Impact of SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Pilot RCT

University of Missouri, Kansas City1 site in 1 country2 target enrollmentSeptember 1, 2017

ConditionsMedication Adherence Heart Failure Aging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Medication Adherence
Sponsor: University of Missouri, Kansas City
Enrollment: 2
Locations: 1
Primary Endpoint: Acceptability and feasibility using open ended questionnaire
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. The intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.

Registry

clinicaltrials.gov

Start Date

September 1, 2017

End Date

April 30, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Missouri, Kansas City

Responsible Party

Principal Investigator

Angela Andrews

PhD Student

University of Missouri, Kansas City

Eligibility Criteria

Inclusion Criteria

•age 50 years or older
•HF diagnosis confirmed by their physician utilizing their most recent ejection fraction
•prescribed diuretics
•self-administering medications
•able to open an electronic cap
•able to speak, hear and understand English
•not hospitalized,
•no cognitive impairment as determined by a score of 4 or greater on the 6-item mini-mental status exam.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Acceptability and feasibility using open ended questionnaire

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

open ended questionnaire asking participants about acceptability and feasibility

Secondary Outcomes

Systems thinking using questionnaire(baseline and after 2 month intervention phase)
Kansas City Cardiomyopathy Questionnaire(baseline and after 2 month intervention phase)
Medication adherence using medication event monitoring systems(after randomization through end of maintenance phase for a total of 3 months)