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Clinical Trials/NCT04717479
NCT04717479CompletedNot Applicable

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

University of Michigan1 site in 1 country80 target enrollmentStarted: March 19, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Number of MCI/SCD (Mild Cognitive Impairment/Subjective Cognitive Decline) Participants Recruited Within the First Six Months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Mild Cognitive Impairment participant --
  • •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.

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.

Arms & Interventions

Intervention

Other

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

Intervention: Intervention (videoconferencing) (Other)

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.

Intervention: Intervention (videoconferencing) (Other)

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Piette

Professor of Health Behavior and Health Education, and of Internal Medicine

University of Michigan

Study Sites (1)

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