HealtheRx Survey for Pulmonary Research Registry Recruitment

April 27, 2020 updated by: University of Chicago
The purpose of this research is to study the utility of using the HealtheRx as a tool to recruit eligible patients into the Pulmonary Research Registry (PRR) (IRB 15543B) at the University of Chicago. HealtheRx is an example of a potential recruitment tool that has high reach in populations typically underrepresented in research studies, uses a high tech infrastructure that allows matching of research opportunities to patient characteristics, but that delivers information in a low-tech, patient-centered mode using the printed HealtheRx prescription.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Patients living in one of 16 zip codes of the South and West Sides of Chicago who present for care at one or more of 30 clinical sites receive a personalized HealtheRx prescription with programs and services in the community from their health care provider. The HealtheRx is printed and delivered to the patient at the end of the visit.
  2. Patients age 18+ with a diagnosis of asthma and/or COPD will receive a HealtheRx with programs/services to help manage their condition, as well as an advertisement to participate in a phone survey.
  3. Patients interested in completing the phone survey can call or text the Lindau Lab at the University of Chicago.
  4. An experienced survey researcher will first read the consent script and if oral consent is received, continue with the phone survey (The survey includes items pertaining to program participants' receipt of the HealtheRx, use of community services provided on the HealtheRx, thoughts about participation in clinical research.
  5. Participants who choose to complete the survey will receive a $10 check delivered via U.S. mail to their home address. Patients interested in joining the PRR will receive the PRR consent form with their $25 check.
  6. Participants with interest in joining the PRR will also receive, via mail, a $5 bill as thanks for reading, signing and returning the consent form. Participants will be randomized to receive the $5 bill at 2 different time points.
  7. Once the signed consent form is received, a member of the Asthma and COPD Center research staff will contact the participant by phone and complete the PRR case report form by phone.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of asthma/COPD
  • receipt of HealtheRx

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participant is recruited via usual avenues including flyers and physician referral. This includes participants who received a HealtheRx with advertisement for phone survey but did not call in based on advertisement.
Experimental: Intervention with consent form
After completing survey, participant in HealtheRx+ group receives $5 bill with their survey check and blank registry consent form.
Other: HealtheRx+
Participant receives $5 bill with incentive check and blank consent form
Experimental: Intervention with return of consent form
After returning signed consent form, participant in HealtheRx++ group is mailed $5 bill.
Other: HealtheRx++
Participant receives $5 bill when they returned signed PRR consent form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost per consented subject
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean number of consented subjects per week
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Proportion of individuals who consent
Time Frame: 6 months
6 months
Mean days to consent
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Stacy Lindau, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

April 25, 2017

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-1282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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