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Improvement in Medication Adherence Through the Implementation of Personalized Nudges: the ENCOURAGE Trial

NCT ID: NCT02490423

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-02-16

Brief Summary

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This study will determine whether a complex, data-driven protocol for assessing patient needs and providing "nudges" (reminders to be adherent with medication prescriptions) improves adherence with cardiovascular medications. This will be accomplished by performing a 12-month clinical trial of patients with an indication for statin therapy. Participants will be randomized to either an intervention or standard-of-care arm and will be followed via passive electronic means to determine if they are adherent with medication prescriptions.

Detailed Description

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Conditions

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Medication Adherence

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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Nudges Intervention

The intervention arm will employ standard cardiovascular clinical care plus the combination of the MoBe Maps Patient Activation Platform with the Intermountain Risk Score to personalize and deliver motivational nudges to each participant.

Group Type ACTIVE_COMPARATOR

Nudges Intervention

Intervention Type OTHER

The intervention arm will employ standard cardiovascular clinical care plus the combination of the MoBe Maps Patient Activation Platform with the Intermountain Risk Score to personalize and deliver motivational nudges to each participant.

Standard of Care

The standard of care arm will utilize Intermountain cardiovascular clinical program care processes as they are in place today for treatment of the study subjects.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nudges Intervention

The intervention arm will employ standard cardiovascular clinical care plus the combination of the MoBe Maps Patient Activation Platform with the Intermountain Risk Score to personalize and deliver motivational nudges to each participant.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Indication for statin therapy (regardless of statin use history), either: 1) the presence of coronary artery disease (CAD) (either a new diagnosis or prior diagnosis), 2) low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL, 3) the presence of diabetes and LDL-C of 70-189 mg/dL in patients aged 40- 75 years, or 4) CAD-free and diabetes-free patients aged 40-75 years who have LDL-C 70-189 mg/dL and an estimated 10-year risk of CAD ≥7.5% based on the Pooled Cohort Risk Equations (http://my.americanheart.org/professional/StatementsGuidelines/Prevention Guidelines/Prevention-Guidelines\_UCM\_457698\_SubHomePage.jsp)
* Enrollment in a SelectHealth insurance plan
* Age ≥18 years
* Planned discharge to home

Exclusion Criteria

* Age \<18 years
* Alzheimers/Dementia
* Receipt of or expected receipt of palliative care or discharge to hospice, skilled nursing facility, inpatient rehabilitation, or long-term care facility
* Any contraindication to statin agents
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intermountain Research and Medical Foundation

OTHER

Sponsor Role collaborator

CareCentra

UNKNOWN

Sponsor Role collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin D Horne, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Intermountain Medical Center

Joseph B Muhlestein, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Medical Center

Locations

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Intermountain Heart Institute

Murray, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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1040522

Identifier Type: -

Identifier Source: org_study_id