Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Distributed Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898570
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Oliver O. Aalami, Stanford University

Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 2, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date April 1, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2019)
Patient Reported Outcomes (PROs) using mobile app [ Time Frame: 1 Year ]
PROs are any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Distributed Registry
Official Title Distributed Registry Study
Brief Summary The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All adults with an iPhone 5s or higher who can read English
Condition
  • Peripheral Arterial Disease
  • Intermittent Claudication
  • Arteriosclerosis
  • Atherosclerosis
  • Arterial Occlusive Diseases
  • Vascular Diseases
  • Cardiovascular Diseases
  • Peripheral Vascular Diseases
  • Signs and Symptoms
  • Patient Compliance
Intervention Behavioral: Patient reported outcomes

Patients will download the research app onto their phone and enter pertinent medical history and surgical history data similar to standard registries for specific procedures. Over the next 12 months the investigators will obtain patient-reported outcomes (PROs) using the patient's phone.

Specifically, the investigators will obtain daily activity data, weekly 6-minute-walk tests, and quarterly quality of life surveys

Study Groups/Cohorts Patients undergoing vascular surgery procedures
Patients will report outcomes via their smartphone.
Intervention: Behavioral: Patient reported outcomes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 29, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure.
  2. Patients with smartphones (iOS or Android) with unlimited data plans.
  3. Patients who agree to remote surveillance

Exclusion Criteria:

  1. Patients unwilling to download a research study app.
  2. Data plans which are not unlimited.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Doran S Triggs, BS 6508523459 ext 63459 dorant@stanford.edu
Contact: Helle N Nielsen, MPH 6505972031 hnnb@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03898570
Other Study ID Numbers IRB-47517
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Oliver O. Aalami, Stanford University
Study Sponsor Stanford University
Collaborators AstraZeneca
Investigators
Principal Investigator: Oliver O Aalami, MD Stanford University
PRS Account Stanford University
Verification Date May 2019