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

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified July 2017 by University of Missouri, Kansas City

Sponsor:

Collaborator:

Saint Luke's Health System

Information provided by (Responsible Party):

University of Missouri, Kansas City

ClinicalTrials.gov Identifier:

NCT03211130

First received: July 5, 2017

Last updated: July 6, 2017

Last verified: July 2017

History of Changes

Purpose

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.

Condition	Intervention	Phase
Stroke, Ischemic	Behavioral: SystemCHANGE™ Behavioral: Attention-Control	Early Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant Primary Purpose: Prevention
Official Title:	Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors

Further study details as provided by University of Missouri, Kansas City:

Primary Outcome Measures:

Medication Adherence [ Time Frame: 5 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.).

Secondary Outcome Measures:

Social Support [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment:	30
Anticipated Study Start Date:	October 2017
Estimated Study Completion Date:	March 2018
Estimated Primary Completion Date:	January 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SystemCHANGE™	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.
Active Comparator: Attention-Control	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.

Arms

Assigned Interventions

Experimental: SystemCHANGE™

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.

Active Comparator: Attention-Control

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.

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age ≥65years 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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211130

Contacts


Contact: Jennifer L. Wessol, BSN	913-522-9757	jwvx8@mail.umkc.edu

Sponsors and Collaborators

University of Missouri, Kansas City

Saint Luke's Health System

Investigators


Principal Investigator:	Jennifer L. Wessol, BSN	University of Missouri, Kansas City
Study Chair:	Cynthia L. Russell, Ph.D.	Professor

More Information


Responsible Party:	University of Missouri, Kansas City
ClinicalTrials.gov Identifier:	NCT03211130 History of Changes
Other Study ID Numbers:	Dissertation
Study First Received:	July 5, 2017
Last Updated:	July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by University of Missouri, Kansas City:


medication adherence self-management antithrombotic

Additional relevant MeSH terms:


Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 11, 2017

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