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

Study Overview
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Brief Summary
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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.

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

Conditions
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Medication Adherence, Heart Failure, Aging

Intervention / Treatment
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* Behavioral: SystemCHANGE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SystemCHANGE intervention<br>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<br>* 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.<br>|
| No Intervention: Attention Control<br>The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures. | |

What is the study measuring?
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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 |