Trial Outcomes & Findings for Word Retrieval in the Wild in People With Post-Stroke Aphasia (NCT NCT05338216)

Last Updated: 2025-07-08

Results Overview

Compliance will be determined by considering the total number of YES button responses to the "Ready?" screen over the total number of scheduled prompts. This measure will include trials that are missed due to the watch being uncharged or turned off, an important aspect of protocol adherence.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Every day over the three-week at-home smartwatch naming protocol

Results posted on

2025-07-08

Participant Flow

Participants were recruited through (1) postings at local hospitals and clinics that serve individuals with neurogenic communication disorders (2), distribution of study information to healthcare professionals, (3) onsite presentations at community support groups (with staff permission), (4) postings on social media, and (5) existing pipelines within the The Aphasia Network Lab at Northeastern University.

Before completing the ecological momentary assessment protocol, participants underwent cognitive testing, including an assessment to quantify overall aphasia severity (Quick Aphasia Battery \[QAB\], Wilson et al., 2018). From the QAB, a total aphasia score was derived. Using this score, the research team pseudorandomly assigned subjects with aphasia to the arms to balance for aphasia severity.

Participant milestones

Participant milestones
Measure	Traditional Ecological Momentary Assessment (Traditional EMA) For three weeks, participants were instructed to wear a smartwatch provided to them by the study team between 10am and 8pm. Each day during these hours, the smartwatch vibrated and chimed, alerting them to a screen that appeared on the watch that read "Ready to name some pictures?" If the participants selected the "No" button, the trial flow ended and they were reprompted once more for that prompt 10 minutes later. If they selected the "Yes" button, a series of nine pictures appeared on the watch, back-to-back which they attempted to name aloud. They had up to 10s to name each picture. Audio was recorded only when the pictures appeared on the screen. After the final picture, they saw a "Thank you" screen, indicating the end of the trial flow. Participants were scheduled to receive 4 prompts per day for the three weeks. They completed cognitive testing before and after the EMA period. During the EMA period, they also completed a weekly check-in (over email, phone or video conference software) and were asked to complete a brief 15-questionnaire Qualtrics survey about their EMA experiences that week.	Micro-Interaction Ecological Momentary Assessment (µEMA) For three weeks, participants were instructed to wear a smartwatch provided to them by the study team between 10am and 8pm. Each day during these hours, the smartwatch vibrated and chimed, alerting them to a screen that appeared on the watch that read "Ready to name some pictures?" If the participants selected the "No" button, the trial flow ended and they were reprompted once more for that prompt 10 minutes later. If they selected the "Yes" button, a picture appeared on the watch, which they attempted to name aloud. They had up to 10s to name the picture. Audio was recorded only when the picture appeared on the screen. After the picture, they saw a "Thank you" screen, indicating the end of the trial flow. Participants were scheduled to receive 36 prompts per day for the three weeks. They completed cognitive testing before and after the EMA period. During the EMA period, they also completed a weekly check-in (over email, phone or video conference software) and were asked to complete a brief 15-questionnaire Qualtrics survey about their EMA experiences that week.
Overall Study STARTED	8	8
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Traditional Ecological Momentary Assessment (Traditional EMA) For three weeks, participants were instructed to wear a smartwatch provided to them by the study team between 10am and 8pm. Each day during these hours, the smartwatch vibrated and chimed, alerting them to a screen that appeared on the watch that read "Ready to name some pictures?" If the participants selected the "No" button, the trial flow ended and they were reprompted once more for that prompt 10 minutes later. If they selected the "Yes" button, a series of nine pictures appeared on the watch, back-to-back which they attempted to name aloud. They had up to 10s to name each picture. Audio was recorded only when the pictures appeared on the screen. After the final picture, they saw a "Thank you" screen, indicating the end of the trial flow. Participants were scheduled to receive 4 prompts per day for the three weeks. They completed cognitive testing before and after the EMA period. During the EMA period, they also completed a weekly check-in (over email, phone or video conference software) and were asked to complete a brief 15-questionnaire Qualtrics survey about their EMA experiences that week.	Micro-Interaction Ecological Momentary Assessment (µEMA) For three weeks, participants were instructed to wear a smartwatch provided to them by the study team between 10am and 8pm. Each day during these hours, the smartwatch vibrated and chimed, alerting them to a screen that appeared on the watch that read "Ready to name some pictures?" If the participants selected the "No" button, the trial flow ended and they were reprompted once more for that prompt 10 minutes later. If they selected the "Yes" button, a picture appeared on the watch, which they attempted to name aloud. They had up to 10s to name the picture. Audio was recorded only when the picture appeared on the screen. After the picture, they saw a "Thank you" screen, indicating the end of the trial flow. Participants were scheduled to receive 36 prompts per day for the three weeks. They completed cognitive testing before and after the EMA period. During the EMA period, they also completed a weekly check-in (over email, phone or video conference software) and were asked to complete a brief 15-questionnaire Qualtrics survey about their EMA experiences that week.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

One participant in the Traditional (9-item) arm withdrew from the study before completing this assessment.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Every day over the three-week at-home smartwatch naming protocol

Outcome measures

Outcome measures
Measure	Traditional Ecological Momentary Assessment (Traditional EMA) n=7 Participants People with aphasia (PWA) in the traditional EMA arm will receive four prompts per day to complete a set of nine picture naming trials per prompt for a total of n = 36 prompts/day for three weeks.	Micro-Interaction Ecological Momentary Assessment (µEMA) n=7 Participants People with aphasia (PWA) in the µEMA condition will complete a single naming trial at a time, 36 times per day for three weeks.
Change in Protocol Compliance	67.35 Percent response/n scheduled prompts Standard Deviation 19.88	86.98 Percent response/n scheduled prompts Standard Deviation 8.61

PRIMARY outcome

Timeframe: Every day over the three-week at-home smartwatch naming protocol

Population: Two participants (one in each arm) withdrew from the study before completing the EMA period, resulting in seven participants per arm with data to analyze.

Completion will reflect participants' ability to adhere to each step of the smartwatch prompt, including pressing the YES button to the "Ready?", looking at the pictured object(s), and attempting to name the picture(s) aloud. Completion will be determined by considering the total number of naming attempts (indexed by the number of trials for which the participants' voice is audible on the audio recording, disregarding intelligibility of the response) over the total number of prompts delivered to the watch; this measure will exclude trials that are missed due to the watch being uncharged or off.

Outcome measures

Outcome measures
Measure	Traditional Ecological Momentary Assessment (Traditional EMA) n=7 Participants People with aphasia (PWA) in the traditional EMA arm will receive four prompts per day to complete a set of nine picture naming trials per prompt for a total of n = 36 prompts/day for three weeks.	Micro-Interaction Ecological Momentary Assessment (µEMA) n=7 Participants People with aphasia (PWA) in the µEMA condition will complete a single naming trial at a time, 36 times per day for three weeks.
Change in Protocol Completion	75.13 Percent response/n delivered prompts Standard Deviation 13.16	92.47 Percent response/n delivered prompts Standard Deviation 6.24

PRIMARY outcome

Timeframe: Every day over the three-week at-home smartwatch naming protocol

An objective measure of speech intelligibility of audio recordings will be obtained by SLP graduate student RAs manually coding each picture naming audio clip. While the task is a single-word naming task, PWA often produce more than one word in their attempt to name a picture (e.g., "uh asparagus no um green…um bean!" to a picture of bean). It is possible that only part of a multi-word response will be intelligible. Audio clips will be coded as being either completely intelligible (1) or partially/completely unintelligible (0). For each participant, the percentage of intelligible responses will be calculated using the following formula: (\[sum of intelligible responses\] / \[sum of all responses\])\*100.

Outcome measures

Outcome measures
Measure	Traditional Ecological Momentary Assessment (Traditional EMA) n=3 Participants People with aphasia (PWA) in the traditional EMA arm will receive four prompts per day to complete a set of nine picture naming trials per prompt for a total of n = 36 prompts/day for three weeks.	Micro-Interaction Ecological Momentary Assessment (µEMA) n=3 Participants People with aphasia (PWA) in the µEMA condition will complete a single naming trial at a time, 36 times per day for three weeks.
Change in Audio Intelligibility	87.08 Percent Standard Deviation 9.12	88.23 Percent Standard Deviation 3.55

SECONDARY outcome

Timeframe: Once per week over the three-week at-home smartwatch naming protocol

Population: Two participants (one from each arm) withdrew from the study before completing the EMA period. Two additional participants in the traditional arm did not complete Likert scale questions during weekly surveys, resulting in missing data.

A subjective measure of patients' perceived burden of completing the µEMA or EMA protocol will be derived from responses to three questions (pertaining to interruption, annoyance, and distraction from the smartwatch) on three weekly Qualtrics surveys. The responses will be given using a Likert scale, where 1 = strongly agree, 2 = agree, 3 = neither agree or disagree, 4 = disagree, and 5 = strongly disagree. Lower ratings indicate more burden (i.e., higher interruption, annoyance, distraction) and higher ratings indicate less burden. The ratings on these questions will be averaged across each survey for each participant, yielding a single burden rating.

Outcome measures

Outcome measures
Measure	Traditional Ecological Momentary Assessment (Traditional EMA) n=5 Participants People with aphasia (PWA) in the traditional EMA arm will receive four prompts per day to complete a set of nine picture naming trials per prompt for a total of n = 36 prompts/day for three weeks.	Micro-Interaction Ecological Momentary Assessment (µEMA) n=7 Participants People with aphasia (PWA) in the µEMA condition will complete a single naming trial at a time, 36 times per day for three weeks.
Change in Perceived Burden	4.48 1=strongly agree, 5=strongly disagree Standard Deviation 0.43	4.43 1=strongly agree, 5=strongly disagree Standard Deviation 0.38

Adverse Events

Micro-Interaction Ecological Momentary Assessment (µEMA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Ecological Momentary Assessment (Traditional EMA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin Meier

Northeastern University

Phone: 1 (617) 373-7438

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Traditional Ecological Momentary Assessment (Traditional EMA) n=8 Participants Eight participants with post-stroke aphasia and a history of left hemisphere stroke at least six months prior to the beginning of the study were enrolled into the Traditional (1-item) EMA group.	Micro-Interaction Ecological Momentary Assessment (µEMA) n=8 Participants Eight participants with post-stroke aphasia and a history of left hemisphere stroke at least six months prior to the beginning of the study were enrolled into the Micro (1-item) EMA group.	Total n=16 Participants Total of all reporting groups
Age, Continuous	64.6 years STANDARD_DEVIATION 10.6 • n=8 Participants	62.5 years STANDARD_DEVIATION 7.9 • n=8 Participants	63.6 years STANDARD_DEVIATION 9.1 • n=16 Participants
Sex: Female, Male Female	2 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=16 Participants
Sex: Female, Male Male	6 Participants n=8 Participants	7 Participants n=8 Participants	13 Participants n=16 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=8 Participants	8 Participants n=8 Participants	16 Participants n=16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	2 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=16 Participants
Race (NIH/OMB) White	6 Participants n=8 Participants	8 Participants n=8 Participants	14 Participants n=16 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants
Region of Enrollment United States	8 Participants n=8 Participants	8 Participants n=8 Participants	16 Participants n=16 Participants
Quick Aphasia Battery	7.81 Points STANDARD_DEVIATION 1.68 • n=7 Participants • One participant in the Traditional (9-item) arm withdrew from the study before completing this assessment.	7.57 Points STANDARD_DEVIATION 1.48 • n=8 Participants • One participant in the Traditional (9-item) arm withdrew from the study before completing this assessment.	7.68 Points STANDARD_DEVIATION 1.52 • n=15 Participants • One participant in the Traditional (9-item) arm withdrew from the study before completing this assessment.
Boston Naming Test	45.86 Points STANDARD_DEVIATION 13.7 • n=7 Participants • One participant in the Traditional (9-item) arm withdrew from the study before completing this assessment.	42.25 Points STANDARD_DEVIATION 23.30 • n=8 Participants • One participant in the Traditional (9-item) arm withdrew from the study before completing this assessment.	43.93 Points STANDARD_DEVIATION 18.86 • n=15 Participants • One participant in the Traditional (9-item) arm withdrew from the study before completing this assessment.
NIH Cognition Toolbox Pattern Comparison Processing Speed Test	71.43 Age-Corrected Standard Score STANDARD_DEVIATION 18.72 • n=7 Participants • Two participants (one in each arm) withdrew from the study before completing this assessment.	84.14 Age-Corrected Standard Score STANDARD_DEVIATION 16.93 • n=7 Participants • Two participants (one in each arm) withdrew from the study before completing this assessment.	77.79 Age-Corrected Standard Score STANDARD_DEVIATION 18.37 • n=14 Participants • Two participants (one in each arm) withdrew from the study before completing this assessment.
NIH Cognition Toolbox Flanker Attention and Inhibitory Control Test	73.50 Age-Corrected Standard Score STANDARD_DEVIATION 7.77 • n=7 Participants • Two participants (one in each arm) withdrew from the study before completing this assessment.	72.14 Age-Corrected Standard Score STANDARD_DEVIATION 13.30 • n=7 Participants • Two participants (one in each arm) withdrew from the study before completing this assessment.	72.77 Age-Corrected Standard Score STANDARD_DEVIATION 10.68 • n=14 Participants • Two participants (one in each arm) withdrew from the study before completing this assessment.