Skip to main content
OpenTrials
Completed

NCT Number: NCT03402750

Heart Failure Medication Adherence

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meds to Beds

Behavioral

Medications will be delivered to patient bedside before discharge

Electronic Prescription

Behavioral

Patient or surrogate can pick up medication from pharmacy

Primary outcomes

  1. Adherence to Medication

    Time frame: 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.

  2. Pharmacy Refill Adherence to Medication

    Time frame: 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.

Secondary outcomes

  1. Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire

    Time frame: 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.

  2. Number of Participants That Received Their Medications Prior to Discharge.

    Time frame: 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.

  3. Intervention Acceptance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Beta Tau Chapter of Sigma Theta Tau International

Registry information

Official study title

Heart Failure Medication Adherence Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2018
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.