Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT02186067
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2014-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2014-07-09', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP <140 mmHg and DBP < 90mmHg)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Adherence to life style modification', 'timeFrame': '6 months', 'description': 'Adherence to life style modification (exercise, diet, medication) by the patients: This will be assessed through self-report, anthropometric and blood pressure measurement and empty blister count at the follow up visits.'}, {'measure': 'Adherence by physicians to hypertension management guidelines', 'timeFrame': '6 months', 'description': 'Adherence by physicians to hypertension management guidelines: assessed through monthly audits conducted by the research medical officer.'}, {'measure': 'Cost-Effectiveness', 'timeFrame': '6 months', 'description': 'Cost-Effectiveness: cost of medication (self-report by patient), cost of physician visit (clinic data) etc.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '6 months', 'description': 'Patient Satisfaction: This would be assessed through PSQ-18.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Uncontrolled Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertension has become a public health concern worldwide due to its significant contribution to the global health burden and its role as a prominent risk factor for the development of a number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for 57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.\n\nStudies suggest that hypertension is among the top five most common presenting complaints to private general practice clinics. Therefore, primary care physicians/Family physicians are the first line service providers and; thus it is important to manage hypertensive patients early, through lifestyle and treatment interventions that may prevent the complications such as development of CVDs etc.', 'detailedDescription': "To the best of authors' knowledge limited evidence is available from Pakistan on management of hypertension through an integrated approach. Therefore, the aim of the trial is to develop a health delivery system that effectively manages hypertension at primary care level.\n\nHypothesis: The development of an integrated management approach will be effective in managing hypertension at all levels among hypertensive patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 40 years or over visiting the selected IMS centre with known hypertension or with consistently elevated BP on two separate visits (mean of last two of three measurements of systolic pressure ≥140 mm Hg or mean diastolic pressure ≥90 mm Hg) or already receiving treatment will be eligible for inclusion in the study.\n\nExclusion Criteria:\n\n* Those patients who require intensive care unit or coronary care unit admissions, or are diagnosed to have cognitive impairment, are agitated due to severe pain, non-resident of Karachi, or having language barrier will be excluded from the study.\n* A screening form will be designed for the collection of the above mentioned information. The rationale of excluding all the participants with above mentioned condition is that the participants having these health concerns will either not be able to respond to our questionnaire or their presence may confound our results.'}, 'identificationModule': {'nctId': 'NCT02186067', 'briefTitle': 'Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study', 'orgStudyIdInfo': {'id': '13102013FM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Referral System', 'description': 'Referral System:\n\nPrimary Level Secondary Level Tertiary Level', 'interventionNames': ['Other: Referral System']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual/routine care will be provided to the patients'}], 'interventions': [{'name': 'Referral System', 'type': 'OTHER', 'description': 'Primary Level:\n\nRefer patients to secondary care centre if Patients has complicated hypertension (Patients with target organ damage, CVD, CKD or more the 3 drugs)\n\nSecondary Level:\n\nCommunity health center at Aga Khan University will serve as the secondary care center.\n\nFamily physician will manage patients with CVD, CKD or more than 3 drugs.\n\nTertiary care:\n\nCardiologist at the Aga Khan University will manage secondary, resistant and difficult to treat hypertension.\n\nBehavioral: Other Interventions CME session by Cardiologist/Consultant Family Physician : At start , and at two months Community screening by Family physicians at the primary care center (open house) once in three months Patient group education session. Once in three months', 'armGroupLabels': ['Referral System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'The Integrated Medical Services Clinics (IMS)', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Waris Qidwai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman Department of Family Medicine', 'investigatorFullName': 'Waris Qidwai', 'investigatorAffiliation': 'Aga Khan University'}}}}