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

NCT04480112 | Completed

• 1 other identifier: H-26786
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Disorders; Alzheimer Disease; Mild Cognitive Impairment

Keywords

Social Isolation; Cognition; Misinformation

Outcome Measures

Primary Outcomes (3)

• Change in memory performance

  The Oral Trail Making Test B (TMT-B) will be used to assess memory performance. It is a neuropsychological measure that provides an assessment of sequential set-shifting. Participants are asked to count from 1 to 25 switching between number and letter, eg 1-A-2-B-3-C, until stopped.

  Baseline,1 month

• Change in cognition

  Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS) will be administered to assess cognitive decline or improvement. The 12 items on the RBANS assess five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. Scores can range from 0-160 and are interpreted as: 130 and above- very superior; 120-129 - superior; 110-119- high average; 90-109- average; 80-89- low average; 70-79- borderline; 60 and below extremely low.

  Baseline, 1 month

• Change in phonemic fluency

  Phonemic fluency will be assessed by asking participants to produce orally as many words as possible beginning with a specific letter or for a specific category (eg animals, fruits, etc). The test consists of three trials, of 1 min each. The higher the number of words provided, the greater the verbal fluency.

  Baseline, 1 month

Secondary Outcomes (4)

• Social isolation

  1 month

• Loneliness

  1 month

• Depressive symptoms

  1 month

• Misinformation about Covid-19

  1 month

Study Arms (2)

Group A Intervention

EXPERIMENTAL

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

Group B Control

ACTIVE COMPARATOR

Participants in Group B will not receive any new interventions.

Other: No research related technology based social interactions

Interventions

Technology based social interactions BEHAVIORAL

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

Group A Intervention

No research related technology based social interactions OTHER

No technology based social interactions with the research team.

Group B Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University Alzheimer Disease Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 39531433 DERIVED

MeSH Terms

Conditions

Memory Disorders; Alzheimer Disease; Cognitive Dysfunction; Social Isolation; Communication

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Social Behavior; Behavior

Study Officials

• Andrew E Busdon, MD

  Professor of Neurology at BU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trial investigators and outcome assessors will be blind to the treatment randomization and allocation..
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 21, 2020
• Study Start: June 2, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)