Aging, Heart Failure, Medication Adherence
Conditions
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.
Interventions
BEHAVIORALSystemCHANGE
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.
Sponsors
University of Missouri, Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed