Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-30 @ 3:44 PM
Study NCT ID:
NCT05292469
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Approach to Hypertension Management in Nepal
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean systolic blood pressure (BP) (mmHg)', 'timeFrame': 'Measured at baseline and follow up between 7 to 8 months after baseline', 'description': 'Net change in mean systolic BP from baseline to follow up'}], 'secondaryOutcomes': [{'measure': 'Mean diastolic BP (mmHg)', 'timeFrame': 'Measured at baseline and follow up between 7 to 8 months after baseline', 'description': 'Net change in mean diastolic BP from baseline to follow up'}, {'measure': 'Proportion controlling BP (<140/90 mmHg)', 'timeFrame': 'Measured at baseline and follow up between 7 to 8 months after baseline', 'description': 'Proportion of participants controlling BP (\\<140/90 mmHg) from baseline to follow up'}, {'measure': 'Waist Circumference (cm)', 'timeFrame': 'Measured at baseline and follow up between 7 to 8 months after baseline', 'description': 'The mean difference in waist circumference measured at baseline and follow up'}, {'measure': 'Body weight (Kg)', 'timeFrame': 'Measured at baseline and follow up between 7 to 8 months after baseline', 'description': 'The mean difference in weight measured at baseline and follow up'}, {'measure': 'Diet low in cholesterol, high in fruits and vegetables', 'timeFrame': 'Reported at baseline and follow up between 7 to 8 months after baseline', 'description': 'The proportion consuming diet low in cholesterol, high in fruits and vegetables in the last 24 hours self reported at baseline and follow up'}, {'measure': 'Daily salt intake (<1 teaspoon per day)', 'timeFrame': 'Reported at baseline and follow up between 7 to 8 months after baseline', 'description': 'The proportion consuming less than 1 teaspoon of salt per day self reported at baseline and follow up'}, {'measure': 'Medication adherence', 'timeFrame': 'Self reported at baseline and follow up between 7 to 8 months after baseline', 'description': 'The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up'}, {'measure': 'Physical activity', 'timeFrame': 'Self reported at baseline and follow up between 7 to 8 months after baseline', 'description': 'The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up'}, {'measure': 'Hypertension Knowledge Score', 'timeFrame': 'Self reported at baseline and follow up between 7 to 8 months after baseline', 'description': 'All together 21 hypertension knowledge statement with 12 true false responses and others with multiple responses to create a aggregate score on hypertension Knowledge'}, {'measure': 'Perceived Social Support Scale', 'timeFrame': 'Self reported at baseline and follow up between 7 to 8 months after baseline', 'description': 'Twelve statements on perceived social support with 7 point Likert scale will be used at baseline and endline'}, {'measure': 'Maintaining BP logs', 'timeFrame': 'Self reported at follow up between 7 to 8 months after baseline', 'description': 'Proportion of trial participants maintaining self BP measurement logs asked during follow up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nepal', 'Monitoring'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '37169495', 'type': 'BACKGROUND', 'citation': 'Bhattarai S, Shrestha A, Skovlund E, Asvold BO, Mjolstad BP, Sen A. Cluster randomised trial to evaluate comprehensive approach to hypertension management in Nepal: a study protocol. BMJ Open. 2023 May 11;13(5):e069898. doi: 10.1136/bmjopen-2022-069898.'}, {'pmid': '38558834', 'type': 'BACKGROUND', 'citation': 'Bhattarai S, Wagle D, Shrestha A, Asvold BO, Skovlund E, Sen A. Role of Perceived Social Support in Adherence to Antihypertensives and Controlled Hypertension: Findings of a Community Survey from Urban Nepal. Patient Prefer Adherence. 2024 Mar 26;18:767-777. doi: 10.2147/PPA.S455511. eCollection 2024.'}, {'pmid': '39220804', 'type': 'BACKGROUND', 'citation': 'Bhattarai S, Skovlund E, Shrestha A, Mjolstad BP, Asvold BO, Sen A. Impact of a community health worker led intervention for improved blood pressure control in urban Nepal: an open-label cluster randomised controlled trial. Lancet Reg Health Southeast Asia. 2024 Aug 8;29:100461. doi: 10.1016/j.lansea.2024.100461. eCollection 2024 Oct.'}, {'pmid': '37899127', 'type': 'BACKGROUND', 'citation': 'Bhattarai S, Bajracharya S, Shrestha A, Skovlund E, Asvold BO, Mjolstad BP, Sen A. Facilitators and barriers to hypertension management in urban Nepal: findings from a qualitative study. Open Heart. 2023 Oct;10(2):e002394. doi: 10.1136/openhrt-2023-002394.'}]}, 'descriptionModule': {'briefSummary': 'Hypertension is a global risk factor for cardiovascular diseases. Approximately 80% hypertension burden is in low-and-middle income countries. Hypertension can be managed with antihypertensive medication and following effective lifestyle interventions, however the control rate of hypertension among those on treatment is dismal. In Nepal, a quarter of adult population have hypertension of whom, 44% are unaware of their status, 33% are on treatment, and, only 12% are controlled. A comprehensive intervention strategy for hypertension management has shown promising results in high income countries. Therefore, it is of interest to understand its effectiveness, appropriateness and feasibility in the low income settings such as Nepal. The objective of the trial is to assess the impact on net change in mean systolic blood pressure measured between 7 to 8 months follow-up of a comprehensive intervention which provides personalized counselling on lifestyle modification and medication adherence together with support for regular monitoring of blood pressure at home, compared with a control arm where hypertensive patients have access to routine care only. The investigators are proposing a cluster randomized controlled trial conducted in government health facilities from Budhanilakantha, an urban municipality in the Bagmati Province of Nepal. Trial arms: 1) control (routine hypertension care); 2) Comprehensive approach to hypertension management that includes blood pressure (BP) audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change. Eligible participants providing consent will be enrolled into the trial by a research assistant who will conduct interviews. Those from the intervention arm will receive the home visits for 6 months. Participants from both arms will provide follow up data in 7 to 8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertension patients (systolic blood pressure 140 mmHg or more and/or diastolic blood pressure 90 mmHg or more on at least two separate visits, or use of antihypertensive medication)\n* Living in the area served by the participating health facilities\n\nExclusion Criteria:\n\n* Pregnancy\n* Not able or willing to give informed consent,\n* Critically ill from depilating conditions such as dialysis, cancer, palliative care\n* Not likely to continue living in the area served by the health facility during trial follow up period (8 months)'}, 'identificationModule': {'nctId': 'NCT05292469', 'briefTitle': 'Comprehensive Approach to Hypertension Management in Nepal', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'A Cluster Randomized Trial to Evaluate Comprehensive Approach to Hypertension Management in Nepal', 'orgStudyIdInfo': {'id': '399476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Routine hypertension care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Comprehensive approach to hypertension management that includes BP audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change in addition to routine care.', 'interventionNames': ['Behavioral: Comprehensive approach to hypertension management']}], 'interventions': [{'name': 'Comprehensive approach to hypertension management', 'type': 'BEHAVIORAL', 'description': 'Trained health workers will review blood pressure (BP) logs and provide treatment. The patients will receive a BP lowering informational package, BP monitoring device and log book and pill-box and medication table. The participants will receive monthly home visits (6 visits) to discuss hypertension and ways to manage it. They will be encouraged to identify problems and developing an action plan to solve them. The participants will be encouraged to set behavioral goals. The follow up visits will review the progress made in implementing action plan and goals set and updating them. Review BP logs and facilitate tailored discussion on topics based on problems faced by participants on barriers to medication adherence, physical activity, weight management or diet. The family members will be involved and be accountable in supporting the patients in achieving the action plans.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kathmandu', 'country': 'Nepal', 'facility': 'Institute for Implementation Sciences and Health', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}], 'overallOfficials': [{'name': 'Solveig Kirsti Grudt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}, {'name': 'Abhijit Sen, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}, {'name': 'Archana Shrestha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Implementation Sciences and Health, Nepal'}, {'name': 'Sanju Bhattarai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Implementation Science and Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Implementation Sciences and Health, Kathmandu, Nepal', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}