Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT02653066
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HealtheRx Survey for Pulmonary Research Registry Recruitment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-27', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of individuals who consent', 'timeFrame': '6 months'}, {'measure': 'Mean days to consent', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Cost per consented subject', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Mean number of consented subjects per week', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recruitment'], 'conditions': ['Asthma', 'COPD']}, 'referencesModule': {'references': [{'pmid': '31181137', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n2. 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.\n3. Patients interested in completing the phone survey can call or text the Lindau Lab at the University of Chicago.\n4. 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.\n5. 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.\n6. 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.\n7. 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of asthma/COPD\n* receipt of HealtheRx\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02653066', 'briefTitle': 'HealtheRx Survey for Pulmonary Research Registry Recruitment', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'HealtheRx Survey for Pulmonary Research Registry Recruitment', 'orgStudyIdInfo': {'id': '15-1282'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention with consent form', 'description': 'After completing survey, participant in HealtheRx+ group receives $5 bill with their survey check and blank registry consent form.', 'interventionNames': ['Other: HealtheRx+']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention with return of consent form', 'description': 'After returning signed consent form, participant in HealtheRx++ group is mailed $5 bill.', 'interventionNames': ['Other: HealtheRx++']}], 'interventions': [{'name': 'HealtheRx+', 'type': 'OTHER', 'description': 'Participant receives $5 bill with incentive check and blank consent form', 'armGroupLabels': ['Intervention with consent form']}, {'name': 'HealtheRx++', 'type': 'OTHER', 'description': 'Participant receives $5 bill when they returned signed PRR consent form.', 'armGroupLabels': ['Intervention with return of consent form']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Stacy Lindau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}