A Wearable EducAtional Intervention to REduce Angina
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 03/31/2017 |
| Primero enviado: | 04/25/2017 |
| Inscripción estimada enviada: | 04/26/2017 |
| Publicado por primera vez: | 04/27/2017 |
| Última actualización enviada: | 08/15/2017 |
| Última actualización publicada: | 08/20/2017 |
| Fecha de inicio real del estudio: | 08/31/2017 |
| Fecha estimada de finalización primaria: | 01/31/2018 |
| Fecha estimada de finalización del estudio: | 06/30/2018 |
Condición o enfermedad
Intervención / tratamiento
Other: Monthly Feedback
Other: End-of-study Feedback
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Monthly Feedback 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 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 |
| Active Comparator: End-of-study Feedback Sites will only receive the report of their patients at the end of the 6 month follow-up period. | Other: End-of-study Feedback 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 |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. Acute MI within the prior 6 months 2. At least one-vessel coronary artery disease (≥70% obstruction in any coronary artery or ≥50% in the left main coronary artery) 3. English speaking Exclusion Criteria: 1. Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension) 2. Non-ambulatory 3. Anticipated life expectancy less than 6 months 4. Does not own a smartphone operating the iOS or Android operating system |
Salir
Medidas de resultado primarias
1. Change in patients' mean daily number of steps [Baseline to 6 months]
Medidas de resultado secundarias
1. Change in Distance Walked [Baseline to 6 months]
2. Change in Angina Frequency [Baseline to 6 months]
3. Change in Anti-Anginal Medication [Baseline to 6 months]
