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Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth (teleABLE)

Primary Purpose

Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
teleABLE
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First-ever stroke diagnosis ≤12 months prior to study enrollment
  • Discharged directly from the acute medical setting to homecare or selfcare setting following stroke
  • ≥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:

  • 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
  • Planning to move away from the Chicagoland area prior to the anticipated end of study participation
  • Concurrent participation in another rehabilitation intervention research study
  • Investigator discretion for safety or adherence reasons

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

teleABLE

Arm Description

Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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 -0.573 to 1), with high scores indicating high quality of life.
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.

Full Information

First Posted
July 30, 2021
Last Updated
October 20, 2023
Sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05029284
Brief Title
Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth
Acronym
teleABLE
Official Title
teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke Hemorrhagic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
teleABLE
Arm Type
Experimental
Arm Description
Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook.
Intervention Type
Behavioral
Intervention Name(s)
teleABLE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
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
Title
Participant Satisfaction
Description
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
Secondary Outcome Measure Information:
Title
Change in Participation Restrictions
Description
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
Title
Change in Health-Related Quality of Life
Description
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 -0.573 to 1), with high scores indicating high quality of life.
Time Frame
week 0 to week 8
Title
Change in Sedentary Minutes
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karli Jahnke, MOT, OTR/L
Phone
612-626-4046
Email
dwell@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Kringle, PhD, OTR/L
Phone
612-624-8994
Email
ekringle@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Kringle, PhD, OTR/L
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karli Jahnke, MOT, OTR/L
Phone
612-626-4046
Email
dwell@umn.edu
First Name & Middle Initial & Last Name & Degree
Emily Kringle, PhD, OTR/L
Phone
612-624-8994
Email
ekringle@umn.edu

12. IPD Sharing Statement

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Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth

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