Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
NCT ID: NCT03211130
Last Updated: 2019-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
30 participants
INTERVENTIONAL
2017-11-28
2018-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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SystemCHANGE™
SystemCHANGE™
During the intervention phase, the PI will visit both groups of participants at home at baseline and telephone them three times (day 3 ±2 days and months 1 and 2). Refer to tables 1 and 2 for intervention details. Treatment participants will implement SystemCHANGE™ activities related to medication taking with the assistance of the PI while attention-control participants will receive patient education materials on stroke. Perceived health data will be collected during the intervention phase. A 1-month maintenance phase follows the intervention phase. Electronic medication monitoring continues, but no intervention is delivered to either group.
Attention-Control
Attention-Control
An experienced stroke nurse will deliver the attention control intervention. Table 3.2 shows the 2-month attention-control intervention. The stroke materials were developed by the Saint Luke's Marion Bloch Neuroscience Institute and are given to every stroke patient prior to dismissal. The PI will call participants at day 3 ±2 days, and months 1 and 2 to review chapter(s) from the book and answer questions about it. Interval, frequency, and setting are all exactly the same for the intervention and control groups. If the control participant raises questions about medications or medication-taking, PI will refer them to their Neurologist.
Interventions
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SystemCHANGE™
During the intervention phase, the PI will visit both groups of participants at home at baseline and telephone them three times (day 3 ±2 days and months 1 and 2). Refer to tables 1 and 2 for intervention details. Treatment participants will implement SystemCHANGE™ activities related to medication taking with the assistance of the PI while attention-control participants will receive patient education materials on stroke. Perceived health data will be collected during the intervention phase. A 1-month maintenance phase follows the intervention phase. Electronic medication monitoring continues, but no intervention is delivered to either group.
Attention-Control
An experienced stroke nurse will deliver the attention control intervention. Table 3.2 shows the 2-month attention-control intervention. The stroke materials were developed by the Saint Luke's Marion Bloch Neuroscience Institute and are given to every stroke patient prior to dismissal. The PI will call participants at day 3 ±2 days, and months 1 and 2 to review chapter(s) from the book and answer questions about it. Interval, frequency, and setting are all exactly the same for the intervention and control groups. If the control participant raises questions about medications or medication-taking, PI will refer them to their Neurologist.
Eligibility Criteria
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Inclusion Criteria
* receives post-stroke care with Saint Luke's Neurological Consultants
* prescribed at least 1, once a day, antithrombotic medication
* able to provide informed consent
* able to open an electronic cap
* able to self-administer medications
* has or has access to a telephone
* has no cognitive impairment as determined by a score of 4 or greater on The Six- item Screener (SIS).
Exclusion Criteria
50 Years
ALL
Yes
Sponsors
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Saint Luke's Health System
OTHER
University of Missouri, Kansas City
OTHER
Responsible Party
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Cynthia Russell
Professor, School of Nursing
Principal Investigators
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Jennifer L. Wessol, BSN
Role: PRINCIPAL_INVESTIGATOR
University of Missouri, Kansas City
Cynthia L. Russell, Ph.D.
Role: STUDY_CHAIR
Professor
Locations
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Jennifer Wessol
Parkville, Missouri, United States
Countries
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Other Identifiers
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Dissertation
Identifier Type: -
Identifier Source: org_study_id
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