Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 10:30 PM
Study NCT ID:
NCT06379750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-14
First Post:
2024-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '12 months', 'description': 'Change in systolic blood pressure from baseline to last follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Blood pressure control', 'timeFrame': '12 months', 'description': 'Proportion of participants with controlled blood pressure (\\<140 mm Hg for systolic and \\<90 mm Hg for diastolic) at the last follow-up visit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'diabetes', 'NCD management', 'NCD prevention', 'mHealth', 'healthcare financing'], 'conditions': ['Hypertension', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. The investigators will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. The investigators will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, the investigators will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which the investigators evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which the investigators use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. The investigators will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.\n\nExclusion Criteria:\n\n* Adults with controlled HTN or those without a diagnosis of HTN\n* Unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06379750', 'briefTitle': 'Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'STOP NCDs: Scaling Up Evidence-based Health System Interventions Through the Use of Sustainable Healthcare Financing and Digital TechnOlogy Platforms to Improve Non- Communicable Disease Prevention and Control in Tanzania', 'orgStudyIdInfo': {'id': 'STOPNCD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Enhanced Usual Care (EUC)', 'description': 'Enhanced usual care provided by facility MD or equivalent (control group)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EUC + community support', 'description': 'Enhanced usual care AND community-based peer-support model using WelTel check-ins and BCC SMS and facilitated group self monitoring', 'interventionNames': ['Other: Community-based peer-support model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EUC + nurse-delivered check ins', 'description': 'Enhanced usual care AND nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management using WelTel check-ins and BCC SMS', 'interventionNames': ['Other: Nurse-delivered care using WelTel check-ins and BCC SMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EUC + community support + nurse-delivered check ins', 'description': 'Enhanced usual care AND nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management using WelTel check-ins and BCC SMS AND community-based peer-support model using WelTel check-ins and BCC SMS and facilitated group self monitoring', 'interventionNames': ['Other: Nurse-delivered care using WelTel check-ins and BCC SMS', 'Other: Community-based peer-support model']}], 'interventions': [{'name': 'Nurse-delivered care using WelTel check-ins and BCC SMS', 'type': 'OTHER', 'description': 'Nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS', 'armGroupLabels': ['EUC + community support + nurse-delivered check ins', 'EUC + nurse-delivered check ins']}, {'name': 'Community-based peer-support model', 'type': 'OTHER', 'description': 'Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring', 'armGroupLabels': ['EUC + community support', 'EUC + community support + nurse-delivered check ins']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Kilimanjaro Clinical Research Institute', 'class': 'OTHER'}, {'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Karen Yeates', 'investigatorAffiliation': "Queen's University"}}}}