Mild Cognitive Impairment
Conditions
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.
Interventions
1 hour videoconferencing sessions over 8 weeks with an English language learner partner.
Sponsors
National Institute on Aging (NIA)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Goal of recruiting 44 pairs into the waitlist trial for AIMS 2-3.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.
Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. | 41 |
| 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.
Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. | 39 |
| Total | 80 |
Baseline characteristics
| Characteristic | Intervention | Wait-list Control | Total |
|---|---|---|---|
| Age, Continuous ELL (English Language Learner) | 41 years STANDARD_DEVIATION 9.73 | 43 years STANDARD_DEVIATION 9.07 | 42 years STANDARD_DEVIATION 9.32 |
| Age, Continuous MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) | 70 years STANDARD_DEVIATION 9.49 | 71 years STANDARD_DEVIATION 8.06 | 71 years STANDARD_DEVIATION 8.82 |
| Ethnicity (NIH/OMB) ELL (English Language Learner) Hispanic or Latino | 11 Participants | 12 Participants | 23 Participants |
| Ethnicity (NIH/OMB) ELL (English Language Learner) Not Hispanic or Latino | 8 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) ELL (English Language Learner) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Not Hispanic or Latino | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree of Completed Education ELL (English Language Learner) 8th grade or less | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree of Completed Education ELL (English Language Learner) Four-year college graduate | 7 Participants | 4 Participants | 11 Participants |
| Highest Degree of Completed Education ELL (English Language Learner) High school graduate or GED | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree of Completed Education ELL (English Language Learner) More than four-year college degree | 10 Participants | 12 Participants | 22 Participants |
| Highest Degree of Completed Education ELL (English Language Learner) Some college or two-year college degree | 2 Participants | 1 Participants | 3 Participants |
| Highest Degree of Completed Education ELL (English Language Learner) Some high school,but did not graduate | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) 8th grade or less | 0 Participants | 0 Participants | 0 Participants |
| Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Four-year college graduate | 6 Participants | 9 Participants | 15 Participants |
| Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) High school graduate or GED | 1 Participants | 2 Participants | 3 Participants |
| Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) More than four-year college degree | 10 Participants | 8 Participants | 18 Participants |
| Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Some college or two-year college degree | 5 Participants | 3 Participants | 8 Participants |
| Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Some high school,but did not graduate | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) ELL (English Language Learner) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) ELL (English Language Learner) Asian | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) ELL (English Language Learner) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) ELL (English Language Learner) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) ELL (English Language Learner) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) ELL (English Language Learner) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) ELL (English Language Learner) White | 9 Participants | 10 Participants | 19 Participants |
| Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Black or African American | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) White | 16 Participants | 15 Participants | 31 Participants |
| Sex/Gender, Customized ELL (English Language Learner) Female | 15 Participants | 13 Participants | 28 Participants |
| Sex/Gender, Customized ELL (English Language Learner) Male | 4 Participants | 4 Participants | 8 Participants |
| Sex/Gender, Customized MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Female | 12 Participants | 16 Participants | 28 Participants |
| Sex/Gender, Customized MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 2 / 41 | 1 / 39 |
Outcome results
Primary
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.
Time frame: Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings).
Population: The overall number of participants analyzed refers to the 50 participants that were screened in the first 6 months, from which 35 participants were enrolled in the first 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Number of MCI/SCD (Mild Cognitive Impairment/Subjective Cognitive Decline) Participants Recruited Within the First Six Months | 35 Participants |
Other Pre-specified
Geriatric Depression Scale
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.
Time frame: Baseline and follow-up collected after the 8-week intervention time period.
Other Pre-specified
Psychological Wellbeing Scale (PWB)
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.
Time frame: Baseline and follow-up collected after the 8-week intervention time period.
Other Pre-specified
UCLA Revised Loneliness Scale
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.
Time frame: Baseline and follow-up collected after the 8-week intervention time period.