Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 2:55 AM
Study NCT ID:
NCT05979168
Status:
UNKNOWN
Last Update Posted:
2023-08-09
First Post:
2023-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will use a two-arm parallel-group, individually randomized control trial design to test the effectiveness of a TelTex4BP intervention compared to standard care at one year among diagnosed patients of HTN.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2023-07-30', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'baseline, 6 and 12 months', 'description': 'Average of last of two measures of Blood pressure.'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Control', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Measures of Systolic and diastolic BP'}, {'measure': '10 year risk of development of CVD', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Globo CVD risk calculator'}, {'measure': 'Medication adherence', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Hill-Bone compliance to high blood pressure therapy scale will be use to measure adherence to antihypertensive therapy. This tool contains 14 items: nine items related to medication, three items on salt intake and two items on appointment keeping. Each item is scored on a response of 1-4. The total score of Hill Bone is 56 where a lower score indicates higher adherence to antihypertensive therapy.'}, {'measure': 'Dietary habits (salt intake, fruits and vegetables intake)', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Dietary salt \\[9 items\\] based on the WHO STEPs survey'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Physical activity \\[17 items\\]based on the WHO STEPs survey'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile Intervention', 'Blood Pressure Control', 'Hypertension', 'Randomized Controlled Trial'], 'conditions': ['Hypertension', 'Medication Adherence', 'Blood Pressure', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Despite evidence of preventing cardiovascular disease (CVD) risk through lifestyle changes, many patients with hypertension (HTN) do not comply with this and suffer from CVD and other complications. A previous study using a structured lifestyle intervention program has reported a 14% decrease in the 10-year risk of developing CVD at one year among hypertensive and diabetes patients. Low and Middle-Income countries (LMICs) struggle with a shortage of health workers to deliver such interventions. In this context, mobile phones can contribute to bridging this gap by incorporating them into the health system for health intervention delivery. There is a need to develop contextual mHealth intervention adapted to local needs and culture and test its effectiveness in LMIC settings like Nepal. Our previous small-scale pilot mHealth (text messages) study reported promising evidence in reducing blood pressure among hypertensive patients in the intervention arm \\[adjusted reduction in systolic blood pressure (BP) -6.50 (95% CI, -12.6; -0.33) and diastolic BP -4.60 (95% CI, -8.16; -1.04)\\], with a greater proportion achieving target BP (70% vs 48% in the control arm, p = 0.006)\\] and improving treatment compliance (p \\< 0.001) in Nepal. This finding supports the expansion to a large-scale trial of a structured mHealth intervention to see its long-term effectiveness and sustainability for patients with HTN to improve BP control and reduce CVD risk. Hence, this study aims to assess the effectiveness of a behavioural intervention through mHealth (telephone/mobile phone calls and text messages) informed by the RE-AIM framework for improving blood pressure control among patients with hypertension in a hospital (Manamohan Cardiothoracic Vascular and Transplant Center) of Kathmandu, Nepal.', 'detailedDescription': 'This study will be a hybrid type 2 effectiveness-implementation study using mixed methods, a parallel randomized controlled trial with a nested qualitative design. The intervention will be codesigned involving patients, their family members, and healthcare providers to incorporate their views, the local context and culture through a formative qualitative component informed by the COM-B model. A multi-component mHealth intervention will be delivered through text messages and phone calls (TelTex4BP) by nurses, focusing on behaviour changes (physical activity, healthy diet), medication adherence, a reminder for follow-up, smoking, and alcohol intake. The intervention will be delivered for six months, and follow-up will be carried out at the end of the intervention and six months later (at one year) to assess sustainability and long-term effectiveness. Clinical (blood pressure, 10-year risk of CVD), intermediate (medication adherence, change of dietary habits/physical activity), and implementational outcomes ( Reach, Adoption, Intervention fidelity and Maintenance) will be evaluated using the RE-AIM framework. If the intervention is proven effective, the study findings will be disseminated to promote scaling up to other similar settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of hypertension\n* Currently receiving/prescribed blood pressure-lowering medication for more than three month\n* With uncontrolled blood pressure (\\>140/90mm of Hg)\n* Should have access to a mobile phone\n* Able to read text messages ( by themselves/with the help of family)\n\nExclusion Criteria:\n\n* Diagnosed with myocardial infarction, stroke, and kidney failure\n* Severe mental illness, cognitive impairment\n* Pregnant women or in the postpartum period'}, 'identificationModule': {'nctId': 'NCT05979168', 'acronym': 'TelTex4BP', 'briefTitle': 'Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal', 'organization': {'class': 'OTHER', 'fullName': 'Central Department of Public Health'}, 'officialTitle': 'Effectiveness and Adoption of the Structured mHealth Intervention for Improving Blood Pressure Control (TelTex4BP) Among Adults With Hypertension in Nepal: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BLSCHP-2303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Hypertensive patients with uncontrolled BP in the intervention group will receive mobile phone text messages in the Nepali language and accept the phone call from the trained research nurse on their given mobile. They will also get the opportunity to ask questions and clarification during the phone call. However, text messaging would be only one way.', 'interventionNames': ['Behavioral: Phone call and text Messages']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'The control arm will receive the usual routine maintenance. In Nepal, hypertensive patients usually receive a prescription of antihypertensive medicine and advise for follow-up as the standard care. In addition, a pamphlet containing information about hypertension and required behavior modifications will be provided to all study participants, including the control arm.'}], 'interventions': [{'name': 'Phone call and text Messages', 'type': 'BEHAVIORAL', 'otherNames': ['TelTex4BP'], 'description': "The intervention consists of recommended lifestyle counselling (on a healthy diet, physical activity, smoking, alcohol intake, medication adherence and continuity of care). This counselling will be provided through the research nurse at baseline and for six months (tentative plan phone call once a month; frequency and duration will be finalized based on formative study) by calling on participants' given mobile numbers. In addition, text message reminders on the same topics will be delivered regularly (2-3 times a week) for six months. The counselling and message will focus on three domains of COM-B; capabilities needed, opportunities and practical tools, and motivation strategies informed by behaviour change techniques.", 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40660', 'city': 'Kathmandu', 'state': 'Pradesh 3 (Bagmati)', 'country': 'Nepal', 'contacts': [{'name': 'Dr Buna Bhandari, PhD', 'role': 'CONTACT', 'email': 'buna.bhandari@gmail.com', 'phone': '9851320990'}, {'name': 'Dr Pranil Man Singh Pradhan, MD', 'role': 'CONTACT', 'email': 'pranil.pradhan@gmail.com'}, {'name': 'Buna Bhandari Bhattarai', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pranil Man Singh Pradhan', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Central Department of Public Health', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}], 'centralContacts': [{'name': 'Buna Bhandari', 'role': 'CONTACT', 'email': 'buna.bhandari@gmail.com', 'phone': '9851320990'}, {'name': 'Pranil Man Singh Pradhan', 'role': 'CONTACT', 'email': 'pranil.pradhan@gmail.com'}], 'overallOfficials': [{'name': 'Buna Bhandari Bhattarai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Department of Public Health, Tribhuvan University Institue of Medicine Nepal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Department of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}