Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03973931
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Adherence, Medication Medication Adherence Diabetes Mellitus Hypertension Hyperlipidemias Coronary Artery Disease Atrial Fibrillation Behavioral: Nudge Not Applicable

Detailed Description:

Background: Up to fifty percent of patients do not take their cardiovascular medications as prescribed resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an intriguing and as of yet untested opportunity to adapt behavioral 'nudges' using ubiquitous cell phone technology to facilitate medication adherence.

Objectives: Aim 1: Conduct a pragmatic patient-level randomized intervention across three health care systems (HCS) to improve adherence to chronic CV medications. The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Secondary outcomes will include intermediate clinical measures (e.g., BP control), CV clinical events (e.g., hospitalizations), healthcare utilization, and costs. Aim 2: Evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. In addition, assess the context and implementation processes to inform local tailoring, adaptations and modifications, and eventual expansion of the intervention within the 3 HCS more broadly and nationally.

Setting: The study will be conducted within three HCS in metro Denver: VA Eastern Colorado Health Care System (VA), Denver Health and Hospital Authority, and UCHealth.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a pragmatic, randomized controlled study with four treatment arms. Once patients are identified through pharmacy refill data to have a 7-day gap in any prescribed CV medication refills, they will be randomized to one of four arms, described in Intervention below. Randomization will be stratified within each of the clinics, and within strata defined by number of other CV medication classes that are prescribed at randomization (1-4), using blocks of 4 patients to ensure balance within clinics over time. Thus, within each clinic and number of other medication stratum, each set of 4 consecutively enrolled subjects will be randomized to the four study arms. Treatments will be initiated immediately upon randomization, in response to the 7-day gap.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
Experimental: Generic Nudge
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.

Experimental: Optimized nudge
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.

Experimental: Optimized nudge plus AI Chat Bot
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.




Primary Outcome Measures :
  1. Medication adherence [ Time Frame: Up to 12 months after intervention ]
    The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data.


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Up to 12 months after intervention ]
    Blood pressure (systolic and diastolic) measurements are defined by the last recorded measurement in months 10-12 following study enrollment.

  2. Low-density lipoproteins (LDL) [ Time Frame: Up to 12 months after intervention ]
    LDL measurements are defined by the last recorded measurement in months 10-12 following study enrollment.

  3. Hemoglobin A1c [ Time Frame: Up to 12 months after intervention ]
    Hemoglobin A1c measurements are defined by the last recorded measurement in months 10-12 following study enrollment.

  4. Hospitalizations rate (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    Hospitalizations due to hypertension emergency, myocardial infarction (MI), stroke, heart failure, hyperglycemia, and atrial fibrillation, are identified by an inpatient stay in the year following study enrollment.

  5. Emergency Department admission rates (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    Emergency Department admissions due to hypertension emergency, myocardial infarction (MI), stroke, heart failure, hyperglycemia, and atrial fibrillation are identified by an event in the year following study enrollment.

  6. Percutaneous coronary intervention (PCI) rates, (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    PCI are identified by a procedure in the year following study enrollment.

  7. Coronary artery bypass graft (CABG) rates, (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    CABG are identified by a procedure in the year following study enrollment.

  8. Cardioversion rates (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    Cardioversion are identified by a procedure in the year following study enrollment.

  9. All-cause hospitalizations (Hospitalizations) [ Time Frame: Up to 12 months after intervention ]
    All-cause hospitalizations are identified by an inpatient stay in the year following study enrollment

  10. All-cause Emergency Department admissions (Hospitalizations) [ Time Frame: Up to 12 months after intervention ]
    All-cause Emergency Department admissions are identified by an event in the year following study enrollment

  11. Implementation costs (Costs) [ Time Frame: Up to 12 months after intervention ]
    The total cost of implementing each intervention to inform the resource use and investment required of each intervention.

  12. Healthcare utilization costs (Costs) [ Time Frame: Up to 12 months after intervention ]
    Healthcare costs and cost offsets associated with the intervention to inform if there were reductions in healthcare utilization.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with the following cardiovascular conditions and respective medication classes:
  • Hypertension (Beta-blockers [B-blockers)], Calcium Channel Blocker [CCB], Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blockers [ARB], or Thiazide diuretic)
  • Hyperlipidemia (HMG CoA reductase inhibitor [Statins])
  • Diabetes (Alpha-glucosidase inhibitors, Biguanides, DPP-4 inhibitors, Sodium glucose transport inhibitor, Meglitinides, Sulfonylureas, Thiazolidinediones, or statins Coronary artery disease P2Y12 inhibitor [Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine], B-blockers, ACEi or ARB or statins)
  • Atrial fibrillation (Direct oral anticoagulants, B-blockers, CCB)

Exclusion Criteria:

  • Patients who do not have a mailing address listed in EHR;
  • Patients who do not have a landline or cellphone listed in EHR;
  • Currently pregnant if denoted in the EHR at the time of the data pull;
  • Patients with a mailing address outside of the state of Colorado;
  • Patients that do not speak either English or Spanish.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973931


Contacts
Layout table for location contacts
Contact: Lisa Sandy, MA 303-724-5692 lisa.sandy@ucdenver.edu
Contact: Phat Luong, MS 303-724-8096 phat.luong@ucdenver.edu

Locations
Layout table for location information
United States, Colorado
Rocky Mountain VA Recruiting
Aurora, Colorado, United States, 80045
Contact: Michael Ho, PhD MD    570-594-1564      
University of Colorado Denver Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Michael Ho, MD, PhD    303-995-8308    michael.ho@ucdenver.edu   
Contact: Sheana Bull, PhD, MPH    303-807-9800    sheana.bull@ucdenver.edu   
Principal Investigator: Michael Ho, MD, PhD         
Principal Investigator: Sheana Bull, PhD, MPH         
Denver Health and Hospital Authority Not yet recruiting
Denver, Colorado, United States, 80204
Contact: Pamela Peterson, MD    303-315-7424    pamela.peterson@dhha.org   
Contact: Suzanne Dircksen, MBA       suzanne.dircksen@dhha.org   
Principal Investigator: Pamela Peterson, MD         
Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Michael Ho, MD, PhD University of Colorado, Denver
Principal Investigator: Sheana Bull, PhD, MPH University of Colorado, Denver

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03973931    
Other Study ID Numbers: 18-2779
UH3HL144163 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Data collected as part of this project will be released in accordance with standard data sharing policies and procedures. Data will be made available to the broader scientific community after results are published in peer-reviewed journals.

Prior to making this data available, data will be redacted to strip identifiers and further de-identified by removing indirect identifiers that could lead to "deductive disclosure" of identities.

Due to the small numbers of participants in the qualitative interviews, we do not anticipate sharing raw data from individuals.

The agreement will prohibit the recipient from transferring the data to other users, require that the data's security be protected by standard means and be used for research purposes only. After a requestor completes the data-sharing agreement, we will either mail a CD with a limited dataset to the requestor, or email the data through our secure email system that requires users to create an account to receive sensitive data.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be shared in a timely manner, as requested.
Access Criteria: The study team will share technical and practical knowledge regarding the creation of the chat bot and text messaging intervention, upon request. Further, the study team would readily share all data collection instruments and assessment algorithms used in the project to qualified individuals within the scientific community with the agreement that they will appropriately acknowledge the study team who developed the instruments.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
cardiovascular disease
telemedicine
medication adherence
behavioral health
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Coronary Artery Disease
Hyperlipidemias
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases