Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
Primary Purpose
Stroke, Ischemic
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
SystemCHANGE™
Attention-Control
Sponsored by
About this trial
This is an interventional prevention trial for Stroke, Ischemic focused on measuring medication adherence, self-management, antithrombotic
Eligibility 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:
-
Sites / Locations
- Jennifer Wessol
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SystemCHANGE™
Attention-Control
Arm Description
Outcomes
Primary Outcome Measures
Acceptability and feasibility
Open ended questionnaire
Secondary Outcome Measures
Social Support
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).
Perceived Health
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.
Personal Systems Behaviors
The Systems Thinking Survey (adapted for patients), a 20-item, 5-point Likert response scale measuring perceptions of personal system behaviors.
Medication Adherence
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.).
Full Information
NCT ID
NCT03211130
First Posted
July 5, 2017
Last Updated
August 19, 2019
Sponsor
University of Missouri, Kansas City
Collaborators
Saint Luke's Health System
1. Study Identification
Unique Protocol Identification Number
NCT03211130
Brief Title
Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
Official Title
Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City
Collaborators
Saint Luke's Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
medication adherence, self-management, antithrombotic
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SystemCHANGE™
Arm Type
Experimental
Arm Title
Attention-Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
SystemCHANGE™
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention-Control
Intervention Description
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 Measure Information:
Title
Acceptability and feasibility
Description
Open ended questionnaire
Time Frame
one point in time at the end of the maintenance phase which is 3 months after randomization into groups
Secondary Outcome Measure Information:
Title
Social Support
Description
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).
Time Frame
One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Title
Perceived Health
Description
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.
Time Frame
One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Title
Personal Systems Behaviors
Description
The Systems Thinking Survey (adapted for patients), a 20-item, 5-point Likert response scale measuring perceptions of personal system behaviors.
Time Frame
One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Title
Medication Adherence
Description
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.).
Time Frame
after randomization through end of maintenance phase for a total of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L. Wessol, BSN
Organizational Affiliation
University of Missouri, Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia L. Russell, Ph.D.
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Jennifer Wessol
City
Parkville
State/Province
Missouri
ZIP/Postal Code
64152
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
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