaign

Champaign, Illinois, 61821, United States

Location

CJE Senior Living

Chicago, Illinois, 60645, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionSocial Isolation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSocial BehaviorBehavior

Results Point of Contact

Title
Wendy Rogers
Organization
University of Illinois Urbana-Champaign

Study Officials

  • Wendy A Rogers, Ph.D.

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be screened and assigned to either intervention group or wait-listed group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Khan Professor of Applied Health Sciences

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 18, 2022

Study Start

April 15, 2022

Primary Completion

April 6, 2023

Study Completion

June 6, 2023

Last Updated

January 16, 2026

Results First Posted

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations