Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT00744458
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2008-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treat Arterial Hypertension and Diabetes in Rural Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000073296', 'term': 'Noncommunicable Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2008-08-29', 'studyFirstSubmitQcDate': '2008-08-29', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with regular follow-up one year after the treatment was started', 'timeFrame': 'One patient year'}], 'secondaryOutcomes': [{'measure': 'Percentage of missed control-visits', 'timeFrame': 'One patient year'}, {'measure': 'Treatment response of diabetic patients (fasting blood glucose)', 'timeFrame': 'One patient year'}, {'measure': 'Treatment response of patients with arterial hypertension (blood pressure)', 'timeFrame': 'One patient year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary Health care in rural Africa', 'Chronic non-communicable diseases', 'Patient Compliance', 'Treatment adherence'], 'conditions': ['Diabetes', 'Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of three different interventions to improve treatment adherence among patients with arterial hypertension or diabetes in rural Cameroon.', 'detailedDescription': 'Non communicable chronic diseases such as arterial hypertension (AH) and diabetes (DM) are a great burden for public health in Cameroon. However, outside the main cities access to appropriate diagnosis and treatment of these health-conditions is still very poor.\n\nThe Swiss NGO "Fondation Coopération Afrique" started in 2007 a program to integrate chronic disease management with focus on AH and DM into the primary health care system of peripheral non-physician health facilities in a rural area of Central Cameroon. A first evaluation after one year revealed very low treatment adherence among the newly diagnosed patients as the main challenge.\n\nIn order to improve patient\'s adherence we expose them randomly to one of three interventions:\n\nThe first intervention consists in a written agreement on long-lasting therapy (treatment contract). Patients get information about the importance of a regular long term treatment and personal engagement to follow treatment and clinical controls regularly.\n\nThe second intervention introduces in addition to the treatment contract a reminder system. In case of follow-up failure a community worker traces the patient to recall the visit at the health centre.\n\nThe third intervention consists of the treatment contract combined with a financial incentive in form of one month free treatment after four months of regular follow-up.\n\nWe allocated randomly one of the three interventions to each health center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed arterial hypertension or non insulin dependent diabetes type 2 which require treatment and can be treated in the health centre\n* Informed consent by the patient\n\nExclusion Criteria:\n\n* Patient already under treatment\n* Patients who need to be referred to a hospital\n* No informed consent by the patient'}, 'identificationModule': {'nctId': 'NCT00744458', 'acronym': 'TAHADIRA', 'briefTitle': 'Treat Arterial Hypertension and Diabetes in Rural Africa', 'organization': {'class': 'OTHER', 'fullName': 'Cooperation Afrique'}, 'officialTitle': 'A Prospective Randomised Trial Comparing Three Interventions to Improve Treatment Adherence Among Patients With Arterial Hypertension or Diabetes in Rural Cameroon (TAHADIRA-trial 1)', 'orgStudyIdInfo': {'id': 'TAHADIRA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Other: Treatment contract']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Other: Treatment contract', 'Other: Tracing and recall at home by a community worker']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Other: Treatment contract', 'Other: Incentive']}], 'interventions': [{'name': 'Treatment contract', 'type': 'OTHER', 'description': 'Patients signs in for a agreement - to respect a regular follow-up at the health facility.', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Tracing and recall at home by a community worker', 'type': 'OTHER', 'description': 'The local health committee sends out a member to trace the patient and to motivate him to take up again regular treatment visits.', 'armGroupLabels': ['2']}, {'name': 'Incentive', 'type': 'OTHER', 'description': 'Incentive by giving free treatment after a 4-month regular follow-up', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Divisions of Mefou and Lékié', 'state': 'Central Province', 'country': 'Cameroon', 'facility': 'Medical districts of Mfou, Mbankomo Obala and Esse in Central Cameroon'}], 'overallOfficials': [{'name': 'Engelbert Manga, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical district officer of Mfou, Ministry of public health of Cameroon'}, {'name': 'Niklaus D Labhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Representant of the foundation Coopération Afrique, Switzerland'}, {'name': 'Beat Stoll, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of social and preventive medicine, University of Geneva, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cooperation Afrique', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Niklaus Labhardt', 'oldOrganization': 'Cooperation Afrique'}}}}