AnginaAWARENCT03134105
A Wearable EducAtional Intervention to REduce Angina
A study testing Monthly Feedback on activity and patient-reported angina and End-of-Study Feedback in people with Angina, run by Duke University.
Trial summary
The AWARE-Angina study is a cluster randomized trial aimed at evaluating whether routine provider feedback of patients' angina burden and activity level can improve angina control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina
- What is being tested?
- Monthly Feedback on activity and patient-reported angina and End-of-Study Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Jul 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
- Acute MI within the prior 6 months
- At least one-vessel coronary artery disease (≥70% obstruction in any coronary artery or ≥50% in the left main coronary artery)
- English speaking
Who cannot join
- Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
- Non-ambulatory
- Anticipated life expectancy less than 6 months
- Does not own a smartphone operating the iOS or Android operating system
About this study
The AWARE-Angina study is a cluster randomized trial aimed at evaluating whether routine provider feedback of patients' angina burden and activity level can improve angina control. Patients will wear an activity monitor for 6 months, and their providers will be randomized to receive either monthly feedback or feedback at the end of the study period.
Read the detailed description
This is a cluster randomized trial of using a wearable activity monitor to enhance communication between patients with recent acute Myocardial Infarction (MI) and their physicians. After IRB approval, each site will be randomly assigned to either the monthly feedback or the end-of-study feedback arm. All participating providers will participate in an accredited webinar discussing the prevalence of post-MI angina, effects of angina on quality of life and outcomes, and the evidence supporting use of available treatment options. The intention of this approach is to develop a similar baseline understanding of angina among the participants so that knowledge gaps do not interfere with the intervention described below.
Patients at each site who meet the eligibility criteria (acute MI within 6 months with documentation of at least single-vessel coronary artery disease, possession of a smartphone) will be approached for consideration of participation. Those who qualify and express interest will provide informed consent to the study procedures.
At the time of enrollment, patient data (including socio-demographic information, medial history and comorbidities, details of the patient's index MI, secondary prevention medications, and anti-anginal medication prescriptions) will be collected by participating sites for each enrolled patient via a paper data collection form and faxed to a secure fax machine at the DCRI. Patients will also complete a brief survey including questions about angina frequency and quality of life.
All patients will receive a wearable activity tracker (WithingsGO) and smartphone-based app (Withings Health mate). Patients will be instructed on how to put on and take off the wearable activity monitor. They will be instructed to wear the activity monitor continuously while awake for the duration of the study. For the next 6 months, the wearable activity monitor will measure daily step count and distance walked. This data will be transmitted continuously via a Bluetooth connection to the smartphone-based app. The activity monitor application will share activity data through Validic with DCRI IT/CDM through a secure Web Portal. Every other week, patients will receive an email with a link to a Qualtrics survey including questions regarding angina frequency, angina severity, use of short-acting nitroglycerin tablets, and whether they had any overnight hospitalizations in the 2 weeks prior. The survey data will be transmitted to the DCRI through Qualtrics. If patients miss 2 or more consecutive Qualtrics surveys, then representatives from DCRI will contact the patient to complete.
- Conditions
- Angina
- Being tested
- Monthly Feedback on activity and patient-reported angina, End-of-Study Feedback
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly Feedback on activity and patient-reported anginaOther
Providers will receive monthly updates on step count and patient reported angina for each of their patients, with data derived from a wearable fitness tracker and every other week emailed surveys
End-of-Study FeedbackOther
Providers will receive an end-of-study update on step count and patient reported angina for each of their patients, with data derived from a wearable fitness tracker and every other week emailed surveys
| Study group | Role | What they receive |
|---|---|---|
| Monthly Feedback | Experimental | Sites will receive monthly reports of their patients enrolled in the study with data for each of their patients participating in the study along with summary data for their practice and all patients participating in the study. Receives: Other: Monthly Feedback on activity and patient-reported angina |
| End-of-study Feedback | Active comparator | Sites will only receive the report of their patients at the end of the 6 month follow-up period. Receives: Other: End-of-Study Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients' mean daily number of steps
The investigator will plot step count for each patient over the study period and calculate a slope, representing change in number of steps per day enrolled in the study. The research team will calculate a mean slope for patients in each group (monthly feedback versus end-of-study period feedback) and compare between groups. 1. Number of steps will be measured continuously, and the team will evaluate the difference between baseline and 6 months
Measured: Baseline to 6 months
Secondary outcomes (3)
Change in Distance Walked
The investigator will get the daily distance walked from the start of the study to the end
Measured: Baseline to 6 months
Change in Angina Frequency
The investigator will compare between groups the proportion of patients with a reduction in self-reported angina frequency from baseline to 6 months
Measured: Baseline to 6 months
Change in Anti-Anginal Medication
The investigator will look at the proportion of patients initiating a new non-beta blocker anti-anginal medication from baseline to 6 months
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startSep 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Sponsor/funding source decided to not move forward.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies of the same condition, open and under way.
- More trials run by Duke 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will enroll patients with recent myocardial infarction being seen in cardiology clinics. All patients will receive wearable fitness trackers and apps that capture this data and transmit it to the coordinating center; patients will also provide information on angina frequency every other week via emailed surveys. Sites will be randomized to have their providers receive either monthly updates on step count and patient reported angina or a single report at the end of the study period. Providers receiving monthly reports will receive a single report with data for each of their patients participating in the study along with summary data for their practice and all patients participating in the study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134105
- Sponsor's protocol ID
- Pro00081545
- Acronym
- AWARE
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 21 Aug 2017
- 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 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable EducAtional Intervention to REduce Angina
- ClinicalTrials.gov ID
- NCT03134105
- Acronym / sponsor ID
- AWARE / Pro00081545
- Conditions
- Angina
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor/funding source decided to not move forward.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Sep 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Apr 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.
The AWARE-Angina study is a cluster randomized trial aimed at evaluating whether routine provider feedback of patients' angina burden and activity level can improve angina control. Patients will wear an activity monitor for 6 months, and their providers will be randomized to receive either monthly feedback or feedback at the end of the study period.
Detailed description
This is a cluster randomized trial of using a wearable activity monitor to enhance communication between patients with recent acute Myocardial Infarction (MI) and their physicians. After IRB approval, each site will be randomly assigned to either the monthly feedback or the end-of-study feedback arm. All participating providers will participate in an accredited webinar discussing the prevalence of post-MI angina, effects of angina on quality of life and outcomes, and the evidence supporting use of available treatment options. The intention of this approach is to develop a similar baseline understanding of angina among the participants so that knowledge gaps do not interfere with the intervention described below.
Patients at each site who meet the eligibility criteria (acute MI within 6 months with documentation of at least single-vessel coronary artery disease, possession of a smartphone) will be approached for consideration of participation. Those who qualify and express interest will provide informed consent to the study procedures.
At the time of enrollment, patient data (including socio-demographic information, medial history and comorbidities, details of the patient's index MI, secondary prevention medications, and anti-anginal medication prescriptions) will be collected by participating sites for each enrolled patient via a paper data collection form and faxed to a secure fax machine at the DCRI. Patients will also complete a brief survey including questions about angina frequency and quality of life.
All patients will receive a wearable activity tracker (WithingsGO) and smartphone-based app (Withings Health mate). Patients will be instructed on how to put on and take off the wearable activity monitor. They will be instructed to wear the activity monitor continuously while awake for the duration of the study. For the next 6 months, the wearable activity monitor will measure daily step count and distance walked. This data will be transmitted continuously via a Bluetooth connection to the smartphone-based app. The activity monitor application will share activity data through Validic with DCRI IT/CDM through a secure Web Portal. Every other week, patients will receive an email with a link to a Qualtrics survey including questions regarding angina frequency, angina severity, use of short-acting nitroglycerin tablets, and whether they had any overnight hospitalizations in the 2 weeks prior. The survey data will be transmitted to the DCRI through Qualtrics. If patients miss 2 or more consecutive Qualtrics surveys, then representatives from DCRI will contact the patient to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will enroll patients with recent myocardial infarction being seen in cardiology clinics. All patients will receive wearable fitness trackers and apps that capture this data and transmit it to the coordinating center; patients will also provide information on angina frequency every other week via emailed surveys. Sites will be randomized to have their providers receive either monthly updates on step count and patient reported angina or a single report at the end of the study period. Providers receiving monthly reports will receive a single report with data for each of their patients participating in the study along with summary data for their practice and all patients participating in the study.
| Arm | Type | Receives |
|---|---|---|
| Monthly Feedback | Experimental | Other: Monthly Feedback on activity and patient-reported anginaSites will receive monthly reports of their patients enrolled in the study with data for each of their patients participating in the study along with summary data for their practice and all patients participating in the study. |
| End-of-study Feedback | Active comparator | Other: End-of-Study FeedbackSites will only receive the report of their patients at the end of the 6 month follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute MI within the prior 6 months
- At least one-vessel coronary artery disease (≥70% obstruction in any coronary artery or ≥50% in the left main coronary artery)
- English speaking
Key exclusion criteria (4 listed)
- Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
- Non-ambulatory
- Anticipated life expectancy less than 6 months
- Does not own a smartphone operating the iOS or Android operating system
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 |
|---|---|---|
| Monthly Feedback on activity and patient-reported anginaProviders will receive monthly updates on step count and patient reported angina for each of their patients, with data derived from a wearable fitness tracker and every other week emailed surveys | Other | Monthly Feedback |
| End-of-Study FeedbackProviders will receive an end-of-study update on step count and patient reported angina for each of their patients, with data derived from a wearable fitness tracker and every other week emailed surveys | Other | End-of-study Feedback |
Primary outcome
Change in patients' mean daily number of steps
Time frame: Baseline to 6 months
The investigator will plot step count for each patient over the study period and calculate a slope, representing change in number of steps per day enrolled in the study. The research team will calculate a mean slope for patients in each group (monthly feedback versus end-of-study period feedback) and compare between groups. 1. Number of steps will be measured continuously, and the team will evaluate the difference between baseline and 6 months
3 secondary outcomes
Change in Distance Walked
Time frame: Baseline to 6 months
Change in Angina Frequency
Time frame: Baseline to 6 months
Change in Anti-Anginal Medication
Time frame: Baseline to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly Feedback on activity and patient-reported angina and End-of-Study Feedback in people with Angina, run by Duke University.
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 3 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: withdrawn, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Change in patients' mean daily number of steps (time frame: Baseline to 6 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 21 Aug 2017.