<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/NCT03772509</url>
  </required_header>
  <id_info>
    <org_study_id>00007318-5</org_study_id>
    <nct_id>NCT03772509</nct_id>
  </id_info>
  <brief_title>Use of Introduction Mode to Improve Interactive Voice Response Surveys in Bangladesh and Tanzania</brief_title>
  <official_title>A Randomized Controlled Trial of Varying Introduction Mode to Improve Interactive Voice Response (IVR) Survey Performance in Bangladesh and Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Bloomberg Family Foundation, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Epidemiology, Disease Control and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</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>
      This study evaluates the effect of two different introduction modes on interactive voice&#xD;
      response (IVR) survey cooperation, response, refusal, and contact rates, in Bangladesh and&#xD;
      Tanzania.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using random digit dialing (RDD) sampling techniques, participants were randomized to one of&#xD;
      two introduction modes, followed by a noncommunicable disease (NCD) risk factor survey. The&#xD;
      two modes were computer assisted telephone interview (CATI), in which a call-center employee&#xD;
      read the introduction to a participant and received oral consent from them, before sending&#xD;
      them the NCD risk factor survey via IVR, or the entire survey, including the introduction and&#xD;
      consent, being obtained via IVR. In IVR surveys, participants use their touch tone key pad to&#xD;
      answer pre-recorded questions. (i.e. If you are male, press 1; If you are female, press 2).&#xD;
      This study was conducted in both Bangladesh and Tanzania.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2017</start_date>
  <completion_date type="Actual">August 18, 2017</completion_date>
  <primary_completion_date type="Actual">August 18, 2017</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>Participants were randomized to one of two introduction and consent modes: 1) computer-assisted telephone interviews, or 2) interactive voice response.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cooperation Rate #1</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, cooperation rate is defined as I/(I+P+R) where I is complete interviews, P is partial interviews, and R is refusals and breakoffs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response Rate #4</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, response rate is defined as (I+P)/(I+P+R+eU) where I is complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Refusal Rate #2</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, refusal rate is defined as (R)/(I+P+R+eU) where R is refusals and breakoffs, I is complete interviews, P is partial interviews, and eU is the estimated eligible proportion of unknowns.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contact Rate #2</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, contact rate is defined as (I+P+R)/(I+P+R+eU) where I is complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1511</enrollment>
  <condition>Surveys and Questionnaires</condition>
  <condition>Noncommunicable Diseases</condition>
  <arm_group>
    <arm_group_label>CATI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Introduction and consent via computer assisted telephone interview</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IVR</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Introduction and consent via interactive voice response</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CATI</intervention_name>
    <description>The participants in this arm were read the introduction and asked for consent by a call center employee using computer-assisted telephone interviewing and then were sent a noncommunicable disease risk factor survey via interactive voice response. This mode was used to motivate participants to complete the survey.</description>
    <arm_group_label>CATI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Access to a mobile phone&#xD;
&#xD;
          -  Greater or equal to 18 years of age&#xD;
&#xD;
          -  In Bangladesh, conversant in either English or Bangla language. In Uganda, conversant&#xD;
             in either Luo, Luganda, Runyakitara, or English languages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adnan A Hyder, PhD, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George W. Pariyo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Epidemiology Disease Control and Research</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ifakara Health Institute</name>
      <address>
        <city>Dar Es Salaam</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
    <country>Tanzania</country>
  </location_countries>
  <reference>
    <citation>Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.</citation>
    <PMID>28476729</PMID>
  </reference>
  <reference>
    <citation>Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.</citation>
    <PMID>28476725</PMID>
  </reference>
  <reference>
    <citation>Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.</citation>
    <PMID>28476724</PMID>
  </reference>
  <reference>
    <citation>Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.</citation>
    <PMID>28476722</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mobile phone surveys</keyword>
  <keyword>interactive voice response</keyword>
  <keyword>computer-assisted telephone interviews</keyword>
  <keyword>introduction mode</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Noncommunicable 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>


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/NCT03772509
org study id: 00007318-5
nct id: NCT03772509
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of two different introduction modes on interactive voice
      response (IVR) survey cooperation, response, refusal, and contact rates, in Bangladesh and
      Tanzania.
Using random digit dialing (RDD) sampling techniques, participants were randomized to one of
      two introduction modes, followed by a noncommunicable disease (NCD) risk factor survey. The
      two modes were computer assisted telephone interview (CATI), in which a call-center employee
      read the introduction to a participant and received oral consent from them, before sending
      them the NCD risk factor survey via IVR, or the entire survey, including the introduction and
      consent, being obtained via IVR. In IVR surveys, participants use their touch tone key pad to
      answer pre-recorded questions. (i.e. If you are male, press 1; If you are female, press 2).
      This study was conducted in both Bangladesh and Tanzania.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized to one of two introduction and consent modes: 1) computer-assisted telephone interviews, or 2) interactive voice response.
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Cooperation Rate #1
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, cooperation rate is defined as I/(I+P+R) where I is complete interviews, P is partial interviews, and R is refusals and breakoffs.
measure: Response Rate #4
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, response rate is defined as (I+P)/(I+P+R+eU) where I is complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
measure: Refusal Rate #2
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, refusal rate is defined as (R)/(I+P+R+eU) where R is refusals and breakoffs, I is complete interviews, P is partial interviews, and eU is the estimated eligible proportion of unknowns.
measure: Contact Rate #2
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, contact rate is defined as (I+P+R)/(I+P+R+eU) where I is complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns.
arm group label: CATI
arm group type: Experimental
description: Introduction and consent via computer assisted telephone interview
arm group label: IVR
arm group type: No Intervention
description: Introduction and consent via interactive voice response
intervention type: Other
intervention name: CATI
description: The participants in this arm were read the introduction and asked for consent by a call center employee using computer-assisted telephone interviewing and then were sent a noncommunicable disease risk factor survey via interactive voice response. This mode was used to motivate participants to complete the survey.
arm group label: CATI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adnan A Hyder, PhD, MBBS
role: Principal Investigator
affiliation: Johns Hopkins University Bloomberg School of Public Health
last name: George W. Pariyo, PhD
role: Principal Investigator
affiliation: Johns Hopkins University Bloomberg School of Public Health
facility: 
facility: 
country: Bangladesh
country: Tanzania
citation: Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.
PMID: 28476729
citation: Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.
PMID: 28476725
citation: Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.
PMID: 28476724
citation: Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.
PMID: 28476722
responsible party type: Sponsor
mesh term: Noncommunicable Diseases
sharing ipd: No