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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480112
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Boston University

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.

Condition or disease Intervention/treatment Phase
Memory Disorders Alzheimer Disease Mild Cognitive Impairment Behavioral: Technology based social interactions Other: No research related technology based social interactions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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.

Masking: Single (Outcomes Assessor)
Masking Description: Trial investigators and outcome assessors will be blind to the treatment randomization and allocation..
Primary Purpose: Other
Official Title: Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in memory performance [ Time Frame: Baseline,1 month ]
    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.

  2. Change in cognition [ Time Frame: Baseline, 1 month ]
    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.

  3. Change in phonemic fluency [ Time Frame: Baseline, 1 month ]
    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.


Secondary Outcome Measures :
  1. Social isolation [ Time Frame: 1 month ]
    The 6-item version of the Lubben Social Network scale (LSNS-6) will be used to assess social isolation. For each of the 6 questions the participant rates from 0 to 5 their perceived social engagement where 0=less social engagement and 5= more social engagement. The summed total score ranges between 0 and 30. Lower total scores indicate more social isolation.

  2. Loneliness [ Time Frame: 1 month ]
    Loneliness will be assessed using the UCLA loneliness scale. Participants rate each item as either O ("I often feel this way"= 3),S ("I sometimes feel this way"=2), R ("I rarely feel this way"=1), N ("I never feel this way"=0). A total score is computed by adding up the response to each question and can range from 0 to 60. The average loneliness score on the measure is 20. A score of 25 or higher reflects a high level of loneliness. A score of 30 or higher reflects a very high level of loneliness.

  3. Depressive symptoms [ Time Frame: 1 month ]
    The Geriatric Depression Scale (GDS) will be used to assess depression. It consists of 15 questions- 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

  4. Misinformation about Covid-19 [ Time Frame: 1 month ]
    An investigator developed questionnaire based on survey results published by Geldsetzer P in Annals of Internal Medicine, 3-2020 will be used to assess Covid-19 misinformation.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480112


Locations
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United States, Massachusetts
Boston University Alzheimer Disease Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Andrew E Busdon, MD Professor of Neurology at BU School of Medicine
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT04480112    
Other Study ID Numbers: H-26786
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
Social Isolation
Cognition
Misinformation
Additional relevant MeSH terms:
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Alzheimer Disease
Memory Disorders
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations