A Wearable EducAtional Intervention to REduce Angina

NCT03134105 | Withdrawn

• 1 other identifier: Pro00081545
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Angina

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 6 months

Secondary Outcomes (3)

• Change in Distance Walked

  Baseline to 6 months

• Change in Angina Frequency

  Baseline to 6 months

• Change in Anti-Anginal Medication

  Baseline to 6 months

Study Arms (2)

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.

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.

Other: End-of-Study Feedback

Interventions

Monthly Feedback on activity and patient-reported angina OTHER

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

Monthly Feedback

End-of-Study Feedback OTHER

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

End-of-study Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Gilead Sciences: collaborator

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: April 28, 2017
• Study Start: September 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share