Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-09 @ 11:14 AM
Study NCT ID:
NCT00207194
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period', 'timeFrame': '8 months', 'description': 'Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.'}, {'measure': '2-consumption of more than 5 servings of fruits and vegetables a day, less than 30% of calories from fat, and less than 2400 mg of sodium a day at the end of the intervention period', 'timeFrame': '8 months', 'description': 'Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.'}, {'measure': '3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period', 'timeFrame': '8 months', 'description': 'Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.'}], 'secondaryOutcomes': [{'measure': '1-TLC-HTN-AA use will reduce the mean blood pressure and the proportion of the treatment group having uncontrolled hypertension at the end of the intervention period', 'timeFrame': '8 months', 'description': 'Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '22246660', 'type': 'RESULT', 'citation': 'Migneault JP, Dedier JJ, Wright JA, Heeren T, Campbell MK, Morisky DE, Rudd P, Friedman RH. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive African-Americans: a randomized controlled trial. Ann Behav Med. 2012 Feb;43(1):62-73. doi: 10.1007/s12160-011-9319-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the efficacy of Telephone-Linked\\_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to medication, diet, and exercise. The primary hypotheses are:\n\n1. TLC-HTN-AA use will improve medication regiment adherence\n2. TLC-HTN-AA will improve adherence to 3 healthy diet recommendations\n3. TLC-HTN-AA will improve levels of regular exercise\n4. Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* a patient with a primary care provider at one of Boston Medical Center's Adult Primary Care Medical Practices or one of three HealthNet health centers participating in the study\n* have a physician diagnosis of hypertension\n* be African American by self-report\n* be 35 years of age or older\n* be prescribed at least one medication for hypertension\n* have poorly controlled blood pressure\n* be non-adherent to at least one hypertensive medication\n* understand spoken English\n* have a home telephone\n\nExclusion Criteria:\n\n* patients for whom a medication, diet or exercise regiment adherence improvement or maintenance program would be inappropriate\n* patients with a terminal illness\n* patients with severe medical or psychiatric illness\n* patients with cognitive difficulty"}, 'identificationModule': {'nctId': 'NCT00207194', 'briefTitle': 'Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Interactive Multirisk-Factor Intervention for HTN Blacks', 'orgStudyIdInfo': {'id': 'HL 69395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Automated Telephone Program', 'description': "The intervention was a totally automated, computer-based, interactive telephone counseling system called Telephone- Linked-Care, designed to monitor, educate, and counsel African-American adults with hypertension and to provide summary data regularly to the patient's primary care provider.", 'interventionNames': ['Behavioral: Automated Telephone Program', 'Behavioral: Health Behavior Education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Health Behavior Education', 'description': 'The comparator group received health education relating to the management of hypertension. Members of this group also received standard primary medical care.', 'interventionNames': ['Behavioral: Health Behavior Education']}], 'interventions': [{'name': 'Automated Telephone Program', 'type': 'BEHAVIORAL', 'description': "The intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values. Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.). These participants also received the same health behavior education those in the control condition received.", 'armGroupLabels': ['Automated Telephone Program']}, {'name': 'Health Behavior Education', 'type': 'BEHAVIORAL', 'description': 'Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).', 'armGroupLabels': ['Automated Telephone Program', 'Health Behavior Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Medical Information Systems Unit/Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Robert Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}, {'name': 'Jeffrey Migneault, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BUMC Faculty', 'investigatorFullName': 'Julien Dedier', 'investigatorAffiliation': 'Boston Medical Center'}}}}