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Clinical Trials/NCT03211130
NCT03211130CompletedPhase 1

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

University of Missouri, Kansas City1 site in 1 country30 target enrollmentStarted: November 28, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Acceptability and feasibility
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

SystemCHANGE™

Experimental

Intervention: SystemCHANGE™ (Behavioral)

Attention-Control

Active Comparator

Intervention: Attention-Control (Behavioral)

Outcomes

Primary Outcomes

Acceptability and feasibility

Time Frame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups

Open ended questionnaire

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cynthia Russell

Professor, School of Nursing

University of Missouri, Kansas City

Study Sites (1)

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