| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Behavioral: BLAST | Not Applicable |
Stroke, which is the leading cause of disability, cognitive impairment and death in the US, imposes significant financial and personal burden. Although the residual effects of stroke affect many aspects of life, many aspects are not addressed by traditional rehabilitation treatments. In particular, persons with mild stroke, typically defined as a stroke with no or slight motor impairment and a high level of independence in basic activities of daily living, often experience emotional problems, subtle but significant cognitive impairment and decreased participation in productive, social and leisure activity. Despite these problems, persons with mild stroke are typically discharged to home without further referral to health or rehabilitation services other than follow-up with primary care physicians.
This application is in response to RFA PA-11-335 (Lab to Marketplace: Tools for Biomedical and Behavioral Research), a special 2-year Phase I SBIR program to accelerate the translation of behavioral research from academic to the marketplace. The project is based on the extensive research that developed and tested reliable and valid measures of activity participation (Activity Card Sort, or ACS) and cognitive skills supporting performance of simple and complex functional tasks (Functional Behavior Profile, or FBP). These measures have been used to guide treatments to help persons with mild cognitive impairment and their families support functional independence. These measures and the results of other studies will be used to build a dynamic online self-management tool designed to help persons with mild stroke develop individualized strategies that will support optimal recovery.
The investigators propose to evaluate the feasibility of Better Living After Stroke through Technology (BLAST) to help stroke survivors and family members return back to their productive and meaningful lives by proactively 1) helping them set their activity goals using ACS, 2) assessing their behavioral/functional capabilities using FBP, 3) recognizing symptoms indicative potential secondary stroke risks, 4) engaging support from online/community resources, and 5) offering tailored self-management recommendations using evidence-based strategies on how to achieve their activity goals and avoid secondary stroke based on their capabilities, stroke-related symptoms and available social resources.
Stroke survivors and family using the BLAST system are expected to have 1) better life satisfaction as measured by the Overall Recovery item of the Stroke Impact Scale; 2) increased activity as measured by Activity Card Sort; 3) better problem-solving and task performance as measured by Functional Behavior Profile; and 4) fewer caregiver concerns as measured by the Stroke Caregiver Needs Scale.
Specific Aims: 1) to evaluate the acceptability of BLAST ; and 2) to evaluate the preliminary effect of BLAST on self-efficacy, participation, and community reintegration.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 7 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Single group feasibility study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Feasibility of Better Living After Stroke Through Technology |
| Actual Study Start Date : | April 25, 2019 |
| Actual Primary Completion Date : | May 18, 2020 |
| Actual Study Completion Date : | May 18, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BLAST
All participants in this study will be assigned to this group to participate in the BLAST intervention. The intervention will be a self-guided web-based platform using a self-management model to help support better engagement in everyday life activity
|
Behavioral: BLAST
12-week self-guided intervention using a web-based platform
|
| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| United States, Missouri | |
| University of Missouri: Department of Occupational Therapy | |
| Columbia, Missouri, United States, 65211 | |
| Principal Investigator: | Timothy Wolf, OTD, PhD | University of Missouri-Columbia |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||
| First Posted Date ICMJE | May 2, 2019 | ||||
| Last Update Posted Date | April 14, 2021 | ||||
| Actual Study Start Date ICMJE | April 25, 2019 | ||||
| Actual Primary Completion Date | May 18, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Feasibility of Better Living After Stroke Through Technology | ||||
| Official Title ICMJE | Feasibility of Better Living After Stroke Through Technology | ||||
| Brief Summary | The investigators propose to evaluate the feasibility of Better Living After Stroke through Technology (BLAST) to help stroke survivors and family members return back to their productive and meaningful lives by proactively 1) helping them set their activity goals using ACS, 2) assessing their behavioral/functional capabilities using FBP, 3) recognizing symptoms indicative potential secondary stroke risks, 4) engaging support from online/community resources, and 5) offering tailored self-management recommendations using evidence-based strategies on how to achieve their activity goals and avoid secondary stroke based on their capabilities, stroke-related symptoms and available social resources. | ||||
| Detailed Description |
Stroke, which is the leading cause of disability, cognitive impairment and death in the US, imposes significant financial and personal burden. Although the residual effects of stroke affect many aspects of life, many aspects are not addressed by traditional rehabilitation treatments. In particular, persons with mild stroke, typically defined as a stroke with no or slight motor impairment and a high level of independence in basic activities of daily living, often experience emotional problems, subtle but significant cognitive impairment and decreased participation in productive, social and leisure activity. Despite these problems, persons with mild stroke are typically discharged to home without further referral to health or rehabilitation services other than follow-up with primary care physicians. This application is in response to RFA PA-11-335 (Lab to Marketplace: Tools for Biomedical and Behavioral Research), a special 2-year Phase I SBIR program to accelerate the translation of behavioral research from academic to the marketplace. The project is based on the extensive research that developed and tested reliable and valid measures of activity participation (Activity Card Sort, or ACS) and cognitive skills supporting performance of simple and complex functional tasks (Functional Behavior Profile, or FBP). These measures have been used to guide treatments to help persons with mild cognitive impairment and their families support functional independence. These measures and the results of other studies will be used to build a dynamic online self-management tool designed to help persons with mild stroke develop individualized strategies that will support optimal recovery. The investigators propose to evaluate the feasibility of Better Living After Stroke through Technology (BLAST) to help stroke survivors and family members return back to their productive and meaningful lives by proactively 1) helping them set their activity goals using ACS, 2) assessing their behavioral/functional capabilities using FBP, 3) recognizing symptoms indicative potential secondary stroke risks, 4) engaging support from online/community resources, and 5) offering tailored self-management recommendations using evidence-based strategies on how to achieve their activity goals and avoid secondary stroke based on their capabilities, stroke-related symptoms and available social resources. Stroke survivors and family using the BLAST system are expected to have 1) better life satisfaction as measured by the Overall Recovery item of the Stroke Impact Scale; 2) increased activity as measured by Activity Card Sort; 3) better problem-solving and task performance as measured by Functional Behavior Profile; and 4) fewer caregiver concerns as measured by the Stroke Caregiver Needs Scale. Specific Aims: 1) to evaluate the acceptability of BLAST ; and 2) to evaluate the preliminary effect of BLAST on self-efficacy, participation, and community reintegration. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single group feasibility study Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||
| Intervention ICMJE | Behavioral: BLAST
12-week self-guided intervention using a web-based platform
|
||||
| Study Arms ICMJE | Experimental: BLAST
All participants in this study will be assigned to this group to participate in the BLAST intervention. The intervention will be a self-guided web-based platform using a self-management model to help support better engagement in everyday life activity
Intervention: Behavioral: BLAST
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Actual Enrollment ICMJE |
7 | ||||
| Original Estimated Enrollment ICMJE |
40 | ||||
| Actual Study Completion Date ICMJE | May 18, 2020 | ||||
| Actual Primary Completion Date | May 18, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 55 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03935789 | ||||
| Other Study ID Numbers ICMJE | 2013982 R44NR016183 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Timothy J Wolf, University of Missouri-Columbia | ||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Missouri-Columbia | ||||
| Verification Date | April 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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