Memory DisordersNCT04480112
Impact of Covid-19 on Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults
A study testing Technology based social interactions and No research related technology based social interactions in people with Memory Disorders and Alzheimer Disease, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Memory Disorders, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Technology based social interactions and No research related technology based social interactions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2020to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Alzheimer Disease Center
Boston, Massachusetts, 02118
About this study
Official title: Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment
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.
Read the 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.
- Being tested
- Technology based social interactions, No research related technology based social interactions
- Keywords
- Social Isolation, Cognition, Misinformation
- Medical subject headings
- Memory Disorders, Alzheimer Disease, Cognitive Dysfunction, Social Isolation, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology based social interactionsBehavioural
Participants will be socially interacting using any available technology with members of the research team.
No research related technology based social interactionsOther
No technology based social interactions with the research team.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Technology based social interactions |
| Group B Control | Active comparator | Participants in Group B will not receive any new interventions. Receives: Other: No research related technology based social interactions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month
Secondary outcomes (4)
Social isolation
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.
Measured: 1 month
Loneliness
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.
Measured: 1 month
Depressive symptoms
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.
Measured: 1 month
Misinformation about Covid-19
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start2 Jun 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew E Busdon, MD, Principal investigator, Professor of Neurology at BU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480112
- Sponsor's protocol ID
- H-26786
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39531433
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04480112
- Acronym / sponsor ID
- H-26786
- Keywords
- Social Isolation, Cognition, Misinformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A Intervention | Experimental | Behavioral: Technology based social interactionsParticipants 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 B Control | Active comparator | Other: No research related technology based social interactionsParticipants in Group B will not receive any new interventions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology based social interactionsParticipants will be socially interacting using any available technology with members of the research team. | Behavioural | Group A Intervention |
| No research related technology based social interactionsNo technology based social interactions with the research team. | Other | Group B Control |
Primary outcome
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.
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.
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.
4 secondary outcomes
Social isolation
Time frame: 1 month
Loneliness
Time frame: 1 month
Depressive symptoms
Time frame: 1 month
Misinformation about Covid-19
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 39531433Vives-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew E Busdon, MD principal investigator
Professor of Neurology at BU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology based social interactions and No research related technology based social interactions in people with Memory Disorders and Alzheimer Disease, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in memory performance (time frame: Baseline,1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.