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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02653066
Other study ID # 15-1282
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date December 2019

Study information

Verified date April 2020
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date December 2019
Est. primary completion date April 25, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diagnosis of asthma/COPD

- receipt of HealtheRx

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HealtheRx+
Participant receives $5 bill with incentive check and blank consent form
HealtheRx++
Participant receives $5 bill when they returned signed PRR consent form.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of individuals who consent 6 months
Other Mean days to consent 6 months
Primary Cost per consented subject 6 months
Secondary Mean number of consented subjects per week 6 months
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