NCT04285047

Brief Summary

APEX COPD is registry to provide a mechanism to standardize, store and utilize data to enable greater power to answer key research questions, and to improve patient outcomes in COPD primary care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

3.8 years

First QC Date

February 23, 2020

Last Update Submit

February 23, 2020

Conditions

Chronic Obstructive Pulmonary Disease (13645005)

Keywords

Chronic Obstructive Pulmonary DiseaseChronic Obstructive Lung DiseaseChronic Obstructive Airway DiseaseRegistryElectronic Health RecordElectronic Medical RecordPatient Reported Information and OutcomesTreatmentTherapy

Outcome Measures

Primary Outcomes (2)

  • Describe and characterize the COPD primary care patient population's natural history

    Baseline data from electronic health record (EHR) and patient reported information and outcomes (PRIO). The EHR data will be updated every three months.

    31 December 2018 to 31 December 2022

  • Evaluate the comparative clinical, safety and cost effectiveness of current COPD treatments by class of therapy for COPD overall and in specific patient groups/phenotypes, to understand the predictors of response to available COPD treatment options

    Patient reported information and outcomes (PRIO) will be collected annually and before very visit to their doctor

    31 December 2018 to 31 December 2022

Secondary Outcomes (12)

  • Improve quality of care, and primary care patient outcomes

    31 December 2018 to 31 December 2022

  • Understand the clinical phenotypes

    31 December 2018 to 31 December 2022

  • Understand the current burden and minimize side effects

    31 December 2018 to 31 December 2022

  • Support the development of effective and efficient diagnostic routines

    31 December 2018 to 31 December 2022

  • comparing clinician-diagnosed COPD at baseline against established

    31 December 2018 to 31 December 2022

  • +7 more secondary outcomes

Interventions

Advancing Patient Experience (APEX) in COPDOTHER

Involves both EMR and PRIO data

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study populations comprise of patients aged over 35 years and receiving care for COPD at participating primary care sites across the US in accordance with local regulatory/ethical requirements.

You may qualify if:

  • Diagnostic code for COPD or COPD monitoring review code prior to or at consultation
  • Aged ≥35 years at COPD diagnosis

You may not qualify if:

  • Patients receiving hospice care
  • Patients being actively treated for a cancer diagnosis (not skin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Miramont Family Medicine

Fort Collins, Colorado, 80528, United States

Location

Urban Family Practice

Buffalo, New York, 14201, United States

Location

MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Bandera Family Health Care

San Antonio, Texas, 78249, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wilson D Pace, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 26, 2020

Study Start

March 23, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

US(4)