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NCT02871921: I-CONECT

Internet-based Conversational Engagement Clinical Trial

Completed NA Results posted Last updated 2 April 2024
What this trial tests

NA trial testing Conversational Engagement in Aging in 186 participants. Completed in 31 August 2021.

Timeline
1 June 2018
Primary endpoint
31 August 2021
31 August 2021

Quick facts

Lead sponsorMassachusetts General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment186
Start date1 June 2018
Primary completion31 August 2021
Estimated completion31 August 2021
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

75 and older, any sex, with Aging or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention Efficacy for High Dose : Global Cognitive Function as Calculated From the Change From Baseline to Month 6 Primary · Change from baseline to month 6

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.

Pre-pandemic cohort MoCA
GroupValue95% CI
Conversational Engagement (NC)0.40± 2.27
Control Group (NC)0.07± 2.34
Conversational Engagement (MCI)1.46± 2.11
Control Group (MCI)-0.44± 2.04
Pre- and post-pandemic combined cohorts combined
GroupValue95% CI
Conversational Engagement (NC)-0.28± 2.30
Control Group (NC)0.31± 2.25
Conversational Engagement (MCI)1.37± 3.04
Control Group (MCI)0.22± 2.33
Intervention Efficacy for High Dose: Language-based Executive Function Secondary · Change from baseline to month 6

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.

GroupValue95% CI
Conversational Engagement (NC)1.06± 4.24
Control Group (NC)-0.46± 4.30
Conversational Engagement (MCI)-0.42± 3.96
Control Group (MCI)-0.59± 4.11
Intervention Efficacy for High Dose: Learning Function Secondary · Change from baseline to month 6

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. Scores reported are the mean change in score.

GroupValue95% CI
Conversational Engagement (NC)-.58± 3.58
Control Group (NC).63± 3.45
Conversational Engagement (MCI).73± 3.51
Control Group (MCI).95± 3.76
Intervention Efficacy for High Dose: Memory Function Secondary · Change from baseline to month 6

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. Scores are reported as a change score.

GroupValue95% CI
Conversational Engagement (NC)-.26± 3.88
Control Group (NC).74± 3.37
Conversational Engagement (MCI)1.48± 4.47
Control Group (MCI)1.08± 3.56

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over 2 years, from baseline to follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Conversational Engagement (MCI)
Serious: 0/51 (0%)
Deaths: 0/51
Control Group (MCI)
Serious: 0/49 (0%)
Deaths: 0/49
Conversational Engagement (NC)
Serious: 0/43 (0%)
Deaths: 0/43
Control Group(NC)
Serious: 0/43 (0%)
Deaths: 0/43
Other adverse events (2 terms — click to expand)

ReactionSystemConversational Engagement …Control Group (MCI)Conversational Engagement …Control Group(NC)
FatigueNervous system disorders
Stomach acheGastrointestinal disorders

Data from ClinicalTrials.gov NCT02871921 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The FDA-approved anti-amyloid-β monoclonal antibodies for the treatment of Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials.
    Wu W, Ji Y, Wang Z, Wu X, et al · · 2023 · cited 81× · PMID 38017568 · DOI 10.1186/s40001-023-01512-w
  2. 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.
    Dodge HH, Yu K, Wu CY, Pruitt PJ, et al · · 2024 · cited 30× · PMID 37935416 · DOI 10.1093/geront/gnad147
  3. 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.
    Yu K, Wild K, Potempa K, Hampstead BM, et al · · 2021 · cited 23× · PMID 34713183 · DOI 10.3389/fdgth.2021.714813
  4. Emotional characteristics of socially isolated older adults with MCI using tablet administered NIH toolbox: I-CONECT study.
    Yu K, Wild K, Dowling NM, Kaye JA, et al · · 2022 · cited 13× · PMID 36381558 · DOI 10.1002/dad2.12372
  5. Can changes in social contact (frequency and mode) mitigate low mood before and during the COVID-19 pandemic? The I-CONECT project.
    Wu CY, Mattek N, Wild K, Miller LM, et al · · 2022 · cited 13× · PMID 34881436 · DOI 10.1111/jgs.17607
  6. The Joint Effects of Acoustic and Linguistic Markers for Early Identification of Mild Cognitive Impairment.
    Tang F, Chen J, Dodge HH, Zhou J. · · 2021 · cited 11× · PMID 35224534 · DOI 10.3389/fdgth.2021.702772
  7. Topic-Based Measures of Conversation for Detecting Mild Cognitive Impairment.
    Chen L, Dodge HH, Asgari M. · · 2020 · cited 10× · PMID 33642674 · DOI 10.18653/v1/2020.nlpmc-1.9
  8. MC-ViViT: Multi-branch Classifier-ViViT to Detect Mild Cognitive Impairment in Older Adults Using Facial Videos.
    Sun J, Dodge HH, Mahoor MH. · · 2024 · cited 8× · PMID 39238945 · DOI 10.1016/j.eswa.2023.121929

Verify or expand the search:

Other recruiting trials for Aging

Currently open trials in the same condition.

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