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| Name | Class |
|---|---|
| Saint Luke's Health System | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SystemCHANGE™ | Experimental |
| |
| Attention-Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SystemCHANGE™ | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L. Wessol, BSN | University of Missouri, Kansas City | Principal Investigator |
| Cynthia L. Russell, Ph.D. | Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jennifer Wessol | Parkville | Missouri | 64152 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Attention-Control | Behavioral | 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. |
|
| 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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |