<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/NCT03300154</url>
  </required_header>
  <id_info>
    <org_study_id>AR-T1087-P0001/2</org_study_id>
    <nct_id>NCT03300154</nct_id>
  </id_info>
  <brief_title>Effectiveness of Financial Incentives and Text Messages to Improve Health Care in Population With Moderate and High Cardiovascular Risk</brief_title>
  <official_title>Effectiveness of Financial Incentives and Text Messages to Improve Health Care of Vulnerable Population With Moderate and High Cardiovascular Risk in Argentina: A Randomized Cluster Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical Effectiveness and Health Policy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Inter-American Development Bank</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Clinical Effectiveness and Health Policy</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>
      Cardiovascular diseases are increasing throughout the developing world and are the cause of&#xD;
      almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries.&#xD;
      As more than three fourth of the global burden of cardiometabolic diseases are related to&#xD;
      risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low&#xD;
      physical activity, and harmful consumption of alcohol. This burden could be dramatically&#xD;
      reduced by changing individual behaviors. This study is focused on interventions that are&#xD;
      aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based&#xD;
      on a Behavioral Economics approach. Most of public policies targeted to tackle NCDs utilize a&#xD;
      rational economic model of behavior. Behavioral economics, by using insights from cognitive&#xD;
      psychology and other social sciences, has drawn a lot of attention for its potential to&#xD;
      increase healthy behaviors. Interventions informed by BE principles seek to rearrange the&#xD;
      social or physical environment in such a way to 'nudge' people towards healthier choices and&#xD;
      behaviors.&#xD;
&#xD;
      Main objective: to assess whether the implementation of two strategies based on behavioral&#xD;
      economics, that include the use of a financial incentive scheme and specific framing to&#xD;
      beneficiaries (i.e. mobile health interventions), increase the referral, evaluation and&#xD;
      follow-up of people with moderate and high cardiovascular risk in the public health network,&#xD;
      compared to the usual strategy.&#xD;
&#xD;
      Design: A cluster-randomized pragmatic clinical trial will be performed. The randomization&#xD;
      unit will be the Community Health Centers (CHC) and the intervention groups (2 arms) or&#xD;
      control will be assigned to 9 health centers in total (3 CHC per arm).&#xD;
&#xD;
      Population: This RCT is going to be conducted in selected CHC of Salta. Nine CHC will be&#xD;
      selected, which will be randomized: 3 centers to the control, 3 centers to framing&#xD;
      intervention with messages and 3 centers to the intervention with incentives.&#xD;
&#xD;
      A total of 900 patients ≥ 40 years, without health coverage and with a 10-year cardiovascular&#xD;
      risk ≥ 10% will participate in this study.&#xD;
&#xD;
      Follow up: 3 month&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 27, 2017</start_date>
  <completion_date type="Anticipated">October 23, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attendance at the first medical visit</measure>
    <time_frame>4 weeks</time_frame>
    <description>Proportion of patients who attended and completed the first clinical visit to the health center</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attendance at the second medical visit</measure>
    <time_frame>8 weeks after first medical visit</time_frame>
    <description>Proportion of patients who attended and completed the second clinical visit to the health center</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attendance at least one clinical visit</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of patients who attended and completed at least one clinical visit to the health</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">917</enrollment>
  <condition>Moderate and High Cardiovascular Risk</condition>
  <arm_group>
    <arm_group_label>Financial incentives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Framing (SMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial incentives</intervention_name>
    <description>The study nurses will schedule an appointment with the doctor at the health center, within 4 weeks from the participant's inclusion in the study. Participants who attend the first visit at the health center will receive a direct incentive consisting of the payment of a limited amount to be determined (approximately AR $ 150-200) through a shopping voucher for the amount mentioned. Participants attending the follow-up visit at the health center within 3 months from their inclusion in the study will participate in a lottery. The lottery will offer the possibility of winning a new voucher with a probability of 1 in 3. Participants who do not attend the health center will not receive any incentive.</description>
    <arm_group_label>Financial incentives</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Framing (SMS)</intervention_name>
    <description>After inclusion, participants will receive weekly text messages (SMS) using a specific framing or formulation of the message, highlighting the potential benefits and positive aspects of health care. These messages will promote follow-up visits, adherence to treatment, and benefits to be gained from a follow-up visit with the physician. Messages will be sent with a frequency of two per week during the first 30 days and then 1 per week until the end of the follow-up. These messages will have no cost to participants.</description>
    <arm_group_label>Framing (SMS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects that only have public health coverage.&#xD;
&#xD;
          -  Residence in the area of influence of the health centers of the study.&#xD;
&#xD;
          -  Have a mobile phone for personal use.&#xD;
&#xD;
          -  10 year cardiovascular risk ≥ 10%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Immobilized people.&#xD;
&#xD;
          -  Persons who do not give their informed consent.&#xD;
&#xD;
          -  People planning to move in the next 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>1º DE MAYO</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barrio Cooperativa</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barrio La Tablada</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Campo Santo</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIC</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EL BORDO</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>El cruce</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Villa Tranquila</name>
      <address>
        <city>Guemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Olivos</name>
      <address>
        <city>Güemes</city>
        <state>Salta</state>
        <zip>4400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiovascular risk</keyword>
  <keyword>Behavioral economics</keyword>
  <keyword>Text messages</keyword>
  <keyword>Financial incentives</keyword>
  <!-- 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/NCT03300154
org study id: AR-T1087-P0001/2
nct id: NCT03300154
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular diseases are increasing throughout the developing world and are the cause of
      almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries.
      As more than three fourth of the global burden of cardiometabolic diseases are related to
      risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low
      physical activity, and harmful consumption of alcohol. This burden could be dramatically
      reduced by changing individual behaviors. This study is focused on interventions that are
      aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based
      on a Behavioral Economics approach. Most of public policies targeted to tackle NCDs utilize a
      rational economic model of behavior. Behavioral economics, by using insights from cognitive
      psychology and other social sciences, has drawn a lot of attention for its potential to
      increase healthy behaviors. Interventions informed by BE principles seek to rearrange the
      social or physical environment in such a way to 'nudge' people towards healthier choices and
      behaviors.

      Main objective: to assess whether the implementation of two strategies based on behavioral
      economics, that include the use of a financial incentive scheme and specific framing to
      beneficiaries (i.e. mobile health interventions), increase the referral, evaluation and
      follow-up of people with moderate and high cardiovascular risk in the public health network,
      compared to the usual strategy.

      Design: A cluster-randomized pragmatic clinical trial will be performed. The randomization
      unit will be the Community Health Centers (CHC) and the intervention groups (2 arms) or
      control will be assigned to 9 health centers in total (3 CHC per arm).

      Population: This RCT is going to be conducted in selected CHC of Salta. Nine CHC will be
      selected, which will be randomized: 3 centers to the control, 3 centers to framing
      intervention with messages and 3 centers to the intervention with incentives.

      A total of 900 patients ≥ 40 years, without health coverage and with a 10-year cardiovascular
      risk ≥ 10% will participate in this study.

      Follow up: 3 month
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Attendance at the first medical visit
time frame: 4 weeks
description: Proportion of patients who attended and completed the first clinical visit to the health center
measure: Attendance at the second medical visit
time frame: 8 weeks after first medical visit
description: Proportion of patients who attended and completed the second clinical visit to the health center
measure: Attendance at least one clinical visit
time frame: 12 weeks
description: Proportion of patients who attended and completed at least one clinical visit to the health
arm group label: Financial incentives
arm group type: Experimental
arm group label: Framing (SMS)
arm group type: Experimental
arm group label: Usual care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Financial incentives
description: The study nurses will schedule an appointment with the doctor at the health center, within 4 weeks from the participant's inclusion in the study. Participants who attend the first visit at the health center will receive a direct incentive consisting of the payment of a limited amount to be determined (approximately AR $ 150-200) through a shopping voucher for the amount mentioned. Participants attending the follow-up visit at the health center within 3 months from their inclusion in the study will participate in a lottery. The lottery will offer the possibility of winning a new voucher with a probability of 1 in 3. Participants who do not attend the health center will not receive any incentive.
arm group label: Financial incentives
intervention type: Behavioral
intervention name: Framing (SMS)
description: After inclusion, participants will receive weekly text messages (SMS) using a specific framing or formulation of the message, highlighting the potential benefits and positive aspects of health care. These messages will promote follow-up visits, adherence to treatment, and benefits to be gained from a follow-up visit with the physician. Messages will be sent with a frequency of two per week during the first 30 days and then 1 per week until the end of the follow-up. These messages will have no cost to participants.
arm group label: Framing (SMS)
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
responsible party type: Sponsor