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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Behavioral: SystemCHANGE™
* Behavioral: Attention-Control


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SystemCHANGE™<br> | Behavioral: SystemCHANGE™<br>* 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.<br>|
| Active Comparator: Attention-Control<br> | Behavioral: Attention-Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and feasibility | Open ended questionnaire | one point in time at the end of the maintenance phase which is 3 months after randomization into groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase. | 
| 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. | One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase. | 
| Personal Systems Behaviors | The Systems Thinking Survey (adapted for patients), a 20-item, 5-point Likert response scale measuring perceptions of personal system behaviors. | One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase. | 
| 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.). | after randomization through end of maintenance phase for a total of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication adherence, self-management, antithrombotic