Aging, Aging Well, Mild Cognitive Impairment
Conditions
Keywords
videoconferencing, social engagement, loneliness, social isolation, quality of life
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.
Interventions
OTHEROneClick 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.
OTHEROneClick 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.
Sponsors
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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
Intervention model description
Participants will be screened and assigned to either intervention group or wait-listed group.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Isolation Measured by Friendship Scale | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Network Measured by Lubben Social Network Index | Baseline, Week 4, 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). |
| Change in Social Activity Measured by Social Activity Frequency | Baseline, Week 4, and 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWendy A Rogers, Ph.D.
University of Illinois at Urbana-Champaign
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 50 |
| 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.
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. | 49 |
| Total | 99 |
Baseline characteristics
| Characteristic | OneClick Social Engagement Waitlist Control Group | Total | OneClick Social Engagement Intervention Group |
|---|---|---|---|
| Age, Continuous | 74.6 years STANDARD_DEVIATION 7.1 | 74.05 years STANDARD_DEVIATION 6.7 | 73.5 years STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 40 Participants | 86 Participants | 46 Participants |
| Region of Enrollment United States | 49 participants | 99 participants | 50 participants |
| Sex: Female, Male Female | 43 Participants | 81 Participants | 38 Participants |
| Sex: Female, Male Male | 6 Participants | 18 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 0 / 50 | 0 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
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).
Time frame: Baseline, Week 4, Week 8
Population: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale | Baseline | 37.93 score on a scale | Standard Deviation 8.94 |
| OneClick Social Engagement Intervention Group | Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale | Week 4 | 40.34 score on a scale | Standard Deviation 8.88 |
| OneClick Social Engagement Intervention Group | Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale | Week 8 | 38.05 score on a scale | Standard Deviation 8.92 |
| OneClick Social Engagement Waitlist Control Group | Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale | Baseline | 37.08 score on a scale | Standard Deviation 9.35 |
| OneClick Social Engagement Waitlist Control Group | Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale | Week 4 | 38.60 score on a scale | Standard Deviation 9.35 |
| OneClick Social Engagement Waitlist Control Group | Change in Loneliness Measured by University of California - Los Angeles (UCLA) Loneliness Scale | Week 8 | 39.00 score on a scale | Standard Deviation 9.62 |
Comparison: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.p-value: <0.05Mixed Models Analysis
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: Time Frame: Baseline, Week 4, Week 8
Population: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease | Baseline | 37.52 score on a scale | Standard Deviation 5.21 |
| OneClick Social Engagement Intervention Group | Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease | Week 4 | 36.88 score on a scale | Standard Deviation 5.56 |
| OneClick Social Engagement Intervention Group | Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease | Week 8 | 37.44 score on a scale | Standard Deviation 5.48 |
| OneClick Social Engagement Waitlist Control Group | Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease | Baseline | 37.81 score on a scale | Standard Deviation 5.11 |
| OneClick Social Engagement Waitlist Control Group | Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease | Week 4 | 36.63 score on a scale | Standard Deviation 5.52 |
| OneClick Social Engagement Waitlist Control Group | Change in Quality of Life Measured by Quality of Life in Alzheimer's Disease | Week 8 | 36.54 score on a scale | Standard Deviation 5.57 |
Comparison: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.p-value: <0.05Mixed Models Analysis
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)
Time frame: Baseline, Week 4, Week 8
Population: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in Social Isolation Measured by Friendship Scale | Baseline | 20.37 score on a scale | Standard Deviation 3.26 |
| OneClick Social Engagement Intervention Group | Change in Social Isolation Measured by Friendship Scale | Week 4 | 20.05 score on a scale | Standard Deviation 3.31 |
| OneClick Social Engagement Intervention Group | Change in Social Isolation Measured by Friendship Scale | Week 8 | 20.39 score on a scale | Standard Deviation 3.05 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Isolation Measured by Friendship Scale | Baseline | 20.54 score on a scale | Standard Deviation 3.3 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Isolation Measured by Friendship Scale | Week 4 | 20.23 score on a scale | Standard Deviation 3.35 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Isolation Measured by Friendship Scale | Week 8 | 19.54 score on a scale | Standard Deviation 4.34 |
Comparison: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.p-value: <0.05Mixed Models Analysis
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).
Time frame: Baseline, Week 4, and Week 8
Population: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in Social Activity Measured by Social Activity Frequency | Baseline | 26.84 score on a scale | Standard Deviation 4.01 |
| OneClick Social Engagement Intervention Group | Change in Social Activity Measured by Social Activity Frequency | Week 4 | 27.63 score on a scale | Standard Deviation 4.08 |
| OneClick Social Engagement Intervention Group | Change in Social Activity Measured by Social Activity Frequency | Week 8 | 28.07 score on a scale | Standard Deviation 4.69 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Activity Measured by Social Activity Frequency | Baseline | 27.98 score on a scale | Standard Deviation 3.98 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Activity Measured by Social Activity Frequency | Week 4 | 27.89 score on a scale | Standard Deviation 5.05 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Activity Measured by Social Activity Frequency | Week 8 | 27.30 score on a scale | Standard Deviation 4.44 |
Comparison: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.p-value: <0.05Mixed Models Analysis
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).
Time frame: Baseline, Week 4, Week 8
Population: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in Social Network Measured by Lubben Social Network Index | Baseline | 18.75 score on a scale | Standard Deviation 4.43 |
| OneClick Social Engagement Intervention Group | Change in Social Network Measured by Lubben Social Network Index | Week 4 | 17.59 score on a scale | Standard Deviation 5.5 |
| OneClick Social Engagement Intervention Group | Change in Social Network Measured by Lubben Social Network Index | Week 8 | 17.51 score on a scale | Standard Deviation 4.5 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Network Measured by Lubben Social Network Index | Baseline | 19.08 score on a scale | Standard Deviation 4.55 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Network Measured by Lubben Social Network Index | Week 4 | 17.28 score on a scale | Standard Deviation 4.9 |
| OneClick Social Engagement Waitlist Control Group | Change in Social Network Measured by Lubben Social Network Index | Week 8 | 17.54 score on a scale | Standard Deviation 4.74 |
Comparison: We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.p-value: <0.05Mixed Models Analysis
Other Pre-specified
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).
Time frame: Week 4 of intervention, Week 8 of intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in Computer Proficiency Measure by Computer Proficiency Questionnaire (Short -Form) | Change Score at Week 4 | 27.60 score on a scale | Standard Deviation 2.8 |
| OneClick Social Engagement Intervention Group | Change in Computer Proficiency Measure by Computer Proficiency Questionnaire (Short -Form) | Change Score at Week 8 | 28.10 score on a scale | Standard Deviation 2.6 |
Other Pre-specified
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).
Time frame: Week 4 of intervention, Week 8 of intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in System Usability Measured by System Usability Scale | Change Score at Week 4 | 63.80 Raw Score | Standard Deviation 18.7 |
| OneClick Social Engagement Intervention Group | Change in System Usability Measured by System Usability Scale | Change Score at Week 8 | 68.20 Raw Score | Standard Deviation 18.6 |
Other Pre-specified
Change in Technology Acceptance Measured by Technology Acceptance Survey
Measure of technology acceptance: perceived ease of use. Lower scores indicate lower perception of ease of use. Range (1-7).
Time frame: Week 4 of intervention, Week 8 of intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OneClick Social Engagement Intervention Group | Change in Technology Acceptance Measured by Technology Acceptance Survey | Change Score at Week 4 | 5.40 score on a scale | Standard Deviation 1.4 |
| OneClick Social Engagement Intervention Group | Change in Technology Acceptance Measured by Technology Acceptance Survey | Change Score at Week 8 | 5.70 score on a scale | Standard Deviation 1.2 |