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

Early Phase 1

Completed

• Conditions: Stroke, Ischemic
• Interventions: Behavioral: SystemCHANGE™; Behavioral: Attention-Control

• Registration Number: NCT03211130
• Lead Sponsor: University of Missouri, Kansas City

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Study Start: 2017-11-28
• Primary Completion: 2018-02-06
• Study Completion: 2018-05-24
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SystemCHANGE™	SystemCHANGE™	-
Attention-Control	Attention-Control	-

Primary Outcome Measures

Name	Time	Method
Acceptability and feasibility	one point in time at the end of the maintenance phase which is 3 months after randomization into groups	Open ended questionnaire

Secondary Outcome Measures

Name	Time	Method
Social Support	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	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	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	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.).

Trial Locations

Locations (1)

Jennifer Wessol; 🇺🇸 Parkville, Missouri, United States