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Internet-based Conversational Engagement Clinical Trial (I-CONECT)

Primary Purpose

Aging, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conversational Engagement
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Behavioral intervention, social interaction, social isolation, loneliness, dementia, cognitive decline, MRI/fMRI, objective IADL assessment, speech characteristics (acoustic and linguistic), emotional well-being

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 75 or older
  2. Consent to MRI (if physically able to receive one)
  3. Socially isolated, defined by at least one of the following:

    i. Score ≤12 on the 6-item Lubben Social Network Scale (LSNS-6), ii. Engages in conversations lasting 30 minutes or longer no more than twice per week, per subject self-report iii. Answers "Often" to at least one question on the Hughes et al. Three-Item Loneliness Scale

  4. Adequate vision to use study technology and complete all neuropsychological tests throughout the study, defined by the following two criteria:

    i. See well enough to complete the MoCA ii. See well enough to read a newspaper, wearing glasses if needed but not using a magnifying glass

  5. Adequate hearing to use study technology and complete all neuropsychological tests throughout the study, defined as i. Able to hear well enough to complete the telephone screening ii. Able to hear well enough to complete the MoCA
  6. Sufficient ability to understand English in order to complete protocol-required testing
  7. Normal cognition or mild cognitive impairment (MCI), as assessed by the trial neuropsychologist
  8. Sufficiently able to comply with protocol assessments and procedures, in the opinion of the investigator

Exclusion Criteria:

  1. Identified as having dementia based on either of the following criteria:

    i. Self-reported diseases associated with dementia, such as Alzheimer's disease, vascular dementia, Lewy body dementia, front temporal dementia, normal pressure hydrocephalus, or Parkinson's disease ii. Diagnosis of dementia by trial neuropsychologist

  2. Anticipating major change in living arrangement within the upcoming year
  3. Severely depressed, operationally defined as a 15-item GDS score > 7
  4. Significant disease of the central nervous system, such as brain tumor, seizure disorder, subdural hematoma, or significant stroke, per subject report
  5. Current (within 2 years of screening) alcohol or substance abuse
  6. Unstable or significantly symptomatic psychiatric disorder, such as major depression, schizophrenia, posttraumatic stress disorder, or bipolar disorder
  7. Unstable or significantly symptomatic cardiovascular disease, such as coronary artery disease with frequent angina, or congestive heart failure with shortness of breath at rest
  8. Unstable insulin-dependent diabetes mellitus, defined as meeting any of the following criteria:

    i. Received a diagnosis of Type 1 Diabetes ii. Started taking insulin within 3 months of the screening visit iii. Been hospitalized for hypoglycemia within one year of screening

  9. Active systemic cancer within 5 years of the screening visit (Gleason Grade < 3 prostate cancer and non-metastatic skin cancers are acceptable)
  10. Surgery that required full sedation with intubation within 6 months of screening (sedation for minor procedures is acceptable)
  11. More than one overnight hospital stay within 3 months of the screening visit
  12. Any other condition that, in the opinion of the investigator, is severe enough to cause study participation to have a negative impact on participant or study team rights or wellbeing.

Sites / Locations

  • Massachusetts General Hospital
  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Conversational Engagement

Control Group

Arm Description

Participants engage in 30-minute face-to-face communications with study staff through internet/webcam 4 times per week for 24 weeks (6 months). Under an exploratory aim, a limited number of participants will be further followed by sustaining dose of 2 times per week of 30 minutes session for additional 24 weeks (6 months). Conversational staff will facilitate content-standardized but naturalistic-style social engagement. Staff and participants will engage in conversation about a wide variety of topics that are culturally and personally relevant and interesting to participants. Each day, participants will be able to choose from topic options. Participants will also receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions.

Participants will receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions

Outcomes

Primary Outcome Measures

Intervention Efficacy for High Dose : Global Cognitive Function
Global cognitive function measured by the Montreal Cognitive Assessment total score (MoCA total score). Montreal Cognitive Assessment is a neuropsychological test. Total score ranges from 0 to 30. Higher scores indicate better cognitive function.

Secondary Outcome Measures

Intervention Efficacy for High Dose: Language-based executive function
Cognitive function in language-based executive function measured by Verbal Fluency Animal test. Verbal fluency Animals test is a neuropsychological test. In the test, participants have to produce as many words as possible from a category of animals within 60 seconds. Total score ranges from 0 to 70. Higher scores indicate better cognitive function.
Intervention Efficacy for High Dose: learning function
Cognitive function in a learning domain (immediate recall) measured by Craft Story Immediate Recall test (paraphrase scoring). Craft Story Immediate Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function.
Intervention Efficacy for High Dose: Memory function
Cognitive function in a memory domain measured by Craft Story Delayed Recall test scores (paraphrase scoring). Craft Story Delayed Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function.

Full Information

First Posted
August 8, 2016
Last Updated
October 4, 2023
Sponsor
Oregon Health and Science University
Collaborators
University of Michigan, National Institute on Aging (NIA), Wayne State University, Emory University, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02871921
Brief Title
Internet-based Conversational Engagement Clinical Trial
Acronym
I-CONECT
Official Title
Internet-based Conversational Engagement Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
University of Michigan, National Institute on Aging (NIA), Wayne State University, Emory University, Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims to randomize 320 (160 Caucasian, 160 African American) socially isolated adults 75+ years old (50:50 split between those with normal cognition and mild cognitive impairment (MCI)) recruited from the community to either the Video Chat Group or the Control Group. The participants in the Video Chat Group will receive a computer and internet service for the duration of the study, which they will use to video chat with study staff for 30 minutes/day 4x/week for 6 months (high dose), and then 2x/week for an additional 6 months (maintenance dose). The efficacy examination of the maintenance dose is limited to an exploratory aim. Both intervention and control groups will have a brief (about 10 minutes) telephone check-in with study staff once per week. In-home testing will occur at Baseline and 6 months. A sub-sample of participants** will be assessed at 12 months (exploratory) after additional 6 months of maintenance dose. All participants at OHSU will have their medication compliance tracked using an electronic medication monitoring device and participants at both OHSU and UM will have MRIs at Baseline and 6 months, if they are able to safely receive MRIs. Participants at both sites will contribute saliva for genetic testing (optional consent), and all video chat and neuropsychological assessment sessions will be recorded for speech and language analysis (consent required for participation).
Detailed Description
**Due to COVID-19 pandemic and resultant research hiatus and the subsequent changes in assessment modality from in-person to telephone (T-COG) assessments, M12 (Months 12) assessments are conducted only among those who completed M12 assessments before March, 18, 2020.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mild Cognitive Impairment
Keywords
Behavioral intervention, social interaction, social isolation, loneliness, dementia, cognitive decline, MRI/fMRI, objective IADL assessment, speech characteristics (acoustic and linguistic), emotional well-being

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Study assessors will be blinded to the subject study arm assignment.
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conversational Engagement
Arm Type
Experimental
Arm Description
Participants engage in 30-minute face-to-face communications with study staff through internet/webcam 4 times per week for 24 weeks (6 months). Under an exploratory aim, a limited number of participants will be further followed by sustaining dose of 2 times per week of 30 minutes session for additional 24 weeks (6 months). Conversational staff will facilitate content-standardized but naturalistic-style social engagement. Staff and participants will engage in conversation about a wide variety of topics that are culturally and personally relevant and interesting to participants. Each day, participants will be able to choose from topic options. Participants will also receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions
Intervention Type
Behavioral
Intervention Name(s)
Conversational Engagement
Intervention Description
Examine whether increasing social interaction through face-to-face (video chat) conversations could improve cognitive function and whether the efficacy is mediated by improved psychological well-being, targeting older adults aged 75 and older who are socially isolated
Primary Outcome Measure Information:
Title
Intervention Efficacy for High Dose : Global Cognitive Function
Description
Global cognitive function measured by the Montreal Cognitive Assessment total score (MoCA total score). Montreal Cognitive Assessment is a neuropsychological test. Total score ranges from 0 to 30. Higher scores indicate better cognitive function.
Time Frame
Change from baseline to month 6
Secondary Outcome Measure Information:
Title
Intervention Efficacy for High Dose: Language-based executive function
Description
Cognitive function in language-based executive function measured by Verbal Fluency Animal test. Verbal fluency Animals test is a neuropsychological test. In the test, participants have to produce as many words as possible from a category of animals within 60 seconds. Total score ranges from 0 to 70. Higher scores indicate better cognitive function.
Time Frame
Change from baseline to month 6
Title
Intervention Efficacy for High Dose: learning function
Description
Cognitive function in a learning domain (immediate recall) measured by Craft Story Immediate Recall test (paraphrase scoring). Craft Story Immediate Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function.
Time Frame
Change from baseline to month 6
Title
Intervention Efficacy for High Dose: Memory function
Description
Cognitive function in a memory domain measured by Craft Story Delayed Recall test scores (paraphrase scoring). Craft Story Delayed Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function.
Time Frame
Change from baseline to month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 75 or older Consent to MRI (if physically able to receive one) Socially isolated, defined by at least one of the following: i. Score ≤12 on the 6-item Lubben Social Network Scale (LSNS-6), ii. Engages in conversations lasting 30 minutes or longer no more than twice per week, per subject self-report iii. Answers "Often" to at least one question on the Hughes et al. Three-Item Loneliness Scale Adequate vision to use study technology and complete all neuropsychological tests throughout the study, defined by the following two criteria: i. See well enough to complete the MoCA ii. See well enough to read a newspaper, wearing glasses if needed but not using a magnifying glass Adequate hearing to use study technology and complete all neuropsychological tests throughout the study, defined as i. Able to hear well enough to complete the telephone screening ii. Able to hear well enough to complete the MoCA Sufficient ability to understand English in order to complete protocol-required testing Normal cognition or mild cognitive impairment (MCI), as assessed by the trial neuropsychologist Sufficiently able to comply with protocol assessments and procedures, in the opinion of the investigator Exclusion Criteria: Identified as having dementia based on either of the following criteria: i. Self-reported diseases associated with dementia, such as Alzheimer's disease, vascular dementia, Lewy body dementia, front temporal dementia, normal pressure hydrocephalus, or Parkinson's disease ii. Diagnosis of dementia by trial neuropsychologist Anticipating major change in living arrangement within the upcoming year Severely depressed, operationally defined as a 15-item GDS score > 7 Significant disease of the central nervous system, such as brain tumor, seizure disorder, subdural hematoma, or significant stroke, per subject report Current (within 2 years of screening) alcohol or substance abuse Unstable or significantly symptomatic psychiatric disorder, such as major depression, schizophrenia, posttraumatic stress disorder, or bipolar disorder Unstable or significantly symptomatic cardiovascular disease, such as coronary artery disease with frequent angina, or congestive heart failure with shortness of breath at rest Unstable insulin-dependent diabetes mellitus, defined as meeting any of the following criteria: i. Received a diagnosis of Type 1 Diabetes ii. Started taking insulin within 3 months of the screening visit iii. Been hospitalized for hypoglycemia within one year of screening Active systemic cancer within 5 years of the screening visit (Gleason Grade < 3 prostate cancer and non-metastatic skin cancers are acceptable) Surgery that required full sedation with intubation within 6 months of screening (sedation for minor procedures is acceptable) More than one overnight hospital stay within 3 months of the screening visit Any other condition that, in the opinion of the investigator, is severe enough to cause study participation to have a negative impact on participant or study team rights or wellbeing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroko Dodge, PhD
Organizational Affiliation
Oregon Health and Science Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All de-identified subject data will stored in a data repository at the conclusion of the research, and made available to approved investigators per a repository protocol.
IPD Sharing Time Frame
Data will be available once main trial analyses have concluded, and will be available indefinitely.
IPD Sharing Access Criteria
Investigators may access trial data via a repository data sharing request process. Data access will be granted to achieve the aims as outlined in approved data requests. IRB approval may be required.
Citations:
PubMed Identifier
34713183
Citation
Yu K, Wild K, Potempa K, Hampstead BM, Lichtenberg PA, Struble LM, Pruitt P, Alfaro EL, Lindsley J, MacDonald M, Kaye JA, Silbert LC, Dodge HH. The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications. Front Digit Health. 2021 Aug 25;3:714813. doi: 10.3389/fdgth.2021.714813. eCollection 2021.
Results Reference
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PubMed Identifier
35224534
Citation
Tang F, Chen J, Dodge HH, Zhou J. The Joint Effects of Acoustic and Linguistic Markers for Early Identification of Mild Cognitive Impairment. Front Digit Health. 2022 Feb 11;3:702772. doi: 10.3389/fdgth.2021.702772. eCollection 2021.
Results Reference
background
PubMed Identifier
36540960
Citation
Liu G, Xue Z, Zhan L, Dodge HH, Zhou J. Detection of Mild Cognitive Impairment from Language Markers with Crossmodal Augmentation. Pac Symp Biocomput. 2023;28:7-18.
Results Reference
background
PubMed Identifier
33642674
Citation
Chen L, Dodge HH, Asgari M. Topic-Based Measures of Conversation for Detecting Mild Cognitive Impairment. Proc Conf Assoc Comput Linguist Meet. 2020 Jul;2020:63-67.
Results Reference
background
PubMed Identifier
34881436
Citation
Wu CY, Mattek N, Wild K, Miller LM, Kaye JA, Silbert LC, Dodge HH. Can changes in social contact (frequency and mode) mitigate low mood before and during the COVID-19 pandemic? The I-CONECT project. J Am Geriatr Soc. 2022 Mar;70(3):669-676. doi: 10.1111/jgs.17607. Epub 2021 Dec 13.
Results Reference
background
PubMed Identifier
36381558
Citation
Yu K, Wild K, Dowling NM, Kaye JA, Silbert LC, Dodge HH. Emotional characteristics of socially isolated older adults with MCI using tablet administered NIH toolbox: I-CONECT study. Alzheimers Dement (Amst). 2022 Nov 11;14(1):e12372. doi: 10.1002/dad2.12372. eCollection 2022.
Results Reference
background
Citation
Dodge HH, Yu K, Wu C-Y, Pruitt PJ, Asgari M, Kaye JA, Hampstead BH, Struble L, Potempa K, Lichtenberg P, Croff R, Albin RL, Silbert LC, and the I-CONECT team. Internet-based conversational engagement randomized controlled clinical trial (I-CONECT) among socially isolated adults 75+ years old with normal cognition or MCI: topline results. The Gerontologists. In Press (PMC in process)
Results Reference
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Links:
URL
http://www.i-conect.org
Description
Study Website

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Internet-based Conversational Engagement Clinical Trial

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