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

Not Applicable

Completed

• Conditions: Aging; Heart Failure; Medication Adherence
• Interventions: Behavioral: SystemCHANGE

• Registration Number: NCT03162848
• Lead Sponsor: University of Missouri, Kansas City

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Study Start: 2017-09-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SystemCHANGE intervention	SystemCHANGE	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.

Primary Outcome Measures

Name	Time	Method
Acceptability and feasibility using open ended questionnaire	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 Outcome Measures

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

Trial Locations

Locations (1)

Belleville Memorial; 🇺🇸 Belleville, Illinois, United States