Trial Outcomes & Findings for Strategy Training for People With Aphasia After Stroke (NCT NCT03593876)

Last Updated: 2021-09-24

Results Overview

Measure of Participation in Conversation (MPC) Interaction score greater than or equal to 2. The scale assesses the degree of participation executed by the participant with communication impairment during supported conversation. Scores range from 0=no participation/comprehension to 4=full participation/comprehension.

Recruitment status

TERMINATED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Baseline to Post-Intervention (up to 3 weeks)

Results posted on

2021-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Strategy Training Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol.
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Strategy Training Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol.
Overall Study Withdrawal by Subject	1
Overall Study Discharged home before intervention completion	2

Baseline Characteristics

Strategy Training for People With Aphasia After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Strategy Training n=16 Participants Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol.
Age, Continuous	71.5 years STANDARD_DEVIATION 9.9 • n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	14 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	16 Participants n=99 Participants
Comorbidity, Charlson Comorbidity Index	2.3 total score STANDARD_DEVIATION 1.7 • n=99 Participants
Chronicity, Days since stroke	25.6 days STANDARD_DEVIATION 27.6 • n=99 Participants
Stroke Hemisphere, Left	13 participants n=99 Participants
Inpatient Rehabilitation Length of Stay, Days	22.5 days STANDARD_DEVIATION 9.6 • n=99 Participants
Aphasia Severity, Boston Diagnostic Aphasia Examination Severity Scale	1.9 total score STANDARD_DEVIATION 1.1 • n=99 Participants
Stroke Severity, National Institutes of Health Stroke Scale	8.6 total score STANDARD_DEVIATION 5.2 • n=99 Participants
Disability, Functional Independence Measure	52.4 total score STANDARD_DEVIATION 21.0 • n=99 Participants
Cognitive Linguistic Quick Test Executive Function Score	12.6 composite score STANDARD_DEVIATION 7.2 • n=99 Participants

PRIMARY outcome

Timeframe: Baseline to Post-Intervention (up to 3 weeks)

Outcome measures

Outcome measures
Measure	Strategy Training n=13 Participants Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol.
Mean Patient-therapist Communication Score	3.0 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline to 6 months

Change in independence measured with the Functional Independence Measure. The FIM assesses 18 tasks in 6 functional domains (self-care, sphincter control, transfers, locomotion, communication and social cognition) using a scale of 1 (dependent) to 7 (independent). Scores range from 18 to 126. Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5).

Outcome measures

Outcome measures
Measure	Strategy Training n=13 Participants Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol.
Change in Independence With Daily Activities	51.7 change score on a scale Standard Deviation 21.0

SECONDARY outcome

Timeframe: Baseline to 6 months

Change in cognition measured with the Cognitive Linguistic Quick Test Executive Function Score. The severity score measures executive functions using 4 tasks (symbol trails, generative naming, mazes, and design generation). The score ranges from 40 (within normal limits) to 0 (severe impairment). Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5).

Outcome measures

Outcome measures
Measure	Strategy Training n=13 Participants Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol.
Change in Cognition	1.8 composite score Standard Deviation 3.5

Adverse Events

Strategy Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Skidmore

University of Pittsburgh

Phone: (412) 383-6617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place