Impact of Covid-19 on Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults

NCT ID: NCT04480112

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2021-06-11

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.

Conditions

Memory Disorders; Alzheimer Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Technology based social interactions

Intervention Type: BEHAVIORAL

Participants will be socially interacting using any available technology with members of the research team.

Group B Control

Participants in Group B will not receive any new interventions.

Group Type: ACTIVE_COMPARATOR

No research related technology based social interactions

Intervention Type: OTHER

No technology based social interactions with the research team.

Interventions

Technology based social interactions

Participants will be socially interacting using any available technology with members of the research team.

Intervention Type: BEHAVIORAL

No research related technology based social interactions

No technology based social interactions with the research team.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew E Busdon, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Neurology at BU School of Medicine

Locations

Boston University Alzheimer Disease Center

Boston, Massachusetts, United States

Countries

United States

References

Vives-Rodriguez AL, Marin A, Schiloski KA, Hajos GP, Di Crosta A, Ceccato I, La Malva P, Anderson DC, Lahdo N, Donnelly K, Dong J, Kasha S, Rooney C, Dayaw J, Marton G, Wack A, Hanger V, DeCaro R, Di Domenico A, Turk KW, Palumbo R, Budson AE. Impact of remote social interaction during the COVID-19 pandemic on the cognitive and psychological status of older adults with and without cognitive impairment: A randomized controlled study. PLoS One. 2024 Nov 12;19(11):e0311792. doi: 10.1371/journal.pone.0311792. eCollection 2024.

Reference Type: DERIVED

PMID: 39531433 (View on PubMed)

Other Identifiers

H-26786

Identifier Type: -

Identifier Source: org_study_id