A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK!

NCT04717479 | Completed Results DMC

• 2 other identifiers: 1R21AG0666445R21AG066644-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to refine and test a strategy for engaging older adults with symptoms of SCD/MCI (subjective cognitive decline/mild cognitive impairment) as volunteers to help English language learners (ELLs) who live in the US improve their speaking skills via structured conversations using videoconferencing.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Number of MCI/SCD (Mild Cognitive Impairment/Subjective Cognitive Decline) Participants Recruited Within the First Six Months

  The primary aim for Phase 2 of the study was to demonstrate the feasibility of recruiting and consenting a minimum of 35 older adults with MCI/SCD (mild cognitive impairment/subjective cognitive decline) within the first six months.

  Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings).

Other Outcomes (3)

• Psychological Wellbeing Scale (PWB)

  Baseline and follow-up collected after the 8-week intervention time period.

• UCLA Revised Loneliness Scale

  Baseline and follow-up collected after the 8-week intervention time period.

• Geriatric Depression Scale

  Baseline and follow-up collected after the 8-week intervention time period.

Study Arms (2)

Intervention

OTHER

Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.

Other: Intervention (videoconferencing)

Wait-list Control

OTHER

Participants will wait 8 weeks and then they will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.

Other: Intervention (videoconferencing)

Interventions

Intervention (videoconferencing) OTHER

1 hour videoconferencing sessions over 8 weeks with an English language learner partner.

Intervention; Wait-list Control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age, fluent speakers of English of any race/ethnicity, and be able to participate in a videoconference via a smartphone, tablet laptop, or desktop computer in their home or referring organization using a widely accessible, no cost videoconferencing platform.

You may not qualify if:

• Participants will be ineligible if they have a history of stroke or traumatic brain injury, bipolar disorder, schizophrenia, or current alcohol or drug abuse/dependence, that would affect their ability to participate in the study; MoCA score \<12.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan, North Campus Research Complex

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Methods

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Sarah Yon
• Organization: University of Michigan

shlim@umich.edu

734-763-0412

Study Officials

• John D Piette, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Behavior and Health Education, and of Internal Medicine

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: March 19, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-06

Locations

US (1)