Clinical trial NCT05029284: Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth
Official title: teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: week 2 through week 7
measure: Participant Satisfaction
timeFrame: week 8
Secondary outcomes:
measure: Change in Participation Restrictions
timeFrame: week 0 to week 8
measure: Change in Health-Related Quality of Life
timeFrame: week 0 to week 8
measure: Change in Sedentary Minutes
timeFrame: week 0 to week 8
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Emily Kringle, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: