Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-28 @ 6:30 AM
Study NCT ID:
NCT01498159
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2011-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Promoters and Pharmacists in Diabetes Team Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058007', 'term': 'Physicians, Primary Care'}, {'id': 'D057286', 'term': 'Electronic Health Records'}, {'id': 'D010595', 'term': 'Pharmacists'}], 'ancestors': [{'id': 'D010820', 'term': 'Physicians'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '24 months', 'description': 'Hemoglobin A1c'}], 'secondaryOutcomes': [{'measure': 'Diabetes Knowledge', 'timeFrame': '24 months', 'description': 'Diabetes Knowledge'}, {'measure': 'Autonomous Self-Regulation', 'timeFrame': '24 months', 'description': 'Autonomous Self-Regulation'}, {'measure': 'Perceived Competence', 'timeFrame': '24 months', 'description': 'Perceived Competence'}, {'measure': 'Medication Adherence', 'timeFrame': '24 months', 'description': 'Medication Adherence'}, {'measure': 'Body mass index', 'timeFrame': '24 months', 'description': 'Body mass index'}, {'measure': 'Diabetes Self-Care Behaviors', 'timeFrame': '24 months', 'description': 'Diabetes Self-Care Behaviors'}, {'measure': 'Quality of Life', 'timeFrame': '24 months', 'description': 'Quality of Life'}, {'measure': 'Healthcare Utilization', 'timeFrame': '24 months', 'description': 'Healthcare Utilization'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '24 months', 'description': 'Systolic Blood Pressure'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '24 months', 'description': 'Diastolic Blood Pressure'}, {'measure': 'LDL Cholesterol', 'timeFrame': '24 months', 'description': 'LDL Cholesterol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Pharmacists', 'Community Health Aides'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '20028957', 'type': 'BACKGROUND', 'citation': 'Gerber BS, Cano AI, Caceres ML, Smith DE, Wilken LA, Michaud JB, Ruggiero LA, Sharp LK. A pharmacist and health promoter team to improve medication adherence among Latinos with diabetes. Ann Pharmacother. 2010 Jan;44(1):70-9. doi: 10.1345/aph.1M389. Epub 2009 Dec 22.'}, {'pmid': '23088168', 'type': 'BACKGROUND', 'citation': 'Gerber BS, Rapacki L, Castillo A, Tilton J, Touchette DR, Mihailescu D, Berbaum ML, Sharp LK. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health. 2012 Oct 23;12:891. doi: 10.1186/1471-2458-12-891.'}, {'pmid': '29121408', 'type': 'RESULT', 'citation': 'Sharp LK, Tilton JJ, Touchette DR, Xia Y, Mihailescu D, Berbaum ML, Gerber BS. Community Health Workers Supporting Clinical Pharmacists in Diabetes Management: A Randomized Controlled Trial. Pharmacotherapy. 2018 Jan;38(1):58-68. doi: 10.1002/phar.2058. Epub 2017 Nov 30.'}, {'pmid': '32115392', 'type': 'DERIVED', 'citation': 'Nabulsi NA, Yan CH, Tilton JJ, Gerber BS, Sharp LK. Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say? J Am Pharm Assoc (2003). 2020 Sep-Oct;60(5):708-715. doi: 10.1016/j.japh.2020.01.024. Epub 2020 Feb 27.'}, {'pmid': '28961153', 'type': 'DERIVED', 'citation': 'Locatelli SM, Sharp LK, Syed ST, Bhansari S, Gerber BS. Measuring Health-related Transportation Barriers in Urban Settings. J Appl Meas. 2017;18(2):178-193.'}], 'seeAlsoLinks': [{'url': 'http://www.ihrp.uic.edu/study/health-promoters-and-pharmacists-diabetes-team-management', 'label': 'IHRP Study Description'}]}, 'descriptionModule': {'briefSummary': 'This research evaluates a diabetes management intervention designed to improve medication adherence and intensify therapy to reach goals in blood sugar, blood pressure, and cholesterol levels. This study will determine the benefit and cost of adding community health promoters to pharmacist disease management services. If there is benefit, then this approach may help reduce the burden of diabetes and its related complications among minorities with diabetes.', 'detailedDescription': 'Many African-Americans and Latinos with diabetes do not achieve the recommended goals for normal blood sugar, blood pressure, or cholesterol level, placing them at high risk for complications. This study will evaluate the impact of a novel intervention designed to improve lifestyle behaviors and medication adherence, and intensify therapy to reach goals. The first component of the intervention includes a clinic-based pharmacist disease management program. The program includes detailed patient assessments, physician-approved treatment plans, patient education and support services to enhance medication adherence. In addition, this program includes intensification of medication therapy to improve blood sugar, blood pressure, and cholesterol levels to reach recommended goals. The second component of the intervention includes health promoters (HPs), or community-based lay health workers. Health promoters are commonly found in minority communities and provide assistance for individuals overcoming language, cultural, and other barriers to conventional health care services. They may provide autonomy support and solve problems related to medication adherence barriers. Furthermore, health promoters may complement pharmacist activities by improving access to medications, assisting in continuity of care with providers, monitoring response to therapy, and reinforcing educational messages. The proposed study will determine whether the addition of health promoters to clinic based pharmacist service delivery improves care. The study will involve the recruitment of 300 African-American and Latino adults with uncontrolled diabetes through the University of Illinois Medical Center in Chicago and randomization to one of two groups: (1) pharmacist management (Pharm) for 12 months; or (2) pharmacist management with HP support (Pharm+HP) for 12 months. Cross-over will occur at 12 months such that the Pharm group will be intensified by the addition of HP support and HP support will be phased out from the Pharm+HP group to assess maintenance. The specific aims include: (1) To evaluate the effectiveness of Pharm+HP compared with Pharm alone on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels; (2) To evaluate the maintenance of improved diabetes behaviors as well as clinical outcomes by phasing out HP support from the Pharm+HP group after year 1; (3) To evaluate the intensification offered by adding an HP after one year of Pharm alone; and (4) To evaluate the cost and cost-effectiveness of Pharm+HP and Pharm alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identified as Latino/Hispanic or African-American\n* Verbal fluency in English or Spanish\n* Age 21 or above\n* History of type 2 diabetes (\\> 1 year)\n* Hemoglobin A1c ≥ 8.0% (within 1 year)\n* Receives primary care at UIMC (\\> 1 year)\n* Taking at least one oral medication for diabetes or hypertension\n\nExclusion Criteria:\n\n* Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)\n* Lives outside Chicago communities of recruitment (3+ months/year)\n* Household member already participating in same study\n* Plans to move from the Chicago area within the next year\n* Pregnant or trying to get pregnancy'}, 'identificationModule': {'nctId': 'NCT01498159', 'briefTitle': 'Health Promoters and Pharmacists in Diabetes Team Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Health Promoters and Pharmacists in Diabetes Team Management', 'orgStudyIdInfo': {'id': '2011-0099'}, 'secondaryIdInfos': [{'id': 'R01DK091347', 'link': 'https://reporter.nih.gov/quickSearch/R01DK091347', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacist + Health Promoter', 'description': 'Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.', 'interventionNames': ['Behavioral: Pharmacist disease/medication management', 'Behavioral: Pharmacist-patient encounters', 'Behavioral: Pharmacist medication intensification and adherence support', 'Behavioral: Pharmacist communication with primary care physicians', 'Behavioral: Pharmacist documentation in electronic medical record', 'Behavioral: Health promoter-patient encounters in-person or by phone', 'Behavioral: Health promoter medication and lifestyle support', 'Behavioral: Health promoter communication with pharmacists']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacist', 'description': 'Participants will receive support from pharmacist.', 'interventionNames': ['Behavioral: Pharmacist disease/medication management', 'Behavioral: Pharmacist-patient encounters', 'Behavioral: Pharmacist medication intensification and adherence support', 'Behavioral: Pharmacist communication with primary care physicians', 'Behavioral: Pharmacist documentation in electronic medical record']}], 'interventions': [{'name': 'Pharmacist disease/medication management', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist', 'Pharmacist + Health Promoter']}, {'name': 'Pharmacist-patient encounters', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist', 'Pharmacist + Health Promoter']}, {'name': 'Pharmacist medication intensification and adherence support', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist', 'Pharmacist + Health Promoter']}, {'name': 'Pharmacist communication with primary care physicians', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist', 'Pharmacist + Health Promoter']}, {'name': 'Pharmacist documentation in electronic medical record', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist', 'Pharmacist + Health Promoter']}, {'name': 'Health promoter-patient encounters in-person or by phone', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist + Health Promoter']}, {'name': 'Health promoter medication and lifestyle support', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist + Health Promoter']}, {'name': 'Health promoter communication with pharmacists', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Pharmacist + Health Promoter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Ben S Gerber, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}, {'name': 'Lisa K Sharp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Ben Gerber', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}