- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04480112
Impact of Covid-19 on Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults
Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston University Alzheimer Disease Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / 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
|
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.
|
No technology based social interactions with the research team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline,1 month
|
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.
|
Baseline, 1 month
|
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.
|
Baseline, 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
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.
|
1 month
|
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.
|
1 month
|
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.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew E Busdon, MD, Professor of Neurology at BU School of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-26786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on Technology based social interactions
-
NYU Langone HealthCompletedObesity | Type 2 Diabetes | Chronic Kidney Disease (CKD)United States
-
Wings Health AGUniversity Hospital, Basel, SwitzerlandRecruitingProstate Cancer | Psychosocial StressorSwitzerland
-
Medical College of WisconsinCompleted
-
Susan LutgendorfUniversity of Miami; University of Iowa; University of WashingtonRecruiting
-
Vanessa OlbrechtNational Center for Complementary and Integrative Health (NCCIH)Enrolling by invitationPain | Pain, Postoperative | Surgery | Pain, AcuteUnited States
-
Laura Nieto RiveiroCompleted
-
Stanford UniversityCompletedStress, EmotionalUnited States
-
Holland Bloorview Kids Rehabilitation HospitalUniversity of Alberta; University of Toronto; Dalhousie University; IWK Health... and other collaboratorsRecruitingAutism Spectrum Disorder | Social Communication Disorder | Autism-Related Speech Delay | Autism Spectrum Disorder With Impaired Functional Language | Autism or Autistic TraitsCanada
-
Virginia Commonwealth UniversityCompletedPregnancy RelatedUnited States
-
Stanford UniversityCompletedBehavioral Symptoms | Stress, Psychological | Stress, EmotionalUnited States