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Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)

Primary Purpose

Coronary Artery Disease, Acute Coronary Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrightHeart®
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Cardiac Rehabiliation, Percutaneous Coronary Intervention, Cardiovascular Risk Factor, Digital Health Solution, Medication Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

I. ≥ 18 years of age

II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25).

III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge

IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an active phone number and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. Wi-Fi internet capability is not a substitute for an active cellular data plan.

V. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

VI. Willing to have the mobile application installed on a smartphone and use it every day during the entire study period VII. Willing to provide oral confirmation indicating that he/she is currently not using a medication adherence application.

VIII. Ability to read and understand English.

Exclusion criteria:

Any potential participant who meets any of the following criteria will be excluded from participating in the study:

I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).

II. Current use of adherence tracking devices, electronic, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion.

a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion.

III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone. Co-morbidities that would preclude participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve replacement) IV. End-stage of one of the following: heart failure (using left ventricular assist device or listed for heart transplantation), renal disease, lung disease, liver disease.

V. Any condition with a life expectancy less than 3 months. VI. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator VII. Any other condition as determined by the PI.

Sites / Locations

  • Stanford Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

smartphone-based cardiac rehabilitation

Control

Arm Description

The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.

Standard-of-care alone.

Outcomes

Primary Outcome Measures

Medication adherence
The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.

Secondary Outcome Measures

Medication adherence II
Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
Medication adherence III
The PDC of each medication of the composite
Medication adherence IV
Proportion of participants with PDC ≥ 80% of each of the composite
Medication adherence V
Mean time from discharge to first fill
Medication persistence
proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
Cardiovascular risk factors I
Serum LDL-C at End of Study
Cardiovascular risk factors II
Proportion of participants within target blood pressure (<140/90 mmHg or <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study
Cardiovascular risk factors III
Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
Cardiovascular risk factors IV
Change in body weight from baseline to End of Study
Cardiovascular risk factors V
Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
Cardiovascular risk factors VI
Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
Cardiovascular risk factors VII
Physical activity at End of Study (measured by a physical acitivity questionnaire)
Exploratory I: Rehospitalization
30-day rehospitalization for any reason
Exploratory II: Cardiovascular outcomes
Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days

Full Information

First Posted
June 16, 2017
Last Updated
September 6, 2018
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03207646
Brief Title
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease
Acronym
smartGUIDE
Official Title
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
The company that provided the intervention shut down & withdrew the intervention
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
August 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates a smartphone-based cardiac rehabilitation program in adults with coronary artery disease. Half of patients will participate in a smartphone-based cardiac rehabilitation program while the other half will receive standard-of-care.
Detailed Description
Cardiac rehabilitation as a means to improve lifestyle-based risk factor modification, remains poorly prescribed and utilized, often due to the lack of access to programs, poor insurance coverage, cost, or patient or physician motivational factors. Low-cost solutions that can improve patient adherence to medications, risk factor reduction, and exercise could improve cardiovascular outcomes and cost-effectiveness compared to current care models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Coronary Syndrome
Keywords
Cardiac Rehabiliation, Percutaneous Coronary Intervention, Cardiovascular Risk Factor, Digital Health Solution, Medication Adherence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 to either the experimental arm or the 'no intervention' (control) arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
smartphone-based cardiac rehabilitation
Arm Type
Experimental
Arm Description
The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard-of-care alone.
Intervention Type
Other
Intervention Name(s)
BrightHeart®
Intervention Description
BrightHeart® has two components: smartphone mobile based application and a human coach. It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
Primary Outcome Measure Information:
Title
Medication adherence
Description
The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Secondary Outcome Measure Information:
Title
Medication adherence II
Description
Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Medication adherence III
Description
The PDC of each medication of the composite
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Medication adherence IV
Description
Proportion of participants with PDC ≥ 80% of each of the composite
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Medication adherence V
Description
Mean time from discharge to first fill
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Medication persistence
Description
proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Cardiovascular risk factors I
Description
Serum LDL-C at End of Study
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Cardiovascular risk factors II
Description
Proportion of participants within target blood pressure (<140/90 mmHg or <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Cardiovascular risk factors III
Description
Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Cardiovascular risk factors IV
Description
Change in body weight from baseline to End of Study
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Cardiovascular risk factors V
Description
Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Cardiovascular risk factors VI
Description
Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Cardiovascular risk factors VII
Description
Physical activity at End of Study (measured by a physical acitivity questionnaire)
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Exploratory I: Rehospitalization
Description
30-day rehospitalization for any reason
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.
Title
Exploratory II: Cardiovascular outcomes
Description
Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days
Time Frame
Baseline through End of Study visit - approximately 90 days per participant.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: I. ≥ 18 years of age II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25). III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an active phone number and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. Wi-Fi internet capability is not a substitute for an active cellular data plan. V. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. VI. Willing to have the mobile application installed on a smartphone and use it every day during the entire study period VII. Willing to provide oral confirmation indicating that he/she is currently not using a medication adherence application. VIII. Ability to read and understand English. Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI). II. Current use of adherence tracking devices, electronic, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion. a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion. III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone. Co-morbidities that would preclude participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve replacement) IV. End-stage of one of the following: heart failure (using left ventricular assist device or listed for heart transplantation), renal disease, lung disease, liver disease. V. Any condition with a life expectancy less than 3 months. VI. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator VII. Any other condition as determined by the PI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minang (Mintu) Turakhia, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Healthcare
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease

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