Heart Failure Medication Adherence

NCT ID: NCT03402750

Last Updated: 2019-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2019-04-08

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Meds to Beds

Patients receive medication in-hand at discharge from the hospital

Group Type EXPERIMENTAL

Meds to Beds

Intervention Type BEHAVIORAL

Medications will be delivered to patient bedside before discharge

Standard Care

Electronic prescription with patient pickup at the pharmacy

Group Type ACTIVE_COMPARATOR

Electronic Prescription

Intervention Type BEHAVIORAL

Patient or surrogate can pick up medication from pharmacy

Interventions

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Meds to Beds

Medications will be delivered to patient bedside before discharge

Intervention Type BEHAVIORAL

Electronic Prescription

Patient or surrogate can pick up medication from pharmacy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beta Tau Chapter of Sigma Theta Tau International

UNKNOWN

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Brian McCabe

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian E McCabe, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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20160741

Identifier Type: -

Identifier Source: org_study_id

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