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Completed

NCT Number: NCT03162848

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

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.

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Key information

Conditions

Medication Adherence Aging Behavior Cardiovascular Diseases Health Behavior Heart Diseases Heart Failure Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belleville Memorial

Belleville, Illinois, 62225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SystemCHANGE

Behavioral

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 outcomes

  1. 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

  1. Systems thinking using questionnaire

    Time frame: baseline and after 2 month intervention phase

    questionnaire asking about personal systems behavior perceptions

  2. Kansas City Cardiomyopathy Questionnaire

    Time frame: baseline and after 2 month intervention phase

    heart failure outcomes - SOB, fatigue, swelling, activity tolerance

  3. Medication adherence using medication event monitoring systems

    Time frame: after randomization through end of maintenance phase for a total of 3 months

    Medication event monitoring systems

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Registry information

Official study title

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

Acronym: ECHO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 22, 2017
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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