duoABLE for People With Stroke and Their Caregivers
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05964400 |
Recruitment Status :
Recruiting
First Posted : July 27, 2023
Last Update Posted : October 10, 2023
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Condition or disease | Intervention/treatment | Phase |
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Stroke Stroke Ischemic Stroke Hemorrhagic Stroke Sequelae | Behavioral: duoABLE | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | duoABLE for People With Stroke and Their Caregivers (Feasibility) |
Actual Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | May 1, 2024 |
Estimated Study Completion Date : | May 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: duoABLE
Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels
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Behavioral: duoABLE
Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels |
- Participant satisfaction [ Time Frame: Score at week 8 ]Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)
- Change in activity restrictions [ Time Frame: Baseline to 8 weeks ]Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3
- Change in sedentary minutes per day [ Time Frame: Baseline to 8 weeks ]Minutes of sedentary time per day, measured using the activPAL micro4 (mean minutes per day determined by 7-day wear protocol) at baseline and week 8.
- Change in daily step count [ Time Frame: Baseline to 8 weeks ]Count of steps per day, measured using the activPAL micro4 (mean daily step count determined by 7-day wear protocol) at baseline and week 8.
- Change in Health-related quality of life [ Time Frame: Baseline to 8 weeks ]Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8
- Adverse event count [ Time Frame: Count of adverse events at week 8 ]Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Stroke Participants):
- Stroke diagnosed more than 6 months ago
- Are 18 years of age or older
- Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
- Reside in a community-based setting
- Are mobile within their home, with or without an assistive device and without physical assistance
- Are able to identify an eligible caregiver who will engage in assessments and intervention.
Inclusion Criteria (Caregiver Participants):
- Are 18 years of age or older
- Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
- Reside in a community-based setting
- Are mobile within their home, with or without an assistive device and without physical assistance
Exclusion Criteria (Stroke Participants):
- Severe aphasia
- Are currently receiving chemotherapy or radiation treatments for cancer
- Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
- Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
- Have a history of skin sensitivity related to adhesives
- Are pregnant or expecting to become pregnant in the next 2 months
- Reside in an institutional setting
- Are currently incarcerated
Exclusion Criteria (Caregiver Participants):
- Have a history of skin sensitivity related to adhesives
- Are currently receiving chemotherapy or radiation treatments for cancer
- Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
- Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
- Are pregnant or expecting to become pregnant in the next 2 months
- Reside in an institutional setting
- Are currently incarcerated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964400
Contact: Karli Jahnke, MOT, OTR/L | (612) 626-4046 | dwell@umn.edu |
United States, Minnesota | |
School of Kinesiology, University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Karli Jahnke, MOT, OTR/L 612-626-4046 dwell@umn.edu |
Principal Investigator: | Emily A Kringle, PhD, OTR/L | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT05964400 |
Other Study ID Numbers: |
duoABLE AOTFIRG23KRINGLE ( Other Grant/Funding Number: American Occupational Therapy Foundation ) |
First Posted: | July 27, 2023 Key Record Dates |
Last Update Posted: | October 10, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | There are no current plans to share data with other investigators. Upon the completion of the study, a de-identified dataset that includes questionnaire data, raw and processed activPAL data, and transcribed interview data will be created and stored in the DWELL Laboratory at the University of Minnesota. The PI will consider individual requests for data sharing and provide only the necessary de-identified data upon reasonable request, under a University of Minnesota data use agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
lifestyle physical activity duoABLE ABLE rehabilitation |
rehab occupational therapy physical therapy stroke |
Stroke Hemorrhagic Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |