N/A N=40 Randomized Supportive Care

Heart Failure Medication Adherence

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03402750 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Nov 2019

Primary outcome: Primary: Adherence to Medication — 2; 3 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Meds to Beds (Behavioral); Electronic Prescription (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Adherence to Medication	2; 3	—
PRIMARY Pharmacy Refill Adherence to Medication	7; 6	—
SECONDARY Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire	11.81; 11.50; 8.56; 10.19	—
SECONDARY Number of Participants That Received Their Medications Prior to Discharge.	7; 5	—
SECONDARY Intervention Acceptance	10; 9	—

Summary

The objective of this investigation is to pilot test a medication in-hand intervention (Meds to Beds) compared to standard care for patients with heart failure (ICD-50[all numbers]). The study will evaluate if the intervention improves adherence and physical health, and reduces hospital re-admissions. The study will provide evidence for the feasibility and acceptability of the medication-in-hand intervention.

Eligibility Criteria

Inclusion Criteria

Admission diagnosis of heart failure ICD-50, including I50.1, I50.2, I50.20, I50.21, I50.22, I50.23, I50.3, I50.30, I50.31, I50.32, I50.33, I50.4, I50.40, I50.41, I50.42, I50.43, I50.8, I50.81, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, I50.9, or any combination thereof
Age 18 or older
New York Heart Association Heart Failure Class II or Class III, with ejection fraction below 45%
Cognitively intact, without significant psychological impairment affecting medication adherence such as dementia noted in patient record.

Exclusion Criteria

Medical conditions, such as active cancer or pregnancy, expected to alter heart failure medication management
Discharged to nursing homes or hospice care, where patient may not responsible for their own adherence
High risk of loss to follow-up, e.g., leaving the hospital against medical advice, prisoners, living in a homeless shelter, or unable to provide a phone number
No plan to fill medications at the Jackson Memorial Hospital pharmacy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03402750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.