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

Primary Purpose

Medication Adherence, Heart Failure, Aging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SystemCHANGE
Sponsored by
University of Missouri, Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Medication Adherence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Belleville Memorial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SystemCHANGE intervention

Attention Control

Arm Description

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.

The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures.

Outcomes

Primary Outcome Measures

Acceptability and feasibility using open ended questionnaire
open ended questionnaire asking participants about acceptability and feasibility

Secondary Outcome Measures

Systems thinking using questionnaire
questionnaire asking about personal systems behavior perceptions
Kansas City Cardiomyopathy Questionnaire
heart failure outcomes - SOB, fatigue, swelling, activity tolerance
Medication adherence using medication event monitoring systems
Medication event monitoring systems

Full Information

First Posted
May 11, 2017
Last Updated
May 24, 2019
Sponsor
University of Missouri, Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT03162848
Brief Title
SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure
Acronym
ECHO
Official Title
Impact of SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Pilot RCT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Heart Failure, Aging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SystemCHANGE intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures.
Intervention Type
Behavioral
Intervention Name(s)
SystemCHANGE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability and feasibility using open ended questionnaire
Description
open ended questionnaire asking participants about acceptability and feasibility
Time Frame
one point in time at the end of the maintenance phase which is 3 months after randomization into groups
Secondary Outcome Measure Information:
Title
Systems thinking using questionnaire
Description
questionnaire asking about personal systems behavior perceptions
Time Frame
baseline and after 2 month intervention phase
Title
Kansas City Cardiomyopathy Questionnaire
Description
heart failure outcomes - SOB, fatigue, swelling, activity tolerance
Time Frame
baseline and after 2 month intervention phase
Title
Medication adherence using medication event monitoring systems
Description
Medication event monitoring systems
Time Frame
after randomization through end of maintenance phase for a total of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Andrews, PhD(c)
Organizational Affiliation
University of Missouri, Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belleville Memorial
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62225
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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