Clinical trial NCT04480112: Impact of Covid-19 on Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults
Official title: Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Disorders
Alzheimer Disease
Mild Cognitive Impairment
Keywords: Social Isolation
Cognition
Misinformation
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will employ an AB/BA crossover design (2-sequence, 2-period, 2-treatment design) where A will be the intervention phase and B will be the passive control phase. Each period will have a duration of 1 month. Assessment of the primary outcome will be done at the end of each period. Since this is a study of a behavioral intervention, 4-week washout period will suffice to observe an acute change in cognitive performance without significant carryover effects.

To avoid imbalance among groups, randomization will be stratified by cognitive syndrome diagnosis (healthy older adult, mild cognitive impairment and mild dementia). Participants will be randomized to the treatment sequences using a 1:1 allocation ratio.
Primary purpose: OTHER

Brief summary: The current study will examine the impact of frequent social interaction through communication technologies during COVID-19 pandemic in the cognitive status of socially-isolated older adults with and without cognitive impairment. Patients will take place in an experimental crossover study, participants will complete one month of an intervention and one month of as passive control. The goal of this study is to determine: A.) if frequent social interaction through ICT during COVID-19 pandemic will have a significant positive impact in cognitive performance on testing, and B.) how social isolation and cognitive status influence misconceptions around the current pandemic.

Detailed description: The current study will examine the impact of frequent social interaction through communication technologies during COVID-19 pandemic in the cognitive status of socially-isolated older adults with and without cognitive impairment. An estimated 150 total participants will be recruited over the course of 1 year: 50 healthy older participants, 50 patients with amnestic mild cognitive impairment, and 50 patients with mild AD.

This study employs an AB/BA crossover design (2-sequence, 2-period, 2-treatment design) where A will be the intervention phase and B will be the passive control phase. Each period will occur over a duration of 1 month. Participants will either receive an intervention designed to provide participants with more social interaction during a time of social distancing and highly limited in-person social interactions (Intervention Group) or will not receive the intervention (Control Group). The investigators will conduct pre- and post- neuropsychological testing to assess changes in cognitive status (e.g., memory, language, executive functioning) in the intervention group after each intervention phase. Neuropsychological tests assessing changes to cognition will be completed prior to participant assignment to the Intervention or Control Group. Following this assessment, the first phase of the intervention will begin, and the initial intervention group (Group A) will receive the intervention, and the other group (Group B) will act as a control group. After the intervention phase has ended, both groups will be assessed again using neuropsychological tests. Following the re-assessment, Group B will receive the intervention, and Group A will act as a control. After the second intervention phase has ended, both groups will be assessed once more using neuropsychological tests.

Eligibility criteria: Inclusion Criteria:

* Recent diagnosis from the Boston University Alzheimer's Disease Center of mild AD (with a recent Mini Mental State Examination score greater than 20)
* Meet criteria for social isolation- a state in which an individual has a minimal number of social contacts and lacks engagement with others either physically or remotely through communication technology.
* English as their primary language
* Have access to either a computer, smart device, or telephone

Exclusion Criteria:

* Clinically significant depression
* Alcohol or drug use
* Cerebrovascular disease, traumatic brain damage, other degenerative disease (e.g., Parkinson's disease)
* Do not have corrected vision of 20/30 or better
* perform below 80% correct on the speech discrimination test from the Boston Diagnostic Aphasia Examination
* Score below 27 on the Mini-Mental State Examination (MMSE)
* Score below two standard deviations on any element of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Memory test

Primary outcomes:
measure: Change in memory performance
timeFrame: Baseline,1 month
measure: Change in cognition
timeFrame: Baseline, 1 month
measure: Change in phonemic fluency
timeFrame: Baseline, 1 month
Secondary outcomes:
measure: Social isolation
timeFrame: 1 month
measure: Loneliness
timeFrame: 1 month
measure: Depressive symptoms
timeFrame: 1 month
measure: Misinformation about Covid-19
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Alzheimer Disease Center
state: Massachusetts
Study officials:
affiliation: Professor of Neurology at BU School of Medicine
name: Andrew E Busdon, MD
role: PRINCIPAL_INVESTIGATOR
References: