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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Other: Intervention (videoconferencing)

• Registration Number: NCT04717479
• Lead Sponsor: University of Michigan

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.

Detailed Description

Aim 1: Conduct a user-centered design process to refine the SPEAK! training protocols for older adults with symptoms of SCD/MCI and ELLs, and the materials that will support productive engaging English conversation practice.

Aim 2: Conduct a randomized, wait-list controlled trial of 8 weeks of SPEAK! participation, using a variety of recruitment sources, in order to evaluate our capacity to recruit, implement the intervention, and retain older adults with symptoms of SCD/MCI in sufficient numbers for a subsequent randomized-controlled trial evaluating the intervention's impact on participants' psychological well-being, mood, and cognitive functioning.

Aim 3: Using mixed methods, evaluate the communication process between older adults with symptoms of SCD/MCI and ELLs including factors that contribute to satisfaction of both parties, engagement in planned contacts, possible contributors to stress or dissatisfaction, and perceptions among older adults of being appreciated and effective. The investigators will also estimate variances for key outcome variables and conduct exploratory analyses of intervention-control differences in participants' perceptions of their wellbeing, mood, and cognitive functioning.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-03-19
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Results First Submitted: 2023-04-11
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Results First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 55+ 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait-list Control	Intervention (videoconferencing)	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.
Intervention	Intervention (videoconferencing)	Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.

Primary Outcome Measures

Name	Time	Method
Number of MCI/SCD (Mild Cognitive Impairment/Subjective Cognitive Decline) Participants Recruited Within the First Six Months	Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings).	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.

Trial Locations

Locations (1)

University of Michigan, North Campus Research Complex; 🇺🇸 Ann Arbor, Michigan, United States