<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/NCT04437966</url>
  </required_header>
  <id_info>
    <org_study_id>BLSCHP-2008</org_study_id>
    <nct_id>NCT04437966</nct_id>
  </id_info>
  <brief_title>Chronic Disease Self-management Program for Hypertension Control in Churches</brief_title>
  <acronym>CHIC</acronym>
  <official_title>Assessing Effectiveness of a Chronic Disease Self-management Program in Faith-based Organizations in Barbados: a Cluster Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of The West Indies</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>The University of The West Indies</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>
      In Barbados, levels of hypertension are high (40.7%) and cause of a high proportion of deaths&#xD;
      due to cardiovascular diseases. In this study, the Stanford University-led Chronic Disease&#xD;
      Self-Management Program (CDSMP) will be modified to form one of the basic components of a&#xD;
      three-pronged intervention to improve blood pressure control.&#xD;
&#xD;
      Our overall goal is to evaluate the effectiveness of a hypertension self-management program&#xD;
      in community-based settings. With the advent of the Coronavirus disease 2019 (COVID-19) we&#xD;
      recognize that it may be necessary to adapt the programme to accommodate virtual delivery.&#xD;
&#xD;
      Our specific aims are to:&#xD;
&#xD;
        1. Adapt the Stanford (CDSMP) to ensure cultural appropriateness to Barbados. In view of&#xD;
           the need to adhere to physical distance guidelines in the era of COVID-19 disease,&#xD;
           modifications will be made to enhance virtual delivery while maintaining programme&#xD;
           fidelity. We will engage stakeholders in performing modifications related to content,&#xD;
           context and mode of delivery of the CDSMP program with the goal of ensuring cultural&#xD;
           appropriateness.&#xD;
&#xD;
        2. Determine the clinical effectiveness of CDSMP combined with medication enhancement&#xD;
           tools. We will conduct a cluster randomized trial in twelve faith-based&#xD;
           organizations(FBOs) in Barbados. We are primarily interested in studying the changes in&#xD;
           systolic blood pressure. Secondarily, we will also assess change in weight, medication&#xD;
           adherence, dietary behavior and physical activity.&#xD;
&#xD;
        3. Understand the barriers and facilitators to implementation and sustainability of CDSMP&#xD;
           plus self-monitoring tools in faith-based organizations. We will assess cost and&#xD;
           sustainability of the intervention and qualitatively assess factors associated with&#xD;
           barriers and facilitators of implementation in FBOs in Barbados.&#xD;
&#xD;
      Impact and novelty: We aim to increase the proportion of patients with controlled&#xD;
      hypertension leading to reduced illness and deaths from strokes and heart attacks in&#xD;
      particular. Few studies have looked at a blended approach to CDSMP delivery and these will&#xD;
      become more necessary in the era of COVID-19. Findings on the factors impacting&#xD;
      implementation will be transferable to small island developing states and other predominantly&#xD;
      black populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Setting: This cluster randomized trial will be conducted among members of selected church&#xD;
      groups in Barbados - a small island developing state in the Caribbean with a population of&#xD;
      approximately 287 025 (52% female). According to the Barbados' 2010 census, approximately&#xD;
      three-quarters of the population identify as Christian. This study is intended for Christian&#xD;
      churches in Barbados, from any denomination. Barbados is divided into 11 parishes. Given the&#xD;
      small sizes of many churches in Barbados we have chosen to cluster by parish and divide the&#xD;
      most densely populated parish (St. Michael) into two divisions. This gives us a total of 12&#xD;
      geographic divisions. Each division consists of 7-9 of our target churches comprising a total&#xD;
      of about 350 members per division. The study will consider each division as a single unit&#xD;
      which will be randomized to either intervention or control. The treatment of a division as&#xD;
      one assembly allows the study to have sufficient participants at each recruitment event to be&#xD;
      able to meet the required sample size of persons with uncontrolled hypertension.&#xD;
&#xD;
      Recruitment: Potential participants will be invited to recruitment days where they are&#xD;
      screened for hypertension. All persons with a previous diagnosis of hypertension or currently&#xD;
      on anti-hypertensives AND the occurrence of two or more blood pressure readings above 140&#xD;
      mmHg (systolic) or 90mmHg (diastolic) on the day of recruitment will be deemed eligible.&#xD;
      Persons not known to have hypertension but who have two or more blood pressure readings above&#xD;
      140 mmHg (systolic) or 90mmHg (diastolic) on the day of recruitment are also eligible.&#xD;
&#xD;
      Clinical screening will also be conducted and persons will be included in the study if their&#xD;
      systolic blood pressure (SBP) and diastolic blood pressure (DBP) readings are greater than or&#xD;
      equal to 140 mmHg or 90 mmHg respectively on two or more readings taken at rest more than 5&#xD;
      minutes apart on the day of screening. Persons who are well controlled on blood pressure&#xD;
      lowering drugs will be excluded. To obtain eligible participants, fliers and information on&#xD;
      the study will be circulated on social media and via telephone. Recruitment days will be&#xD;
      conducted with strict physical distancing protocols in place which are in keeping with the&#xD;
      stage of restriction Barbados is experiencing at the time of recruitment. Recruitment will&#xD;
      not occur during times of day time curfew and will conform to government directives.&#xD;
&#xD;
      Randomization of the churches will occur after completion of all baseline assessments, and&#xD;
      the study statistician will randomly assign each church to either intervention or control&#xD;
      groups based on a 1:1 ratio, using a pre-specified random number generator (Stata statistical&#xD;
      software version 16). Using a 3-church block, we will assign 2 churches to intervention and 2&#xD;
      churches to control in each randomization block. Given the nature of the intervention, the&#xD;
      trial will not be blinded. However, data collectors will be blinded to church randomization&#xD;
      status until the end of the six-week recruitment period.&#xD;
&#xD;
      Sample size: Previous studies have found group mean SBP reductions ranging from 4.5 mmHg to&#xD;
      6.6 mm Hg17. Using the lowest group mean SBP reduction of 4.5 mmHg (SD 10)21 among the&#xD;
      persons living with uncontrolled hypertension and given a study of 12 clusters we estimated&#xD;
      that 168 persons in the intervention and 168 in the control group, would provide 80% power to&#xD;
      detect a difference of 4.5 mmHg. This is assuming an intra-class correlation (ICC) of 0.0517.&#xD;
      This required sample size of 336 provides us cluster sizes of 28. Given that CDSMP groups are&#xD;
      typically between 12-16 each, we will recruit 32 per cluster (church) for a total of 192&#xD;
      persons in intervention and control arms each and a total required sample size of 384.&#xD;
      Calculations were performed using Stata statistical software version 15.&#xD;
&#xD;
      Data collection (Described by aim) Aim 1: Adapt the Stanford CDSMP to ensure cultural&#xD;
      appropriateness to Barbados: A series of stakeholder engagement meetings will be held to&#xD;
      adapt the original lifestyle workshop series, Stanford CDSMP, so as to ensure it is&#xD;
      culturally relevant, appropriate, and sensitive to Caribbean and Caribbean-descent&#xD;
      populations. The Stirman et al model will be used to guide the adaptation process, allowing&#xD;
      us to systematically look at content, context, and training adaptations. Modifications will&#xD;
      be made to place an emphasis on medication adherence, hypertension self-management and use of&#xD;
      the Dietary Approaches to Stop Hypertension (DASH) diet given our focus on hypertension.&#xD;
      Foods and packaging commonly used in Barbados as well as the Caribbean Food and Nutrition&#xD;
      Pyramids will be highlighted in the nutrition aspect of the program.&#xD;
&#xD;
      Stakeholder engagement will include researchers, dieticians, clinicians and lay persons from&#xD;
      Barbados as well as CDSMP experts to ensure that fidelity to the essential components of the&#xD;
      program is maintained.&#xD;
&#xD;
      Aim 2: Determine the clinical effectiveness of CDSMP combined with medication adherence&#xD;
      tools: The intervention consists of three levels - (1) chronic disease self-management&#xD;
      workshops, (2) distribution of and teaching on the use of medication pill boxes and (3) use&#xD;
      of social media (WhatsApp version 2.0) to encourage medication adherence. We combine&#xD;
      previously tested CDSMP and add medication adherence tools and social media use to develop a&#xD;
      novel intervention focusing on improving patient self-efficacy to manage and make decisions&#xD;
      about their illness. The Stanford-based CDSMP minimizes traditional methods of didactic&#xD;
      knowledge transfer and focuses on enhancing skills through problem solving and brainstorming&#xD;
      activities. In the workshop series the following will be discussed: blood pressure control,&#xD;
      finding and affording healthy foods, label reading, physical activity, planning a healthy&#xD;
      plate, making traditional foods healthy and portion control. These workshops are based on the&#xD;
      Stanford Chronic Disease Self-Management Curriculum thus researchers will be trained as&#xD;
      workshop leaders. Controls will receive educational material at baseline and one didactic&#xD;
      session (on importance of medication adherence to hypertension control) lasting 1 hour&#xD;
      delivered by a health care professional. Medication adherence: Pill boxes will be distributed&#xD;
      to all individuals in the intervention group. Post workshop, participants will be sent twice&#xD;
      weekly reminders to use their high blood pressure medications via the social media tool&#xD;
      WhatsApp. These will be sent for a period of one month. Assessment of adherence to the&#xD;
      patient's baseline medication before randomisation will be done by measurement of home&#xD;
      systolic blood pressure 6 h after directly observed therapy and by returned tablet counts.&#xD;
      Blood pressure measurements only, will be repeated after the medication adherence segment.&#xD;
&#xD;
      During an interview at the FBO, data will be collected in the following domains: demographic&#xD;
      information (age, sex, ethnicity, education, income, address, telephone number); medication&#xD;
      use; primary and tertiary care visit frequency; behavioral risk factors (tobacco smoking,&#xD;
      alcohol consumption, physical inactivity, diet), medical history, place of treatment and&#xD;
      costs incurred. Anthropometric measurements and blood pressure will be completed. Global&#xD;
      Physical Activity questionnaire will be used as well as a food frequency questionnaire which&#xD;
      has already been modified for use in Barbados. Questionnaires will also be used to assess&#xD;
      self-efficacy. Immediately after the final workshop of the intervention, blood pressure,&#xD;
      weight, physical activity survey and food frequency survey assessments will be repeated. Each&#xD;
      control site will receive repeat measurements after the workshops are complete at the&#xD;
      geographically closest intervention site. At each intervention site and control site,&#xD;
      patients will be contacted six months after the first day of their workshop for repeat of&#xD;
      weight, blood pressure, dietary habits, physical activity, medication adherence and&#xD;
      self-efficacy. The mode of survey interviews will be face-to-face ideally. Participants will&#xD;
      be given an electronic device and assisted with completing the survey if necessary.&#xD;
      Participants will be given appointments to ensure that directives regarding the number of&#xD;
      persons in the room can be adhered to. This will decrease the contact with data&#xD;
      collectors/supporters. If however, directives from the government prevent face-to-face&#xD;
      interviews, surveys will be done virtually.&#xD;
&#xD;
      Workshops may have to be modified to be either partially or completely online to accommodate&#xD;
      physical distancing measures required by COVID-19 directives in place at the time of the&#xD;
      study.&#xD;
&#xD;
      Distribution of pill boxes Each participant will be given a pill box and taught how to use&#xD;
      these The combination of medication adherence reminders, tool box distribution and CDSMP is&#xD;
      novel Medication adherence reminders (mHealth) Planned use of an open source, web-based&#xD;
      social media platform (eg. WhatsApp) Others have used one-way tools like Short Message&#xD;
      Service (SMS) texting and custom-built apps. This method will allow a secondary assessment of&#xD;
      the impact of social interaction facilitated by WhatsApp&#xD;
&#xD;
      Aim 3: Understand the barriers and facilitators to implementation and sustainability of CDSMP&#xD;
      plus medication adherence tools in faith-based organizations: We will focus on evaluating the&#xD;
      implementation process by measuring fidelity, costs and sustainability. CDSMP trained master&#xD;
      trainers will attend at least two workshops in each series to measure the extent to which&#xD;
      workshop leaders successfully carried out the workshops as designed in Aim 1. We will track&#xD;
      the actual cost of workshop implementation including tools needed for delivery. We will use&#xD;
      the Program Sustainability Assessment Tool developed by the Center for Population Health&#xD;
      Sciences, Washington University(Appendix 4) and used by the Center for Disease Control and&#xD;
      Prevention. Leaders of the FBOs or their designate will undergo a virtual interview where&#xD;
      this tool will be used. Interviews will be audio recorded.&#xD;
&#xD;
      Data management, safety and confidentiality: All quantitative data will be collected using&#xD;
      Computer-Assisted Personal Interviews (CAPI), directly onto a tablet computer. The data&#xD;
      collection infrastructure will use REDCap (a secure web application for building and managing&#xD;
      online surveys and databases). While REDCap can be used to collect virtually any type of&#xD;
      data, it is specifically geared to support online and offline data capture for research&#xD;
      studies and operations. Quantitative data will be de-identified before being cleared for&#xD;
      analysis and analyzed data will be aggregated at all times. Data analysis: We will determine&#xD;
      the mean changes in SBP levels (primary endpoint) for the intervention group versus the&#xD;
      control and compare differences in outcomes using mixed effects regression models. This model&#xD;
      will allow for the effect of clustering on the precision of the estimates while allowing also&#xD;
      for adjustment of covariates. We will adopt the intention-to-treat principle to analyze the&#xD;
      data collected. Secondary outcomes will be assessed as follows: mean change in weight (kg)&#xD;
      will be compared between intervention and control groups after adjustment for covariates.&#xD;
      Changes in dietary behavior will be monitored by the calculation of the DASH diet score.&#xD;
      Physical activity will be measured by comparing the intervention group median physical&#xD;
      activity in MET-minutes per week. Self-efficacy scores will be calculated. Both primary and&#xD;
      secondary outcome measures will be performed pre-implementation, immediately post-workshop&#xD;
      and 6 months post-workshop. Quantitative assessment of fidelity and sustainability&#xD;
      assessments will be completed calculating proportion of organizations/workshops which adhere&#xD;
      to items on each tool. The semi-structured interviews conducted for aim 3 will be audio&#xD;
      recorded, transcribed verbatim and analyzed using thematic content analysis to allow themes&#xD;
      on facilitators and barriers of implementation to emerge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 11, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>Twelve faith based organizations will be chosen from an organization known as New Testament Church of God Assemblies (a Pentecostal religion). Of the 12 organizations selected to participate in the study, six will be randomized to receive the intervention and six will receive usual care. the study statistician will randomly assign each church to either intervention or control groups based on a 1:1 ratio, using a pre-specified random number generator (Stata statistical software version 16). Using a 3-church block, we will assign 2 churches to intervention and 2 churches to control in each randomization block. Block randomization will be used to ensure balanced distribution of intervention and control churches.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Data collectors will be blinded to church randomization status until the end of the six-week recruitment period.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>Six months</time_frame>
    <description>We will measure systolic blood pressure before and 6 months after the interventions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean weight change for intervention and control groups</measure>
    <time_frame>Six months</time_frame>
    <description>We will measure participants' weight in kilograms before and six months after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet</measure>
    <time_frame>Six months</time_frame>
    <description>Changes in dietary behavior will be monitored by using the Dietary Approaches to Stop Hypertension Accordance Score. Score ranges from 0 to 9. A low score represents a poor diet for hypertension control. The higher the score the more appropriate for hypertension control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing physical activity levels using the Global Physical Activity Questionnaire (GPAQ)</measure>
    <time_frame>Six months</time_frame>
    <description>Using the results of the Global Physical Activity Questionnaire median physical activity in MET-minutes per week will be calculated before the intervention as well as six months post intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy for Managing Chronic Diseases 6-item Scale</measure>
    <time_frame>Six months</time_frame>
    <description>Perceived self-efficacy scores will be calculated using a tool developed by K Lorig(Stanford University School of Medicine) for measuring self-efficacy in chronic disease management programs. Score ranges from 1 to 10. A higher score is better.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">384</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Self-management Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consists of three levels - (1) chronic disease self-management workshops, (2) distribution of and teaching on the use of medication pill boxes and (3) use of social media (WhatsApp version 2.0) to encourage medication adherence.&#xD;
We combine the Stanford Chronic Disease Self-Management Curriculum, add medication adherence tools and social media use to develop a novel intervention aimed at better blood pressure control. The CDSMP focuses on enhancing skills through problem solving and brainstorming activities. In the workshop we discuss: blood pressure control, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. Pill boxes will be distributed to all individuals in the intervention group. Post workshop, participants will be sent twice weekly reminders to use their high blood pressure medications via the social media tool WhatsApp. These will be sent for one month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Controls will receive educational material at baseline and one didactic session (on importance of medication adherence to hypertension control) lasting 1 hour delivered by a health care professional.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Chronic Disease Self-management program</intervention_name>
    <description>CDSMP workshops will last for approximately 2.5 hours and occur weekly for six weeks. Sessions will focus on appropriate diet for persons with hypertension and to facilitate weight loss; managing medications, adherence to medical clinic appointments; physical activity and stress management. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management program. Participants will also be given pill boxes and will be prompted by social media messages to make and keep clinic appointments as well as maintain a healthy lifestyle.</description>
    <arm_group_label>Self-management Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident in Barbados for the previous six months&#xD;
&#xD;
          -  No plans to migrate over the ensuing one year.&#xD;
&#xD;
          -  All persons with a previous diagnosis of hypertension or currently on anti-&#xD;
             hypertensives AND the occurrence of two or more blood pressure readings above 140 mmHg&#xD;
             (systolic) or 90mmHg (diastolic) on the day of recruitment will be deemed eligible.&#xD;
&#xD;
          -  Persons not known to have hypertension but who have two or more blood pressure&#xD;
             readings above 140 mmHg (systolic) or 90mmHg (diastolic) on the day of recruitment are&#xD;
             also eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-residents of Barbados&#xD;
&#xD;
          -  Persons whose systolic blood pressure is below 140mmHg AND/OR diastolic blood pressure&#xD;
             below 90mmHg&#xD;
&#xD;
          -  Persons who are pregnant of planning to become pregnant over the following nine months&#xD;
&#xD;
          -  Unwillingness/inability to comply with the study protocol&#xD;
&#xD;
          -  Current participation in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natasha P Sobers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Alleyne Chronic Disease Research Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Brathwaite-Graham, MPH</last_name>
    <role>Study Director</role>
    <affiliation>George Alleyne Chronic Disease Research Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natasha P Sobers, PhD</last_name>
    <phone>2464266416</phone>
    <email>natasha.sobers@cavehill.uwi.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ian Hambleton, PhD</last_name>
    <phone>2464266416</phone>
    <email>ian.hambleton@cavehill.uwi.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>George Alleyne Chronic Disease Research Centre</name>
      <address>
        <city>Bridgetown</city>
        <zip>BB15000</zip>
        <country>Barbados</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natasha Sobers, PhD</last_name>
      <phone>2464266416</phone>
      <email>natasha.sobers@cavehill.uwi.edu</email>
    </contact>
    <investigator>
      <last_name>Ian Hambleton, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simon Anderson, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Natasha Sobers, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Trevor Fergusson, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Barbados</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 20, 2021</last_update_submitted>
  <last_update_submitted_qc>June 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of The West Indies</investigator_affiliation>
    <investigator_full_name>Natasha Sobers</investigator_full_name>
    <investigator_title>Lecturer, Epidemiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) will be shared, with standard removal of identifiable information (list the variables) and with de-identification of all dates by random shifting.&#xD;
All IPD that underlie results in a publication will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>The data will become available two years after the study analysis is complete.</ipd_time_frame>
    <ipd_access_criteria>IPD will only be shared if the absolute number of participants is greater than 20. There will be grouping of variables (such as exact age) that may contribute to &quot;potential identifiability&quot; of participants. Researchers will be given the option of contact with PI to use original dataset for approved research purposes.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04437966
org study id: BLSCHP-2008
nct id: NCT04437966
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In Barbados, levels of hypertension are high (40.7%) and cause of a high proportion of deaths
      due to cardiovascular diseases. In this study, the Stanford University-led Chronic Disease
      Self-Management Program (CDSMP) will be modified to form one of the basic components of a
      three-pronged intervention to improve blood pressure control.

      Our overall goal is to evaluate the effectiveness of a hypertension self-management program
      in community-based settings. With the advent of the Coronavirus disease 2019 (COVID-19) we
      recognize that it may be necessary to adapt the programme to accommodate virtual delivery.

      Our specific aims are to:

        1. Adapt the Stanford (CDSMP) to ensure cultural appropriateness to Barbados. In view of
           the need to adhere to physical distance guidelines in the era of COVID-19 disease,
           modifications will be made to enhance virtual delivery while maintaining programme
           fidelity. We will engage stakeholders in performing modifications related to content,
           context and mode of delivery of the CDSMP program with the goal of ensuring cultural
           appropriateness.

        2. Determine the clinical effectiveness of CDSMP combined with medication enhancement
           tools. We will conduct a cluster randomized trial in twelve faith-based
           organizations(FBOs) in Barbados. We are primarily interested in studying the changes in
           systolic blood pressure. Secondarily, we will also assess change in weight, medication
           adherence, dietary behavior and physical activity.

        3. Understand the barriers and facilitators to implementation and sustainability of CDSMP
           plus self-monitoring tools in faith-based organizations. We will assess cost and
           sustainability of the intervention and qualitatively assess factors associated with
           barriers and facilitators of implementation in FBOs in Barbados.

      Impact and novelty: We aim to increase the proportion of patients with controlled
      hypertension leading to reduced illness and deaths from strokes and heart attacks in
      particular. Few studies have looked at a blended approach to CDSMP delivery and these will
      become more necessary in the era of COVID-19. Findings on the factors impacting
      implementation will be transferable to small island developing states and other predominantly
      black populations.
Setting: This cluster randomized trial will be conducted among members of selected church
      groups in Barbados - a small island developing state in the Caribbean with a population of
      approximately 287 025 (52% female). According to the Barbados' 2010 census, approximately
      three-quarters of the population identify as Christian. This study is intended for Christian
      churches in Barbados, from any denomination. Barbados is divided into 11 parishes. Given the
      small sizes of many churches in Barbados we have chosen to cluster by parish and divide the
      most densely populated parish (St. Michael) into two divisions. This gives us a total of 12
      geographic divisions. Each division consists of 7-9 of our target churches comprising a total
      of about 350 members per division. The study will consider each division as a single unit
      which will be randomized to either intervention or control. The treatment of a division as
      one assembly allows the study to have sufficient participants at each recruitment event to be
      able to meet the required sample size of persons with uncontrolled hypertension.

      Recruitment: Potential participants will be invited to recruitment days where they are
      screened for hypertension. All persons with a previous diagnosis of hypertension or currently
      on anti-hypertensives AND the occurrence of two or more blood pressure readings above 140
      mmHg (systolic) or 90mmHg (diastolic) on the day of recruitment will be deemed eligible.
      Persons not known to have hypertension but who have two or more blood pressure readings above
      140 mmHg (systolic) or 90mmHg (diastolic) on the day of recruitment are also eligible.

      Clinical screening will also be conducted and persons will be included in the study if their
      systolic blood pressure (SBP) and diastolic blood pressure (DBP) readings are greater than or
      equal to 140 mmHg or 90 mmHg respectively on two or more readings taken at rest more than 5
      minutes apart on the day of screening. Persons who are well controlled on blood pressure
      lowering drugs will be excluded. To obtain eligible participants, fliers and information on
      the study will be circulated on social media and via telephone. Recruitment days will be
      conducted with strict physical distancing protocols in place which are in keeping with the
      stage of restriction Barbados is experiencing at the time of recruitment. Recruitment will
      not occur during times of day time curfew and will conform to government directives.

      Randomization of the churches will occur after completion of all baseline assessments, and
      the study statistician will randomly assign each church to either intervention or control
      groups based on a 1:1 ratio, using a pre-specified random number generator (Stata statistical
      software version 16). Using a 3-church block, we will assign 2 churches to intervention and 2
      churches to control in each randomization block. Given the nature of the intervention, the
      trial will not be blinded. However, data collectors will be blinded to church randomization
      status until the end of the six-week recruitment period.

      Sample size: Previous studies have found group mean SBP reductions ranging from 4.5 mmHg to
      6.6 mm Hg17. Using the lowest group mean SBP reduction of 4.5 mmHg (SD 10)21 among the
      persons living with uncontrolled hypertension and given a study of 12 clusters we estimated
      that 168 persons in the intervention and 168 in the control group, would provide 80% power to
      detect a difference of 4.5 mmHg. This is assuming an intra-class correlation (ICC) of 0.0517.
      This required sample size of 336 provides us cluster sizes of 28. Given that CDSMP groups are
      typically between 12-16 each, we will recruit 32 per cluster (church) for a total of 192
      persons in intervention and control arms each and a total required sample size of 384.
      Calculations were performed using Stata statistical software version 15.

      Data collection (Described by aim) Aim 1: Adapt the Stanford CDSMP to ensure cultural
      appropriateness to Barbados: A series of stakeholder engagement meetings will be held to
      adapt the original lifestyle workshop series, Stanford CDSMP, so as to ensure it is
      culturally relevant, appropriate, and sensitive to Caribbean and Caribbean-descent
      populations. The Stirman et al model will be used to guide the adaptation process, allowing
      us to systematically look at content, context, and training adaptations. Modifications will
      be made to place an emphasis on medication adherence, hypertension self-management and use of
      the Dietary Approaches to Stop Hypertension (DASH) diet given our focus on hypertension.
      Foods and packaging commonly used in Barbados as well as the Caribbean Food and Nutrition
      Pyramids will be highlighted in the nutrition aspect of the program.

      Stakeholder engagement will include researchers, dieticians, clinicians and lay persons from
      Barbados as well as CDSMP experts to ensure that fidelity to the essential components of the
      program is maintained.

      Aim 2: Determine the clinical effectiveness of CDSMP combined with medication adherence
      tools: The intervention consists of three levels - (1) chronic disease self-management
      workshops, (2) distribution of and teaching on the use of medication pill boxes and (3) use
      of social media (WhatsApp version 2.0) to encourage medication adherence. We combine
      previously tested CDSMP and add medication adherence tools and social media use to develop a
      novel intervention focusing on improving patient self-efficacy to manage and make decisions
      about their illness. The Stanford-based CDSMP minimizes traditional methods of didactic
      knowledge transfer and focuses on enhancing skills through problem solving and brainstorming
      activities. In the workshop series the following will be discussed: blood pressure control,
      finding and affording healthy foods, label reading, physical activity, planning a healthy
      plate, making traditional foods healthy and portion control. These workshops are based on the
      Stanford Chronic Disease Self-Management Curriculum thus researchers will be trained as
      workshop leaders. Controls will receive educational material at baseline and one didactic
      session (on importance of medication adherence to hypertension control) lasting 1 hour
      delivered by a health care professional. Medication adherence: Pill boxes will be distributed
      to all individuals in the intervention group. Post workshop, participants will be sent twice
      weekly reminders to use their high blood pressure medications via the social media tool
      WhatsApp. These will be sent for a period of one month. Assessment of adherence to the
      patient's baseline medication before randomisation will be done by measurement of home
      systolic blood pressure 6 h after directly observed therapy and by returned tablet counts.
      Blood pressure measurements only, will be repeated after the medication adherence segment.

      During an interview at the FBO, data will be collected in the following domains: demographic
      information (age, sex, ethnicity, education, income, address, telephone number); medication
      use; primary and tertiary care visit frequency; behavioral risk factors (tobacco smoking,
      alcohol consumption, physical inactivity, diet), medical history, place of treatment and
      costs incurred. Anthropometric measurements and blood pressure will be completed. Global
      Physical Activity questionnaire will be used as well as a food frequency questionnaire which
      has already been modified for use in Barbados. Questionnaires will also be used to assess
      self-efficacy. Immediately after the final workshop of the intervention, blood pressure,
      weight, physical activity survey and food frequency survey assessments will be repeated. Each
      control site will receive repeat measurements after the workshops are complete at the
      geographically closest intervention site. At each intervention site and control site,
      patients will be contacted six months after the first day of their workshop for repeat of
      weight, blood pressure, dietary habits, physical activity, medication adherence and
      self-efficacy. The mode of survey interviews will be face-to-face ideally. Participants will
      be given an electronic device and assisted with completing the survey if necessary.
      Participants will be given appointments to ensure that directives regarding the number of
      persons in the room can be adhered to. This will decrease the contact with data
      collectors/supporters. If however, directives from the government prevent face-to-face
      interviews, surveys will be done virtually.

      Workshops may have to be modified to be either partially or completely online to accommodate
      physical distancing measures required by COVID-19 directives in place at the time of the
      study.

      Distribution of pill boxes Each participant will be given a pill box and taught how to use
      these The combination of medication adherence reminders, tool box distribution and CDSMP is
      novel Medication adherence reminders (mHealth) Planned use of an open source, web-based
      social media platform (eg. WhatsApp) Others have used one-way tools like Short Message
      Service (SMS) texting and custom-built apps. This method will allow a secondary assessment of
      the impact of social interaction facilitated by WhatsApp

      Aim 3: Understand the barriers and facilitators to implementation and sustainability of CDSMP
      plus medication adherence tools in faith-based organizations: We will focus on evaluating the
      implementation process by measuring fidelity, costs and sustainability. CDSMP trained master
      trainers will attend at least two workshops in each series to measure the extent to which
      workshop leaders successfully carried out the workshops as designed in Aim 1. We will track
      the actual cost of workshop implementation including tools needed for delivery. We will use
      the Program Sustainability Assessment Tool developed by the Center for Population Health
      Sciences, Washington University(Appendix 4) and used by the Center for Disease Control and
      Prevention. Leaders of the FBOs or their designate will undergo a virtual interview where
      this tool will be used. Interviews will be audio recorded.

      Data management, safety and confidentiality: All quantitative data will be collected using
      Computer-Assisted Personal Interviews (CAPI), directly onto a tablet computer. The data
      collection infrastructure will use REDCap (a secure web application for building and managing
      online surveys and databases). While REDCap can be used to collect virtually any type of
      data, it is specifically geared to support online and offline data capture for research
      studies and operations. Quantitative data will be de-identified before being cleared for
      analysis and analyzed data will be aggregated at all times. Data analysis: We will determine
      the mean changes in SBP levels (primary endpoint) for the intervention group versus the
      control and compare differences in outcomes using mixed effects regression models. This model
      will allow for the effect of clustering on the precision of the estimates while allowing also
      for adjustment of covariates. We will adopt the intention-to-treat principle to analyze the
      data collected. Secondary outcomes will be assessed as follows: mean change in weight (kg)
      will be compared between intervention and control groups after adjustment for covariates.
      Changes in dietary behavior will be monitored by the calculation of the DASH diet score.
      Physical activity will be measured by comparing the intervention group median physical
      activity in MET-minutes per week. Self-efficacy scores will be calculated. Both primary and
      secondary outcome measures will be performed pre-implementation, immediately post-workshop
      and 6 months post-workshop. Quantitative assessment of fidelity and sustainability
      assessments will be completed calculating proportion of organizations/workshops which adhere
      to items on each tool. The semi-structured interviews conducted for aim 3 will be audio
      recorded, transcribed verbatim and analyzed using thematic content analysis to allow themes
      on facilitators and barriers of implementation to emerge.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Twelve faith based organizations will be chosen from an organization known as New Testament Church of God Assemblies (a Pentecostal religion). Of the 12 organizations selected to participate in the study, six will be randomized to receive the intervention and six will receive usual care. the study statistician will randomly assign each church to either intervention or control groups based on a 1:1 ratio, using a pre-specified random number generator (Stata statistical software version 16). Using a 3-church block, we will assign 2 churches to intervention and 2 churches to control in each randomization block. Block randomization will be used to ensure balanced distribution of intervention and control churches.
primary purpose: Treatment
masking: None (Open Label)
masking description: Data collectors will be blinded to church randomization status until the end of the six-week recruitment period.
measure: Systolic blood pressure
time frame: Six months
description: We will measure systolic blood pressure before and 6 months after the interventions
measure: Mean weight change for intervention and control groups
time frame: Six months
description: We will measure participants' weight in kilograms before and six months after the intervention
measure: Level of adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet
time frame: Six months
description: Changes in dietary behavior will be monitored by using the Dietary Approaches to Stop Hypertension Accordance Score. Score ranges from 0 to 9. A low score represents a poor diet for hypertension control. The higher the score the more appropriate for hypertension control.
measure: Assessing physical activity levels using the Global Physical Activity Questionnaire (GPAQ)
time frame: Six months
description: Using the results of the Global Physical Activity Questionnaire median physical activity in MET-minutes per week will be calculated before the intervention as well as six months post intervention
measure: Self-Efficacy for Managing Chronic Diseases 6-item Scale
time frame: Six months
description: Perceived self-efficacy scores will be calculated using a tool developed by K Lorig(Stanford University School of Medicine) for measuring self-efficacy in chronic disease management programs. Score ranges from 1 to 10. A higher score is better.
arm group label: Self-management Group
arm group type: Experimental
description: The intervention consists of three levels - (1) chronic disease self-management workshops, (2) distribution of and teaching on the use of medication pill boxes and (3) use of social media (WhatsApp version 2.0) to encourage medication adherence.
We combine the Stanford Chronic Disease Self-Management Curriculum, add medication adherence tools and social media use to develop a novel intervention aimed at better blood pressure control. The CDSMP focuses on enhancing skills through problem solving and brainstorming activities. In the workshop we discuss: blood pressure control, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. Pill boxes will be distributed to all individuals in the intervention group. Post workshop, participants will be sent twice weekly reminders to use their high blood pressure medications via the social media tool WhatsApp. These will be sent for one month.
arm group label: Usual care group
arm group type: No Intervention
description: Controls will receive educational material at baseline and one didactic session (on importance of medication adherence to hypertension control) lasting 1 hour delivered by a health care professional.
intervention type: Behavioral
intervention name: Enhanced Chronic Disease Self-management program
description: CDSMP workshops will last for approximately 2.5 hours and occur weekly for six weeks. Sessions will focus on appropriate diet for persons with hypertension and to facilitate weight loss; managing medications, adherence to medical clinic appointments; physical activity and stress management. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management program. Participants will also be given pill boxes and will be prompted by social media messages to make and keep clinic appointments as well as maintain a healthy lifestyle.
arm group label: Self-management Group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: No
last name: Natasha P Sobers, PhD
role: Principal Investigator
affiliation: George Alleyne Chronic Disease Research Centre
last name: Lisa Brathwaite-Graham, MPH
role: Study Director
affiliation: George Alleyne Chronic Disease Research Centre
last name: Natasha P Sobers, PhD
phone: 2464266416
email: natasha.sobers@cavehill.uwi.edu
last name: Ian Hambleton, PhD
phone: 2464266416
email: ian.hambleton@cavehill.uwi.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Barbados
responsible party type: Principal Investigator
investigator affiliation: The University of The West Indies
investigator full name: Natasha Sobers
investigator title: Lecturer, Epidemiology
mesh term: Hypertension
mesh term: Chronic Disease
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) will be shared, with standard removal of identifiable information (list the variables) and with de-identification of all dates by random shifting.
All IPD that underlie results in a publication will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: The data will become available two years after the study analysis is complete.
ipd access criteria: IPD will only be shared if the absolute number of participants is greater than 20. There will be grouping of variables (such as exact age) that may contribute to "potential identifiability" of participants. Researchers will be given the option of contact with PI to use original dataset for approved research purposes.