xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05979168</url>
    </required_header>
    <id_info>
      <org_study_id>BLSCHP-2303</org_study_id>
      <nct_id>NCT05979168</nct_id>
    </id_info>
    <brief_title>Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal</brief_title>
    <acronym>TelTex4BP</acronym>
    <official_title>Effectiveness and Adoption of the Structured mHealth Intervention for Improving Blood Pressure Control (TelTex4BP) Among Adults With Hypertension in Nepal: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Central Department of Public Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Harvard School of Public Health (HSPH)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Central Department of Public Health</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Despite evidence of preventing cardiovascular disease (CVD) risk through lifestyle changes,&#xD;
        many patients with hypertension (HTN) do not comply with this and suffer from CVD and other&#xD;
        complications. A previous study using a structured lifestyle intervention program has&#xD;
        reported a 14% decrease in the 10-year risk of developing CVD at one year among hypertensive&#xD;
        and diabetes patients. Low and Middle-Income countries (LMICs) struggle with a shortage of&#xD;
        health workers to deliver such interventions. In this context, mobile phones can contribute&#xD;
        to bridging this gap by incorporating them into the health system for health intervention&#xD;
        delivery. There is a need to develop contextual mHealth intervention adapted to local needs&#xD;
        and culture and test its effectiveness in LMIC settings like Nepal. Our previous small-scale&#xD;
        pilot mHealth (text messages) study reported promising evidence in reducing blood pressure&#xD;
        among hypertensive patients in the intervention arm [adjusted reduction in systolic blood&#xD;
        pressure (BP) -6.50 (95% CI, -12.6; -0.33) and diastolic BP -4.60 (95% CI, -8.16; -1.04)],&#xD;
        with a greater proportion achieving target BP (70% vs 48% in the control arm, p = 0.006)] and&#xD;
        improving treatment compliance (p &lt; 0.001) in Nepal. This finding supports the expansion to a&#xD;
        large-scale trial of a structured mHealth intervention to see its long-term effectiveness and&#xD;
        sustainability for patients with HTN to improve BP control and reduce CVD risk. Hence, this&#xD;
        study aims to assess the effectiveness of a behavioural intervention through mHealth&#xD;
        (telephone/mobile phone calls and text messages) informed by the RE-AIM framework for&#xD;
        improving blood pressure control among patients with hypertension in a hospital (Manamohan&#xD;
        Cardiothoracic Vascular and Transplant Center) of Kathmandu, Nepal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a hybrid type 2 effectiveness-implementation study using mixed methods, a&#xD;
        parallel randomized controlled trial with a nested qualitative design. The intervention will&#xD;
        be codesigned involving patients, their family members, and healthcare providers to&#xD;
        incorporate their views, the local context and culture through a formative qualitative&#xD;
        component informed by the COM-B model. A multi-component mHealth intervention will be&#xD;
        delivered through text messages and phone calls (TelTex4BP) by nurses, focusing on behaviour&#xD;
        changes (physical activity, healthy diet), medication adherence, a reminder for follow-up,&#xD;
        smoking, and alcohol intake. The intervention will be delivered for six months, and follow-up&#xD;
        will be carried out at the end of the intervention and six months later (at one year) to&#xD;
        assess sustainability and long-term effectiveness. Clinical (blood pressure, 10-year risk of&#xD;
        CVD), intermediate (medication adherence, change of dietary habits/physical activity), and&#xD;
        implementational outcomes ( Reach, Adoption, Intervention fidelity and Maintenance) will be&#xD;
        evaluated using the RE-AIM framework. If the intervention is proven effective, the study&#xD;
        findings will be disseminated to promote scaling up to other similar settings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>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.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Systolic Blood Pressure</measure>
      <time_frame>baseline, 6 and 12 months</time_frame>
      <description>Average of last of two measures of Blood pressure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood Pressure Control</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <description>Measures of Systolic and diastolic BP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>10 year risk of development of CVD</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <description>Globo CVD risk calculator</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication adherence</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary habits (salt intake, fruits and vegetables intake)</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <description>Dietary salt [9 items] based on the WHO STEPs survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Baseline, 6 and 12 months</time_frame>
      <description>Physical activity [17 items]based on the WHO STEPs survey</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Hypertension</condition>
    <condition>Medication Adherence</condition>
    <condition>Blood Pressure</condition>
    <condition>Cardiovascular Diseases</condition>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Phone call and text Messages</intervention_name>
      <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.</description>
      <arm_group_label>Intervention arm</arm_group_label>
      <other_name>TelTex4BP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of hypertension&#xD;
  &#xD;
            -  Currently receiving/prescribed blood pressure-lowering medication for more than three&#xD;
               month&#xD;
  &#xD;
            -  With uncontrolled blood pressure (&gt;140/90mm of Hg)&#xD;
  &#xD;
            -  Should have access to a mobile phone&#xD;
  &#xD;
            -  Able to read text messages ( by themselves/with the help of family)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with myocardial infarction, stroke, and kidney failure&#xD;
  &#xD;
            -  Severe mental illness, cognitive impairment&#xD;
  &#xD;
            -  Pregnant women or in the postpartum period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Buna Bhandari Bhattarai, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Central Department of Public Health, Tribhuvan University Institue of Medicine Nepal</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Buna Bhandari</last_name>
      <phone>9851320990</phone>
      <email>buna.bhandari@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pranil Man Singh Pradhan</last_name>
      <email>pranil.pradhan@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Central Department of Public Health</name>
        <address>
          <city>Kathmandu</city>
          <state>Pradesh 3 (Bagmati)</state>
          <zip>40660</zip>
          <country>Nepal</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Buna Bhandari, PhD</last_name>
        <phone>9851320990</phone>
        <email>buna.bhandari@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Dr Pranil Man Singh Pradhan, MD</last_name>
        <email>pranil.pradhan@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Buna Bhandari Bhattarai</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pranil Man Singh Pradhan</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Nepal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mobile Intervention</keyword>
    <keyword>Blood Pressure Control</keyword>
    <keyword>Hypertension</keyword>
    <keyword>Randomized Controlled Trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05979168
  org study id: BLSCHP-2303
  nct id: NCT05979168
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 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.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Systolic Blood Pressure
  time frame: baseline, 6 and 12 months
  description: Average of last of two measures of Blood pressure.
  measure: Blood Pressure Control
  time frame: Baseline, 6 and 12 months
  description: Measures of Systolic and diastolic BP
  measure: 10 year risk of development of CVD
  time frame: Baseline, 6 and 12 months
  description: Globo CVD risk calculator
  measure: Medication adherence
  time frame: 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)
  time frame: Baseline, 6 and 12 months
  description: Dietary salt [9 items] based on the WHO STEPs survey
  measure: Physical activity
  time frame: Baseline, 6 and 12 months
  description: Physical activity [17 items]based on the WHO STEPs survey
  arm group label: Intervention arm
  arm group type: Experimental
  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.
  arm group label: Control arm
  arm group type: No Intervention
  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.
  intervention type: Behavioral
  intervention name: Phone call and text Messages
  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.
  arm group label: Intervention arm
  other name: TelTex4BP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Buna Bhandari Bhattarai, PhD
  role: Principal Investigator
  affiliation: Central Department of Public Health, Tribhuvan University Institue of Medicine Nepal
  last name: Buna Bhandari
  phone: 9851320990
  email: buna.bhandari@gmail.com
  last name: Pranil Man Singh Pradhan
  email: pranil.pradhan@gmail.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Nepal
  responsible party type: Sponsor
  mesh term: Hypertension
  mesh term: Cardiovascular Diseases
  sharing ipd: No