Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Feasibility of AMDD to Improve Medication Adherence Via Completion Rate
Study Overview
Brief Summary
Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure.
Detailed Description
Background:
Medication adherence [MA] is a complex issue depending on both patient and healthcare factors. Non-adherence due to patient-dependent factors is common; analyses of large broad-based clinical trials in the general population demonstrate that 20-30% of study medication doses may be missed. In community-dwelling HF patients with polypharmacy this percentage is likely even higher. One of the factors in poor adherence in elderly non-HF patients has been shown to be cognitive impairment [CI]. Non-adherence to medical regimen is one factor that is associated with worse outcomes in patients with HF, including readmissions. Measures that improve MA are also likely to improve outcomes.
Objectives:
We evaluated a novel intervention incorporating new technology with the goal of improving adherence in patients with HF and CI. Specific objectives of the study were (1) to assess the feasibility of using the Automated Medication Dispensing Device (AMDD) in veterans with HF and CI by measuring patient qualifying rate, consent rate, user rate, patient-level response rate, medication-level response rate, and success rate, (2) to calculate the improvement of MA based on pill counts before and after the introduction of the AMDD, and (3) qualitatively describe patient satisfaction with the AMDD and the reasons for not using the AMDD.
Methods:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with established diagnosis of clinical heart failure
- •English-speaking
- •Able to provide informed consent
- •Able to participate in cognitive function testing
- •Age over 18
Exclusion Criteria
- •Life expectancy < 6 months
- •Documented dementia requiring a caregiver
- •inability to set up the AMDD at the patient's home due to technical limitations
Arms & Interventions
Automated Medication Dispensing Device
Subjects with <88% medication adherence, determined by 30-day pillcount, and with cognitive impairment (determined by Saint Louis University Mental Status score) proceeded to AMDD portion of study.
Intervention: Automated Medication Dispensing Device (Device)
Outcomes
Primary Outcomes
Feasibility of AMDD to Improve Medication Adherence Via Completion Rate
Time Frame: 4 months
Rate that patient population completed set-up of AMDD was evaluated quantitatively.
Secondary Outcomes
- Efficacy of AMDD to Improve Medication Adherence(30-day pill count before the use of AMDD and with AMDD)