Coronary Artery DiseasesmartGUIDENCT03207646
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease
A study testing BrightHeart® in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- BrightHeart®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 17 Aug 2018
- 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
- ≥ 18 years of age
- 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).
- Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge
- 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.
- 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.
- 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.
- Ability to read and understand English.
Who cannot join
- Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- BrightHeart®
- Keywords
- Cardiac Rehabiliation, Percutaneous Coronary Intervention, Cardiovascular Risk Factor, Digital Health Solution, Medication Adherence
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrightHeart®Other
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.
| Study group | Role | What they receive |
|---|---|---|
| smartphone-based cardiac rehabilitation | Experimental | The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program. Receives: Other: BrightHeart® |
| Control | No intervention | Standard-of-care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Secondary outcomes (14)
Medication adherence II
Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence III
The PDC of each medication of the composite
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence IV
Proportion of participants with PDC ≥ 80% of each of the composite
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence V
Mean time from discharge to first fill
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Medication persistence
proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors I
Serum LDL-C at End of Study
Measured: Baseline through End of Study visit - approximately 90 days per participant.
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
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors III
Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors IV
Change in body weight from baseline to End of Study
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors V
Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VI
Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VII
Physical activity at End of Study (measured by a physical acitivity questionnaire)
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Exploratory I: Rehospitalization
30-day rehospitalization for any reason
Measured: Baseline through End of Study visit - approximately 90 days per participant.
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
Measured: Baseline through End of Study visit - approximately 90 days per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start19 Jul 2017
- Primary completion9 May 2018
- Study completion17 Aug 2018
Why it stopped: The company that provided the intervention shut down \& withdrew the intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to either the experimental arm or the 'no intervention' (control) arm.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mintu Turakhia, Stanford University
- Investigators
- Minang (Mintu) Turakhia, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207646
- Sponsor's protocol ID
- 39555
- Acronym
- smartGUIDE
- Status last verified
- Sep 2018
- First submitted
- 16 Jun 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
- ClinicalTrials.gov ID
- NCT03207646
- Acronym / sponsor ID
- smartGUIDE / 39555
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- Cardiac Rehabiliation, Percutaneous Coronary Intervention, Cardiovascular Risk Factor, Digital Health Solution, Medication Adherence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The company that provided the intervention shut down \& withdrew the intervention
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 5 Jul 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either the experimental arm or the 'no intervention' (control) arm.
| Arm | Type | Receives |
|---|---|---|
| smartphone-based cardiac rehabilitation | Experimental | Other: BrightHeart®The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program. |
| Control | No intervention | –Standard-of-care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- 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).
- Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge
- 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.
- 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.
Key exclusion criteria (6 listed)
- Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).
- 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.
- 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.
- 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.
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 |
|---|---|---|
| BrightHeart®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. | Other | smartphone-based cardiac rehabilitation |
Primary outcome
Medication adherence
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
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.
14 secondary outcomes
Medication adherence II
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence III
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence IV
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence V
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication persistence
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors I
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors II
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors III
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors IV
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors V
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VI
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VII
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Exploratory I: Rehospitalization
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Exploratory II: Cardiovascular outcomes
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Results and safety
The study was stopped early (reason given: The company that provided the intervention shut down \& withdrew the intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Minang (Mintu) Turakhia, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrightHeart® in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Stanford University 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Sep 2018. 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 was stopped early (reason given: The company that provided the intervention shut down \& withdrew the intervention). Results are not available in the source record.
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?
Medication adherence (time frame: Baseline through End of Study visit - approximately 90 days per participant.). 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 10 Sep 2018.