NCT03402750

Heart Failure Medication Adherence

Completed NA Results posted Last updated 7 November 2019

What this trial tests

NA trial testing Meds to Beds in Heart Failure in 40 participants. Completed in 8 April 2019.

Timeline

28 May 2018

Primary endpoint
8 April 2019

8 April 2019

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	28 May 2018
Primary completion	8 April 2019
Estimated completion	8 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Meds to Beds
• Electronic Prescription

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adherence to Medication Primary · Day 30

Adherence to medication will be reported as the number of participants that scores 12 and lower in a self-reported Adherence to Refills and Medications Scale (ARMS) Questionnaire. The questionnaire has 12 items with each item being recorded on a four-point Likert scale. The total score ranges from 12-48 with the lower score indicating better adherence.

Group	Value	95% CI
Meds to Beds	2
Standard Care	3

Pharmacy Refill Adherence to Medication Primary · Day 30

Medication adherence will be reported as the number of participants that completed their expected pharmacy refill. Standard Care participants are expected to complete one initial fill and one refill. Meds to Beds participants are expected to complete one pharmacy refill as the initial fill is handed upon discharge.

Group	Value	95% CI
Meds to Beds	7
Standard Care	6

Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire Secondary · Baseline and Day 30

Physical health is measured using the 10 item PROMIS questionnaire. Responses are recorded along a 5-point Likert scale with a total score ranging from 10-50. A higher score indicates better physical health.

30-Day follow-up

Group	Value	95% CI
Meds to Beds	11.81	± 4.09
Standard Care	11.50	± 3.90

Baseline/Discharge

Group	Value	95% CI
Meds to Beds	8.56	± 3.16
Standard Care	10.19	± 3.51

Number of Participants That Received Their Medications Prior to Discharge. Secondary · Day 0

The program's feasibility will be evaluated by tracking whether medications can be successfully delivered (i.e., before discharge) to patients in the Meds to Beds condition. This measure will be evaluated as a proportion within the intervention condition.

Group	Value	95% CI
Meds to Beds	7
Standard Care	5

Intervention Acceptance Secondary · Day 30

All participants will be asked one question about the acceptability of the intervention program. Responses for acceptability items will be recorded on a 10-point scale (1, very unsatisfactory - 10, very satisfactory). Dichotomized due to extreme skew. Intervention acceptance will be reported as the number of participants that provides a score of 1 and higher.

Group	Value	95% CI
Meds to Beds	10
Standard Care	9

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Meds to Beds

Serious: 1/20 (5%)

Deaths: 1/20

Standard Care

Serious: 1/20 (5%)

Deaths: 1/20

Serious adverse events (1 terms)

Reaction	System	Meds to Beds	Standard Care
Death	Cardiac disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03402750 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.