Trial Outcomes & Findings for A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK! (NCT NCT04717479)

Last Updated: 2023-07-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings).

Results posted on

2023-07-20

Participant Flow

Goal of recruiting 44 pairs into the waitlist trial for AIMS 2-3.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	41	39
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Information was not obtained for one ELL participant

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Overall n=50 Participants Overall participant recruitment of MCI/SCD (older adults with mild cognitive impairment/subjective cognitive decline) arm of the study within the first six months.
Number of MCI/SCD (Mild Cognitive Impairment/Subjective Cognitive Decline) Participants Recruited Within the First Six Months	35 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=41 participants at risk 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.	Wait-list Control n=39 participants at risk 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.
Surgical and medical procedures Surgery	2.4% 1/41 • Number of events 1 • 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.	0.00% 0/39 • 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.
Vascular disorders Stroke	2.4% 1/41 • Number of events 1 • 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.	0.00% 0/39 • 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.
Injury, poisoning and procedural complications Car accident injury	0.00% 0/41 • 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.	2.6% 1/39 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Sarah Yon

University of Michigan

Phone: 734-763-0412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention n=41 Participants 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.	Wait-list Control n=39 Participants 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.	Total n=80 Participants Total of all reporting groups
Age, Continuous MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline)	70 years STANDARD_DEVIATION 9.49 • n=22 Participants • Information was not obtained for one ELL participant	71 years STANDARD_DEVIATION 8.06 • n=22 Participants • Information was not obtained for one ELL participant	71 years STANDARD_DEVIATION 8.82 • n=44 Participants • Information was not obtained for one ELL participant
Age, Continuous ELL (English Language Learner)	41 years STANDARD_DEVIATION 9.73 • n=19 Participants • Information was not obtained for one ELL participant	43 years STANDARD_DEVIATION 9.07 • n=17 Participants • Information was not obtained for one ELL participant	42 years STANDARD_DEVIATION 9.32 • n=36 Participants • Information was not obtained for one ELL participant
Sex/Gender, Customized MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Female	12 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	16 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	28 Participants n=44 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Sex/Gender, Customized MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Male	10 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	6 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	16 Participants n=44 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Sex/Gender, Customized ELL (English Language Learner) · Female	15 Participants n=19 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	13 Participants n=17 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	28 Participants n=36 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Sex/Gender, Customized ELL (English Language Learner) · Male	4 Participants n=19 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	4 Participants n=17 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	8 Participants n=36 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Ethnicity (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Hispanic or Latino	0 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Ethnicity (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Not Hispanic or Latino	22 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	22 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	44 Participants n=44 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Ethnicity (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Unknown or Not Reported	0 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Ethnicity (NIH/OMB) ELL (English Language Learner) · Hispanic or Latino	11 Participants n=19 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	12 Participants n=17 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	23 Participants n=36 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Ethnicity (NIH/OMB) ELL (English Language Learner) · Not Hispanic or Latino	8 Participants n=19 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	5 Participants n=17 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	13 Participants n=36 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Ethnicity (NIH/OMB) ELL (English Language Learner) · Unknown or Not Reported	0 Participants n=19 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	0 Participants n=17 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants	0 Participants n=36 Participants • Overall population described in two groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · American Indian or Alaska Native	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Asian	2 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	2 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Black or African American	4 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	7 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	11 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · White	16 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	15 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	31 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · More than one race	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Unknown or Not Reported	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) ELL (English Language Learner) · American Indian or Alaska Native	0 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) ELL (English Language Learner) · Asian	4 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	4 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	8 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) ELL (English Language Learner) · Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) ELL (English Language Learner) · Black or African American	1 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	1 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	2 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) ELL (English Language Learner) · White	9 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	10 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	19 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) ELL (English Language Learner) · More than one race	3 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	3 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Race (NIH/OMB) ELL (English Language Learner) · Unknown or Not Reported	2 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	2 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	4 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · 8th grade or less	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL 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 n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · High school graduate or GED	1 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	2 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	3 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL 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 n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	3 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	8 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) · Four-year college graduate	6 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	9 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	15 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL 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 n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	8 Participants n=22 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	18 Participants n=44 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education ELL (English Language Learner) · 8th grade or less	0 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education ELL (English Language Learner) · Some high school,but did not graduate	0 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education ELL (English Language Learner) · High school graduate or GED	0 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	0 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education ELL (English Language Learner) · Some college or two-year college degree	2 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	1 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	3 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education ELL (English Language Learner) · Four-year college graduate	7 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	4 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	11 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants
Highest Degree of Completed Education ELL (English Language Learner) · More than four-year college degree	10 Participants n=19 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	12 Participants n=17 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants	22 Participants n=36 Participants • Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants