Medication AdherenceENCOURAGENCT02490423
Improvement in Medication Adherence Through the Implementation of Personalized Nudges: the ENCOURAGE Trial
A study testing Nudges Intervention in people with Medication Adherence, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Nudges Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 16 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement in Medication Adherence Through the Implementation of Personalized Nudges
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.
- Conditions
- Medication Adherence
- Being tested
- Nudges Intervention
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 (±1) months
Secondary outcomes (6)
Adherence with taking other individual cardiovascular medications.
Adherence with other individual cardiovascular medications (including beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants). 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).
Measured: 12 (±1) months
Adherence with taking all cardiovascular medications.
Adherence will be measured as a composite of cardiovascular medications including statins, beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants. 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).
Measured: 12 (±1) months
Proportion of adherent subjects per group
Number of patients in each group who were adherent. 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 follow-up 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).
Measured: 12 (±1) months
Clinical Endpoints
A composite of major adverse cardiovascular events and its components, including mortality, myocardial infarction, stroke, and revascularization.
Measured: 12 (±1) months
Adherence with taking individual medications at interim timepoints
Adherence will be measured for individual cardiovascular medications including statins, beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants. 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).
Measured: 3 months, 6 months, 9 months
Adherence with taking the composite of all CV medications at interim timepoints
Adherence will be measured for a composite of cardiovascular medications including statins, beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants. 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).
Measured: 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startMar 2016
- Primary completion16 Feb 2019
- Study completion16 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation, CareCentra
- Responsible party
- Sponsor
- Investigators
- Benjamin D Horne, PhD, MPH, Principal investigator, Intermountain Health Care, Inc.Joseph B Muhlestein, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490423
- Sponsor's protocol ID
- 1040522
- Acronym
- ENCOURAGE
- Status last verified
- Oct 2020
- First submitted
- 1 Jul 2015
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Medication Adherence Through the Implementation of Personalized Nudges
- ClinicalTrials.gov ID
- NCT02490423
- Acronym / sponsor ID
- ENCOURAGE / 1040522
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation, CareCentra
- Study start
- Mar 2016 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nudges Intervention | Active comparator | Other: Nudges InterventionThe 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nudges InterventionThe 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 |
Primary outcome
Adherence with taking prescribed statin medications.
Time frame: 12 (±1) months
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).
6 secondary outcomes
Adherence with taking other individual cardiovascular medications.
Time frame: 12 (±1) months
Adherence with taking all cardiovascular medications.
Time frame: 12 (±1) months
Proportion of adherent subjects per group
Time frame: 12 (±1) months
Clinical Endpoints
Time frame: 12 (±1) months
Adherence with taking individual medications at interim timepoints
Time frame: 3 months, 6 months, 9 months
Adherence with taking the composite of all CV medications at interim timepoints
Time frame: 3 months, 6 months, 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin D Horne, PhD, MPH principal investigator
Intermountain Health Care, Inc.
Joseph B Muhlestein, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudges Intervention in people with Medication Adherence, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence with taking prescribed statin medications. (time frame: 12 (±1) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.