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

Browse trials for

• Stroke 7,286
• Ischemic Stroke 2,593

Keywords

• medication adherence
• self-management
• antithrombotic

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Lead sponsor

University of Missouri, Kansas City is the lead sponsor of 47 studies on the registry; 9 are open to participants now.

Study arms

• Experimental
  SystemCHANGE™

  Behavioral: SystemCHANGE™

• Active comparator
  Attention-Control

  Behavioral: Attention-Control

Interventions

• BehavioralSystemCHANGE™

  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.

• BehavioralAttention-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 outcomes

1. Acceptability and feasibility

   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 outcomes

1. 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).

   Time frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.

2. 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.

   Time frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.

3. Personal Systems Behaviors

   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.

4. 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.).

   Time frame: after randomization through end of maintenance phase for a total of 3 months

Individual participant data

Plan to share: Undecided