Trial Outcomes & Findings for Activating Behavior for Lasting Engagement After Stroke (NCT NCT03305731)
NCT ID: NCT03305731
Last Updated: 2020-02-19
Results Overview
Objectively measured sedentary time (ActivPAL)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Results posted on
2020-02-19
Participant Flow
Participant milestones
| Measure |
Activating Behavior for Lasting Engagement
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
Week 6
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20
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Overall Study
Week 11
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Activating Behavior for Lasting Engagement
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Overall Study
Protocol Violation
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1
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Baseline Characteristics
Non-compliance with activity monitor, n=1
Baseline characteristics by cohort
| Measure |
Activating Behavior for Lasting Engagement
n=21 Participants
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Age, Continuous
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70.81 years
STANDARD_DEVIATION 10.92 • n=21 Participants
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Sex: Female, Male
Female
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13 Participants
n=21 Participants
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Sex: Female, Male
Male
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8 Participants
n=21 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=21 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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21 Participants
n=21 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=21 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=21 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=21 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=21 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=21 Participants
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Race (NIH/OMB)
White
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17 Participants
n=21 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=21 Participants
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Region of Enrollment
United States
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21 participants
n=21 Participants
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Stroke Chronicity
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29.38 months
STANDARD_DEVIATION 14.34 • n=21 Participants
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Stroke Type
Ischemic
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19 Participants
n=21 Participants
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Stroke Type
Hemorrhagic
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2 Participants
n=21 Participants
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Stroke Hemisphere
Left Hemisphere
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12 Participants
n=21 Participants
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Stroke Hemisphere
Right Hemisphere
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7 Participants
n=21 Participants
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Stroke Hemisphere
Both Hemispheres
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2 Participants
n=21 Participants
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Prolonged Sitting
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466.56 minutes
STANDARD_DEVIATION 168.65 • n=20 Participants • Non-compliance with activity monitor, n=1
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PRIMARY outcome
Timeframe: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeksObjectively measured sedentary time (ActivPAL)
Outcome measures
| Measure |
Activating Behavior for Lasting Engagement
n=20 Participants
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
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54.95 minutes
Standard Deviation 81.10
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PRIMARY outcome
Timeframe: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeksObjectively measured sedentary breaks (ActivPAL)
Outcome measures
| Measure |
Activating Behavior for Lasting Engagement
n=20 Participants
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Change in Daily Number of Sedentary Breaks
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2.61 breaks
Standard Deviation 4.59
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SECONDARY outcome
Timeframe: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeksObjectively measured sedentary breaks (ActivPAL)
Outcome measures
| Measure |
Activating Behavior for Lasting Engagement
n=20 Participants
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Change in Daily Number of Sedentary Breaks
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-2.55 breaks
Standard Deviation 5.90
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SECONDARY outcome
Timeframe: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeksObjectively measured sedentary time (ActivPAL)
Outcome measures
| Measure |
Activating Behavior for Lasting Engagement
n=20 Participants
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
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14.08 minutes
Standard Deviation 58.95
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SECONDARY outcome
Timeframe: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeksClient rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.
Outcome measures
| Measure |
Activating Behavior for Lasting Engagement
n=20 Participants
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Change in Participation
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1.48 score on a scale
Standard Deviation 8.52
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SECONDARY outcome
Timeframe: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeksClient rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.
Outcome measures
| Measure |
Activating Behavior for Lasting Engagement
n=20 Participants
Participants will engage in the ABLE intervention.
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
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|---|---|
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Change in Participation
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1.33 score on a scale
Standard Deviation 15.38
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Adverse Events
Activating Behavior for Lasting Engagement
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place