NCT02490423

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2019

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

July 1, 2015

Last Update Submit

October 28, 2020

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • Adherence with taking prescribed statin medications.

    Adherence will be measured by examining the passively-collected data regarding the filling and refilling of the subject's prescriptions that are available electronically through SelectHealth data and calculating the proportion of time during the followup period that each subject had medication (number of days in which the medication was available after a prescription was filled divided by the total length of the follow-up period).

    12 (±1) months

Secondary Outcomes (6)

  • Adherence with taking other individual cardiovascular medications.

    12 (±1) months

  • Adherence with taking all cardiovascular medications.

    12 (±1) months

  • Proportion of adherent subjects per group

    12 (±1) months

  • Clinical Endpoints

    12 (±1) months

  • Adherence with taking individual medications at interim timepoints

    3 months, 6 months, 9 months

  • +1 more secondary outcomes

Study Arms (2)

Nudges Intervention

ACTIVE COMPARATOR

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.

Other: Nudges Intervention

Standard of Care

NO INTERVENTION

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.

Interventions

Nudges InterventionOTHER

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.

Nudges Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Heart Institute

Murray, Utah, 84143, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Benjamin D Horne, PhD, MPH

    Intermountain Medical Center

    PRINCIPAL INVESTIGATOR

  • Joseph B Muhlestein, MD

    Intermountain Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 3, 2015

Study Start

March 1, 2016

Primary Completion

February 16, 2019

Study Completion

February 16, 2019

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

US(1)