Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Crossover Assignment
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
Masking
Single (Outcomes Assessor)
Masking Description
Trial investigators and outcome assessors will be blind to the treatment randomization and allocation..

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A Intervention
Participants in Group A will receive an intervention designed to provide participants with more social interaction during a time of social distancing and highly limited in-person social interactions
  • Behavioral: Technology based social interactions
    Participants will be socially interacting using any available technology with members of the research team.
Active Comparator
Group B Control
Participants in Group B will not receive any new interventions.
  • Other: No research related technology based social interactions
    No technology based social interactions with the research team.

More Details

Status
Enrolling by invitation
Sponsor
Boston University

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.