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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT04717479
Collaborator
National Institute on Aging (NIA) (NIH)
108
1
2
16.2
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention (videoconferencing)
N/A

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
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK!
Actual Study Start Date :
Mar 19, 2021
Actual Primary Completion Date :
Apr 11, 2022
Actual Study Completion Date :
Jul 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention

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

Other: Intervention (videoconferencing)
1 hour videoconferencing sessions over 8 weeks with an English language learner partner.

Other: Wait-list Control

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

Outcome Measures

Primary Outcome Measures

  1. The primary outcome will be a measure of participant recruitment. [Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings).]

    Recruitment rates will be tracked by research staff overall, and within subgroups according to key predictors such as demographics and cognitive functioning.

Other Outcome Measures

  1. Psychological Wellbeing Scale (PWB) [Baseline and follow-up collected after the 8-week intervention time period.]

    The Psychological Wellbeing Scale (PWB) is a validated measure shown to be sensitive to intervention effects. This is a 6 point scale where the minimum is 1 (strongly disagree) and maximum is 6 (strongly agree). Higher scores reflect higher wellbeing.

  2. UCLA Revised Loneliness Scale [Baseline and follow-up collected after the 8-week intervention time period.]

    This is a validated measure of loneliness with an alpha reliability of .94. This is a 4 point scale from 1=never to 4=always (minimum is 1 maximum is 4). Positively worded questions will be reverse-coded so that higher scores mean more loneliness.

  3. Geriatric Depression Scale [Baseline and follow-up collected after the 8-week intervention time period.]

    The Geriatric Depression Scale is a measure of depressive symptoms specifically designed for older adults. The 30 point scale has a minimum of 0 points to maximum 30 points. Higher scores reflect greater depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

English Language Learner participant --

Inclusion Criteria:
  • 18+ years of age 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.

  • basic ability to understand and speak English.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan, North Campus Research Complex Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: John D Piette, PhD, University of Michigan

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
John Piette, Professor of Health Behavior and Health Education, and of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT04717479
Other Study ID Numbers:
  • 1R21AG066644
  • 5R21AG066644-02
First Posted:
Jan 22, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022