Trial Outcomes & Findings for Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth (NCT NCT05029284)

NCT ID: NCT05029284

Last Updated: 2025-06-29

Results Overview

The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: week 2 through week 7
• Results posted on: 2025-06-29

Participant Flow

Participant milestones

Measure	teleABLE Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

teleABLE Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.

Overall Study Lost to Follow-up

1

Baseline Characteristics

Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth

Baseline characteristics by cohort

Measure	teleABLE n=11 Participants Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: week 2 through week 7

The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported.

Outcome measures

Measure	teleABLE n=11 Participants Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.
Incidence of Treatment-Emergent Adverse Events Non-serious (e.g., muscle soreness, skin irritation)	2 adverse events
Incidence of Treatment-Emergent Adverse Events Serious (e.g., injurious fall)	0 adverse events

PRIMARY outcome

Timeframe: week 8

Assessed by the Client Satisfaction Questionnaire-8. This is an 8-item questionnaire with each item ranked on an 1 to 4 Likert-type scale. We will compute the mean score across all items. The possible range is 1 to 4, with high scores indicating high satisfaction.

Outcome measures

Measure

teleABLE n=10 Participants Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.

Participant Satisfaction

3.7 score on a scale of 1 to 4 Standard Deviation 0.3

SECONDARY outcome

Timeframe: week 0 to week 8

Assessed by the Activity Card Sort 3. This is a 100-item tool during which participants indicate whether they did the activity prior to their stroke, continue to do the activity since their stroke, or have given up the activity since their stroke. Change in the proportion of activities retained will be reported.

Outcome measures

Measure

teleABLE n=10 Participants Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.

Change in Participation Restrictions

9.5 change in % retained activities Interval -1.5 to 20.5

SECONDARY outcome

Timeframe: week 0 to week 8

Assessed by the EuroQol-5 Dimension-5 Level. This is a 5-item self-report questionnaire with each item scored on a 1 to 5 scale. Scores are converted to Index Scores following published procedures (possible range -1 to 1), with high scores indicating high quality of life.

Outcome measures

Measure

teleABLE n=10 Participants Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.

Change in Health-Related Quality of Life

0.06 change score on a scale of -1 to 1 Interval -0.01 to 0.11

SECONDARY outcome

Timeframe: week 0 to week 8

Population: n=1 participant lost to follow-up n=3 participants with \<6 valid activPAL days at 1 or more timepoints

Assessed using the activPAL micro3 monitor following a 7-day wear protocol. The mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be computed for each time point. Change in mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be reported.

Outcome measures

Measure

teleABLE n=7 Participants Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.

Change in Sedentary Minutes

32.2 change in sedentary minutes Interval -14.3 to 49.8

Adverse Events

teleABLE

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	teleABLE n=10 participants at risk Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.
Musculoskeletal and connective tissue disorders Muscle soreness	10.0% 1/10 • Number of events 1 • 8 weeks Adverse events were queried using a questionnaire at the Week 8 assessment timepoint. If the treating occupational therapist became aware of an adverse event during an intervention session, it was reported at the time it was discovered.
Skin and subcutaneous tissue disorders Skin irritation	10.0% 1/10 • Number of events 1 • 8 weeks Adverse events were queried using a questionnaire at the Week 8 assessment timepoint. If the treating occupational therapist became aware of an adverse event during an intervention session, it was reported at the time it was discovered.

Additional Information

Dr. Emily Kringle

University of Minnesota

Phone: (612) 624-8994

Email: ekringle@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place