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

NCT03211130 | Completed Early Phase 1 DMC

• 1 other identifier: Dissertation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

medication adherence; self-management; antithrombotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Social Support

  One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.

• Perceived Health

  One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.

• Personal Systems Behaviors

  One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.

• Medication Adherence

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

Study Arms (2)

SystemCHANGE™

EXPERIMENTAL

Behavioral: SystemCHANGE™

Attention-Control

ACTIVE COMPARATOR

Behavioral: Attention-Control

Interventions

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.

SystemCHANGE™

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.

Attention-Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• Saint Luke's Health System: collaborator

Study Sites (1)

Jennifer Wessol

Parkville, Missouri, 64152, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Medication Adherence

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jennifer L. Wessol, BSN

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

• Cynthia L. Russell, Ph.D.

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: November 28, 2017
• Primary Completion: February 6, 2018
• Study Completion: May 24, 2018
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

US (1)