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Completed

NCT Number: NCT03211130

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

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Jennifer Wessol

Parkville, Missouri, 64152, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. 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).

  2. 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.

  3. 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.

  4. Medication Adherence

    Time frame: 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.).

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Collaborators

  • Saint Luke's Health System

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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