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

NCT03211130 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-21

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Saint Luke's Health System

    collaborator OTHER

  • University of Missouri, Kansas City

    lead OTHER

Principal Investigators

  • Jennifer L. Wessol, BSN · University of Missouri, Kansas City

  • Cynthia L. Russell, Ph.D. · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2018-02-06
Completion
2018-05-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03211130 on ClinicalTrials.gov