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Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211130
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Saint Luke's Health System
Information provided by (Responsible Party):
Cynthia Russell, University of Missouri, Kansas City

Brief Summary:
This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Behavioral: SystemCHANGE™ Behavioral: Attention-Control Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : February 6, 2018
Actual Study Completion Date : May 24, 2018

Arm Intervention/treatment
Experimental: SystemCHANGE™ Behavioral: 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.

Active Comparator: Attention-Control Behavioral: 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.




Primary Outcome Measures :
  1. Acceptability and feasibility [ Time Frame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups ]
    Open ended questionnaire


Secondary Outcome Measures :
  1. Social Support [ Time Frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase. ]
    The Social Support Appraisals Index (SS-A) is a 23-item self-administered, a self-report scale measuring the degree to which a person feels cared for, respected, and involved with family and friends. The scale had good reliability and validity (Cronbach α coefficients .90, .81, and .84) (Vaux et al., 1986).

  2. Perceived Health [ Time Frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase. ]
    Perceived health status will be measured by one question, "How is your health in general?" Participant select excellent, very good, good, fair, poor, or very poor. Perceived health status reflects people's overall perception of their health, including both physical and psychological dimensions.

  3. Personal Systems Behaviors [ Time Frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase. ]
    The Systems Thinking Survey (adapted for patients), a 20-item, 5-point Likert response scale measuring perceptions of personal system behaviors.

  4. Medication Adherence [ Time Frame: after randomization through end of maintenance phase for a total of 3 months ]
    MA data will be retrieved from the MEMS®cap which is a medication cap containing a battery and microelectronics that records the date and the time of each cap removal to create a medication "event" ("MEMS® Cap versatile adherence monitoring cap," n.d.).



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age ≥50 years old
  • 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:

-


Information from the National Library of Medicine

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): NCT03211130


Locations
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United States, Missouri
Jennifer Wessol
Parkville, Missouri, United States, 64152
Sponsors and Collaborators
University of Missouri, Kansas City
Saint Luke's Health System
Investigators
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Principal Investigator: Jennifer L. Wessol, BSN University of Missouri, Kansas City
Study Chair: Cynthia L. Russell, Ph.D. Professor
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Responsible Party: Cynthia Russell, Professor, School of Nursing, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT03211130    
Other Study ID Numbers: Dissertation
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cynthia Russell, University of Missouri, Kansas City:
medication adherence
self-management
antithrombotic
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases