Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
|ClinicalTrials.gov Identifier: NCT03211130|
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Ischemic||Behavioral: SystemCHANGE™ Behavioral: Attention-Control||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
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||
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.
- 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
- 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).
- 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.
- 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.
- 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.).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211130
|United States, Missouri|
|Parkville, Missouri, United States, 64152|
|Principal Investigator:||Jennifer L. Wessol, BSN||University of Missouri, Kansas City|
|Study Chair:||Cynthia L. Russell, Ph.D.||Professor|