<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/NCT04506931</url>
  </required_header>
  <id_info>
    <org_study_id>00007318 - xyz</org_study_id>
    <nct_id>NCT04506931</nct_id>
  </id_info>
  <brief_title>Comparison of SMS, IVR, and CATI Surveys in Colombia</brief_title>
  <official_title>Comparison of Short Message Service (SMS), Interactive Voice Response (IVR), and Computer Assisted Telephone Interview (CATI) Mobile Phone Surveys for Non-communicable Disease Risk Factor Surveillance in Colombia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pontificia Universidad Javeriana</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>
      The objective of the study is to adapt and assess the feasibility, quality, and validity of&#xD;
      short message service or 'text message' (SMS), interactive voice response (IVR), and computer&#xD;
      assisted telephone interviews (CATI) for collecting information on noncommunicable disease&#xD;
      (NCD) risk factors&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to&#xD;
      one of the three arms: 1) SMS or 2) IVR or 3) CATI. Participants in the first study arm will&#xD;
      receive an SMS survey. Participants in the second study arm will receive a IVR survey.&#xD;
      Participants in the third study arm will receive a CATI survey. The IVR, SMS and CATI&#xD;
      questionnaires contain a set of demographic questions and one NCD module (alcohol, or&#xD;
      tobacco, or diet, or physical activity, or blood pressure and diabetes). The investigators&#xD;
      will examine contact, response, refusal and cooperation rates and demographic&#xD;
      representativeness by each study arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2021</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Participants were randomized to one of three mobile phone survey modalities: 1) SMS; 2) IVR; 3) CATI.</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 the number of participants with complete interviews, P is the number of participants with partial interviews, and R is the number of participants with 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 the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with 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 the number of participants with refusals and breakoffs, I is the number of participants with complete interviews, P is the number of participants with 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 the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5676</enrollment>
  <condition>Surveys and Questionnaires</condition>
  <condition>Noncommunicable Diseases</condition>
  <arm_group>
    <arm_group_label>Short Message Service (SMS) survey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an SMS survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interactive Voice Response (IVR) survey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an IVR survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computer Assisted Telephone Interviews (CATI) survey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a CATI survey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS Survey</intervention_name>
    <description>Participants will receive a SMS survey</description>
    <arm_group_label>Short Message Service (SMS) survey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IVR Survey</intervention_name>
    <description>Participants will receive an IVR survey</description>
    <arm_group_label>Interactive Voice Response (IVR) survey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CATI Survey</intervention_name>
    <description>Participants will receive a CATI survey</description>
    <arm_group_label>Computer Assisted Telephone Interviews (CATI) survey</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 Colombia, conversant in the Spanish language&#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>Dustin Gibson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angelica T Quinterro, PhD, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pontificia Universidad Javeriana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pontificia Universidad Javeriana</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</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>April 2022</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</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 interview</keyword>
  <keyword>short message service</keyword>
  <keyword>non-communicable diseases</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/NCT04506931
org study id: 00007318 - xyz
nct id: NCT04506931
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to adapt and assess the feasibility, quality, and validity of
      short message service or 'text message' (SMS), interactive voice response (IVR), and computer
      assisted telephone interviews (CATI) for collecting information on noncommunicable disease
      (NCD) risk factors
Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to
      one of the three arms: 1) SMS or 2) IVR or 3) CATI. Participants in the first study arm will
      receive an SMS survey. Participants in the second study arm will receive a IVR survey.
      Participants in the third study arm will receive a CATI survey. The IVR, SMS and CATI
      questionnaires contain a set of demographic questions and one NCD module (alcohol, or
      tobacco, or diet, or physical activity, or blood pressure and diabetes). The investigators
      will examine contact, response, refusal and cooperation rates and demographic
      representativeness by each study arm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized to one of three mobile phone survey modalities: 1) SMS; 2) IVR; 3) CATI.
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 the number of participants with complete interviews, P is the number of participants with partial interviews, and R is the number of participants with 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 the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with 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 the number of participants with refusals and breakoffs, I is the number of participants with complete interviews, P is the number of participants with 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 the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
arm group label: Short Message Service (SMS) survey
arm group type: Experimental
description: Participants will receive an SMS survey
arm group label: Interactive Voice Response (IVR) survey
arm group type: Experimental
description: Participants will receive an IVR survey
arm group label: Computer Assisted Telephone Interviews (CATI) survey
arm group type: Experimental
description: Participants will receive a CATI survey
intervention type: Other
intervention name: SMS Survey
description: Participants will receive a SMS survey
arm group label: Short Message Service (SMS) survey
intervention type: Other
intervention name: IVR Survey
description: Participants will receive an IVR survey
arm group label: Interactive Voice Response (IVR) survey
intervention type: Other
intervention name: CATI Survey
description: Participants will receive a CATI survey
arm group label: Computer Assisted Telephone Interviews (CATI) survey
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dustin Gibson, PhD
role: Principal Investigator
affiliation: Johns Hopkins University Bloomberg School of Public Health
last name: Angelica T Quinterro, PhD, MD, MSc
role: Principal Investigator
affiliation: Pontificia Universidad Javeriana
facility: 
country: Colombia
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