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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211130
• Other study ID #: Dissertation
• Status: Completed
• Phase: Early Phase 1
• Start date: November 28, 2017
• Est. completion date: May 24, 2018

Study information

• Verified date: August 2019
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 24, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Stroke
• Stroke, Ischemic

Intervention

Behavioral:
• SystemCHANGE™
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.
• 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.

Locations

Country	Name	City	State
United States	Jennifer Wessol	Parkville	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, Kansas City	Saint Luke's Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 a coefficients .90, .81, and .84) (Vaux et al., 1986).	One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Secondary	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.
Secondary	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.
Secondary	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