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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AG066644-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention (videoconferencing) | Other | 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and follow-up collected after the 8-week intervention time period. |
Mild Cognitive Impairment participant --
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D Piette, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, North Campus Research Complex | Ann Arbor | Michigan | 48109 | United States |
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Goal of recruiting 44 pairs into the waitlist trial for AIMS 2-3.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Wait-list Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2021 |
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| 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. | Baseline and follow-up collected after the 8-week intervention time period. |
| 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. | Baseline and follow-up collected after the 8-week intervention time period. |
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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Information was not obtained for one ELL participant | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Overall population described in two groups: MCI/SCD participants and ELL participants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Overall population described in two groups: MCI/SCD participants and ELL participants | Count of Participants | Participants |
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| Race (NIH/OMB) | Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants | Count of Participants | Participants |
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| Highest Degree of Completed Education | Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | No | Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings). |
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| 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. | Not Posted | Baseline and follow-up collected after the 8-week intervention time period. | Participants | |||||||||||||||||||||||||||||||
| 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. | Not Posted | Baseline and follow-up collected after the 8-week intervention time period. | 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. | Not Posted | Baseline and follow-up collected after the 8-week intervention time period. | Participants |
2 months during recruitment and delivery of the intervention.
Reviewed by staff during our weekly meetings. Same definition as in clinicaltrials.gov.
All serious events were unrelated to the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 41 | 2 | 41 | 0 | 41 |
| EG001 | 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. | 0 | 39 | 1 | 39 | 0 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Stroke | Vascular disorders | Non-systematic Assessment |
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| Car accident injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Yon | University of Michigan | 734-763-0412 | shlim@umich.edu |
| Apr 6, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2022 | Jul 20, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
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| D008722 | Methods |
| ID | Term |
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| D008919 | Investigative Techniques |
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| ELL (English Language Learner) |
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