Stroke, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Brief summary
Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time. The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention. Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.
Interventions
BEHAVIORALteleABLE
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stroke diagnosis ≤12 months prior to study enrollment * ≥6 hours of sedentary behavior on a typical weekday (assessed by Sedentary Behavior Questionnaire) * Ambulatory with or without assistive device (assessed by Functional Independence Measure, mobility score ≥5) * Able to access an electronic device (smartphone, tablet, or computer) that is compatible with a videoconferencing application * Able to identify a support person with whom the participant has face-to-face interaction at least one time per week * Able and willing to participate fully in the study and provide informed consent
Exclusion criteria
* Currently receiving care in an inpatient rehabilitation, transitional care unit, or skilled nursing facility * Severe cognitive or communication impairments (inability to respond accurately to complete study telephone screening or complete informed consent) * Comorbid neurodegenerative disorder (e.g. Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma) * Comorbid cancer, currently undergoing chemotherapy or radiation treatment * Comorbid major depressive disorder (assessed by Patient Health Questionnaire-2, score ≥2) * Received inpatient treatment or hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months * Diagnosis of a terminal illness and/or in hospice care * History of skin sensitivity that precludes the use of medical tape necessary for adherence to activity monitor measure * Inability to speak, read, or understand English * Concurrent participation in another rehabilitation intervention research study * Investigator discretion for safety or adherence reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 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. |
| Participant Satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participation Restrictions | 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. |
| Change in Health-Related Quality of Life | 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. |
| Change in Sedentary Minutes | week 0 to week 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | teleABLE |
|---|---|
| Age, Continuous | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Incidence of Treatment-Emergent Adverse Events
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.
Time frame: week 2 through week 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| teleABLE | Incidence of Treatment-Emergent Adverse Events | Non-serious (e.g., muscle soreness, skin irritation) | 2 adverse events |
| teleABLE | Incidence of Treatment-Emergent Adverse Events | Serious (e.g., injurious fall) | 0 adverse events |
Primary
Participant Satisfaction
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.
Time frame: week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| teleABLE | Participant Satisfaction | 3.7 score on a scale of 1 to 4 | Standard Deviation 0.3 |
Secondary
Change in Health-Related Quality of Life
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.
Time frame: week 0 to week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| teleABLE | Change in Health-Related Quality of Life | 0.06 change score on a scale of -1 to 1 |
Secondary
Change in Participation Restrictions
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.
Time frame: week 0 to week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| teleABLE | Change in Participation Restrictions | 9.5 change in % retained activities |
Secondary
Change in Sedentary Minutes
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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| teleABLE | Change in Sedentary Minutes | 32.2 change in sedentary minutes |