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

Heart Failure Clinical Trial

— ECHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162848
• Other study ID #: 17-130
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2019
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Heart Failure
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	Belleville Memorial	Belleville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

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