SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure (ECHO)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Medication Adherence; Aging
• Intervention / Treatment: Behavioral: SystemCHANGE

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Belleville, Illinois, United States, 62225
      • Belleville Memorial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SystemCHANGE intervention; The SystemCHANGE™ intervention utilizes the Socioecological Model and Plan-Do-Check Act model as its framework and focuses on changing the individual's environment to change behavior using small experiments with feedback.	Behavioral: SystemCHANGE; At initial home visit, the PI will work with the participant to identify important people for medication taking, routines, and cycles of routines. Possible solutions to incorporate medication taking into routines will be identified by the participant and PI and the participant will start implementing these solutions. Medication adherence will continuously be monitored using medication event monitoring systems. At one month, the participant will be sent a report on medication taking and a phone call will occur with the PI to discuss if solutions improved medication adherence or if other solutions need to be implemented. At month two, the intervention will end but participants are urged to continue to use solutions long term.
No Intervention: Attention Control; The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and feasibility using open ended questionnaire	open ended questionnaire asking participants about acceptability and feasibility	one point in time at the end of the maintenance phase which is 3 months after randomization into groups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systems thinking using questionnaire	questionnaire asking about personal systems behavior perceptions	baseline and after 2 month intervention phase
Kansas City Cardiomyopathy Questionnaire	heart failure outcomes - SOB, fatigue, swelling, activity tolerance	baseline and after 2 month intervention phase
Medication adherence using medication event monitoring systems	Medication event monitoring systems	after randomization through end of maintenance phase for a total of 3 months

Collaborators and Investigators

• Sponsor: University of Missouri, Kansas City
• Investigators: Principal Investigator: Angela Andrews, PhD(c), University of Missouri, Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 17-130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No