Developing Enhanced Prediction Models

NCT02983812 | Completed

• 1 other identifier: 825189
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, patients will be prospectively enrolled for data collection to design prediction models that integrate claims data (inpatient, outpatient, and pharmacy), electronic health record data (on clinical, social, and behavioral indicators), and patient-generated activity data. Patients will be randomized to use either a smartphone or a wearable activity tracking device to capture patient-generated health data.

Conditions

Acute Myocardial Infraction or Chest Pain; Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure (CHF); Diabetes; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Hospital readmission within 30 days of discharge

  Patient readmission within 30 days of initial discharge

  30 days

Secondary Outcomes (4)

• The secondary outcome measures include re-hospitalization within 90 days of discharge.

  90 days

• Re-hospitalization within 6 months of discharge

  6 months

• Emergency department visits within 6 months of discharge

  6 months

• Total health care cost utilization in 6 months after discharge

  6 months

Study Arms (2)

Activity Monitoring - Smartphone

Patients in the activity monitoring - smartphone group will be randomly assigned to track their data using a smartphone app (which collects step counts) for 6 months. There will be no intervention for either group, both are being passively monitored.

Activity Monitoring - Wearable

Patients in the activity monitoring - wearable device group will be randomly assigned to track their data using a wearable activity tracker (which collects step counts and sleep patterns/duration). There will be no intervention for either group, both are being passively monitored.

Eligibility Criteria

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

Study Population

The study population will be drawn from adults admitted to one of the University of Pennsylvania Health System hospitals. Patients will be invited to participate by a member of the research team prior to hospital discharge.

You may qualify if:

• Be 18 years or older
• Be able to provide informed consent
• Be admitted to the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center
• Have a smartphone or tablet compatible with activity tracking devices
• Plan to be discharged to home

You may not qualify if:

• Have no medical condition which prohibits them from ambulating or plan for any medical procedure over the next 6 months that would prohibit them from ambulating.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (2)

• Patel MS, Polsky D, Kennedy EH, Small DS, Evans CN, Rareshide CAL, Volpp KG. Smartphones vs Wearable Devices for Remotely Monitoring Physical Activity After Hospital Discharge: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e1920677. doi: 10.1001/jamanetworkopen.2019.20677.

  PMID: 32031643 DERIVED

• Evans CN, Volpp KG, Polsky D, Small DS, Kennedy EH, Karpink K, Djaraher R, Mansi N, Rareshide CAL, Patel MS. Prediction using a randomized evaluation of data collection integrated through connected technologies (PREDICT): Design and rationale of a randomized trial of patients discharged from the hospital to home. Contemp Clin Trials. 2019 Aug;83:53-56. doi: 10.1016/j.cct.2019.06.018. Epub 2019 Jun 29.

  PMID: 31265915 DERIVED

MeSH Terms

Conditions

Chest Pain; Pulmonary Disease, Chronic Obstructive; Heart Failure; Diabetes Mellitus; Pneumonia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Respiratory Tract Infections; Infections

Study Officials

• Mitesh Patel

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 6, 2016
• Study Start: January 23, 2017
• Primary Completion: June 7, 2019
• Study Completion: December 7, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)