Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Diseases Adherence, Medication Medication Adherence Diabetes Mellitus Hypertension Hyperlipidemias Coronary Artery Disease Atrial Fibrillation | Behavioral: Nudge | Not Applicable |
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.
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, 2022 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
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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.
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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.
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Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
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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.
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Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
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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.
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Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
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Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Sandy, MA | 303-724-5692 | lisa.sandy@ucdenver.edu | |
Contact: Phat Luong, MS | 303-724-8096 | phat.luong@ucdenver.edu |
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 |
Principal Investigator: | Michael Ho, MD, PhD | University of Colorado, Denver | |
Principal Investigator: | Sheana Bull, PhD, MPH | University of Colorado, Denver |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | May 31, 2019 | ||||||||||||||||||
First Posted Date ICMJE | June 4, 2019 | ||||||||||||||||||
Last Update Posted Date | November 4, 2020 | ||||||||||||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||||||||||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications | ||||||||||||||||||
Official Title ICMJE | Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study) | ||||||||||||||||||
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. | ||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | 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 |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||
Estimated Enrollment ICMJE |
5000 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||||||||||||||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 89 Years (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03973931 | ||||||||||||||||||
Other Study ID Numbers ICMJE | 18-2779 UH3HL144163 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Colorado, Denver | ||||||||||||||||||
Study Sponsor ICMJE | University of Colorado, Denver | ||||||||||||||||||
Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | University of Colorado, Denver | ||||||||||||||||||
Verification Date | November 2020 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |