Internet-based Conversational Engagement Clinical Trial

NCT ID: NCT02871921

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-08-31

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.

Conditions

Aging; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conversational Engagement

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.

Group Type: EXPERIMENTAL

Conversational Engagement

Intervention Type: BEHAVIORAL

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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Conversational Engagement

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hiroko Hayama Dodge

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hiroko Dodge, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science Univeristy

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 34713183 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35224534 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36540960 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33642674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34881436 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36381558 (View on PubMed)

Dodge HH, Yu K, Wu CY, Pruitt PJ, Asgari M, Kaye JA, Hampstead BM, Struble L, Potempa K, Lichtenberg P, Croff R, Albin RL, Silbert LC; I-CONECT Team. Internet-Based Conversational Engagement Randomized Controlled Clinical Trial (I-CONECT) Among Socially Isolated Adults 75+ Years Old With Normal Cognition or Mild Cognitive Impairment: Topline Results. Gerontologist. 2024 Apr 1;64(4):gnad147. doi: 10.1093/geront/gnad147.

Reference Type: RESULT

PMID: 37935416 (View on PubMed)

Wu CY, Chen L, Dickson JR, Zhang B, Arnold SE, Dodge HH. Synthetic control methods for n-of-1 and parallel-group trials in Alzheimer's disease: A proof-of-concept study using the I-CONECT. Alzheimers Dement. 2025 Jul;21(7):e70460. doi: 10.1002/alz.70460.

Reference Type: DERIVED

PMID: 40621876 (View on PubMed)

Yuan F, Zhou W, Dodge HH, Zhao X. Short: Causal structural learning of conversational engagement for socially isolated older adults. Smart Health (Amst). 2023 Jun;28:100384. doi: 10.1016/j.smhl.2023.100384. Epub 2023 Mar 21.

Reference Type: DERIVED

PMID: 37065441 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.i-conect.org

Study Website

Other Identifiers

R56AG056102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AG051628

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AG056102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023p000367

Identifier Type: -

Identifier Source: org_study_id