AsthmaNCT02653066
HealtheRx Survey for Pulmonary Research Registry Recruitment
A study testing HealtheRx+ and HealtheRx++ in people with Asthma and COPD, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- HealtheRx+ and HealtheRx++
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of asthma/COPD
- receipt of HealtheRx
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- 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.
- 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.
- Patients interested in completing the phone survey can call or text the Lindau Lab at the University of Chicago.
- 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.
- 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.
- 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.
- 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.
- Being tested
- HealtheRx+, HealtheRx++
- Keywords
- recruitment
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealtheRx+Other
Participant receives $5 bill with incentive check and blank consent form
HealtheRx++Other
Participant receives $5 bill when they returned signed PRR consent form.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention with consent form | Experimental | After completing survey, participant in HealtheRx+ group receives $5 bill with their survey check and blank registry consent form. Receives: Other: HealtheRx+ |
| Intervention with return of consent form | Experimental | After returning signed consent form, participant in HealtheRx++ group is mailed $5 bill. Receives: Other: HealtheRx++ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost per consented subject
Measured: 6 months
Secondary outcomes (1)
Mean number of consented subjects per week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2015
- Primary completion25 Apr 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Lindau, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653066
- Sponsor's protocol ID
- 15-1282
- Status last verified
- Apr 2020
- First submitted
- 8 Jan 2016
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Feldmeth G, Naureckas ET, Solway J, Lindau ST. Embedding research recruitment in a community resource e-prescribing system: lessons from an implementation study on Chicago's South Side. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):840-846. doi: 10.1093/jamia/ocz059.
PubMed 31181137
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealtheRx Survey for Pulmonary Research Registry Recruitment
- ClinicalTrials.gov ID
- NCT02653066
- Acronym / sponsor ID
- 15-1282
- Keywords
- recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- Patients interested in completing the phone survey can call or text the Lindau Lab at the University of Chicago.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention with consent form | Experimental | Other: HealtheRx+After completing survey, participant in HealtheRx+ group receives $5 bill with their survey check and blank registry consent form. |
| Intervention with return of consent form | Experimental | Other: HealtheRx++After returning signed consent form, participant in HealtheRx++ group is mailed $5 bill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of asthma/COPD
- receipt of HealtheRx
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealtheRx+Participant receives $5 bill with incentive check and blank consent form | Other | Intervention with consent form |
| HealtheRx++Participant receives $5 bill when they returned signed PRR consent form. | Other | Intervention with return of consent form |
Primary outcome
Cost per consented subject
Time frame: 6 months
1 secondary outcome
Mean number of consented subjects per week
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 31181137Feldmeth G, Naureckas ET, Solway J, Lindau ST. Embedding research recruitment in a community resource e-prescribing system: lessons from an implementation study on Chicago's South Side. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):840-846. doi: 10.1093/jamia/ocz059.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Lindau, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealtheRx+ and HealtheRx++ in people with Asthma and COPD, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost per consented subject (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.