<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/NCT02975648</url>
  </required_header>
  <id_info>
    <org_study_id>51805715.0.0000.5393</org_study_id>
    <nct_id>NCT02975648</nct_id>
  </id_info>
  <brief_title>Educational Model for Cardiac Patients</brief_title>
  <official_title>Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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 purpose of this study was to compare the effect of an educational model, which included&#xD;
      cardiac rehabilitation with emphasis on physical activity and telephone follow up, with the&#xD;
      usual management of individuals undergoing to first percutaneous coronary intervention, in&#xD;
      relation to physical activity five until seven months after discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled trial (RCT) at a public teaching hospital, which has specialized care&#xD;
      for CAD in Ribeirão Preto, state of São Paulo, Brazil. The intervention group received usual&#xD;
      care and an educational programme and the control group received only usual care.&#xD;
&#xD;
      A researcher (who didn't had contact with the patients) generated the random allocation in&#xD;
      SPSS software, concealing it from the investigators in sequentially numbered, sealed and&#xD;
      opaque envelopes.&#xD;
&#xD;
      Another researcher performed the individual interview with each participant (baseline) and&#xD;
      aplied the instruments of socialdemographic data, physical activity, ansiety and depression,&#xD;
      perceived health status and selfefficacy to practice of physical activity. At the end of the&#xD;
      interviewThe same researcher opened the envelope to allocate the participants to either&#xD;
      intervention or control group. The participants of intervention group remained with the&#xD;
      researcher to receive the intervention.&#xD;
&#xD;
      The educational programme consisted of four booklets entitled 1. Percutaneous Transluminal&#xD;
      Coronary Angioplasty, 2. Going home after your coronary angioplasty, 3. How to take care of&#xD;
      your heart and your health, and 4. How to practice physical activities. The educational&#xD;
      programme included the telephone follow-up that contained three calls to motivate the&#xD;
      participants to change their lifestyle and clarify doubts. The contents of the booklets were&#xD;
      explained step by step to the participants by the researcher who conducted the interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical activity level from baseline to five to seven months</measure>
    <time_frame>baseline and five to seven months</time_frame>
    <description>The &quot;Baecke Questionnaire of Habitual Physical Activity&quot; was developed by Baecke, Burema and Frijters (1982) and validated for the Brazilian population by Florindo et al. (2004, 2006). The instrument has three dimensions: occupational physical activity (eight questions), physical activity during leisure time (four questions) and leisure and locomotion activities (four questions), totaling 16 questions. Higher scores indicate a higher level of physical activity. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in symptoms of anxiety and depression from baseline to five to seven months</measure>
    <time_frame>baseline and five to seven months</time_frame>
    <description>The questionnaire &quot;Hospital Anxiety and Depression Scale&quot; was developed by Zigmond and Snaith (1983) and validated and adapted to Portuguese by Botega et al. (1995). The Hospital Anxiety and Depression Scale contains 14 multiple choice questions, divided into two subscales: anxiety and depression (composed of seven items each). Higher scores indicate more symptoms of anxiety and depression. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived health status from baseline to five to seven months</measure>
    <time_frame>baseline and five to seven months</time_frame>
    <description>The questionnaire &quot;Medical Outcomes Survey 36 - Item Short-Form&quot; developed by Ware and Sherboune (1992). The investigators used the version licensed by Quality Metric Incorporated (MARUISH, 2011) for use in surveys in Brazil. The Medical Outcomes Survey 36 - Item Short-Form is a multidimensional questionnaire composed of 36 items that evaluate eight health concepts: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental health and a comparative question that evaluate the current health conditions with one year ago. Higher values indicate better perceived health status. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy for physical activity from baseline to five to seven months</measure>
    <time_frame>baseline and five to seven months</time_frame>
    <description>The questionnaire &quot;Escala de Autoeficácia Para Prática de Atividade Física&quot; developed by Rech et al. (2011) for Brazilian adults and by Borges et al. (2015) that used in the elderly population. This questionnaire was elaborated from two specific scales of self-efficacy for the practice of physical exercise, proposed by Sallis et al. (1988) and Bandura (2006). We used the Brazilian adult version (RECH et al., 2011) which contains two domains with five items each in which the answers are dichotomous ( &quot;no&quot; versus &quot;yes&quot;). Higher scores indicate better self-efficacy for physical activity. The instrument was used to collect the data at baseline and five to seven months after hospital discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Disease</condition>
  <condition>Arteriosclerosis</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At discharge, paticipants received guidance from health professionals. The paticipants had a medical return five to seven months after the percutaneous coronary intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational model + follow up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The paticipants received the hospital's instructions at discharge and participated in the educational program (booklets with telephone follow-up). The paticipants had a medical return five to seven months after discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>educational model + follow up</intervention_name>
    <description>Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)</description>
    <arm_group_label>Educational model + follow up</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>Hospital health professionals offered orientation on care after discharge</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18 years or more) of both genders&#xD;
&#xD;
          -  Patients undergoing the first percutaneous coronary intervention&#xD;
&#xD;
          -  Patients who had a properly functioning home phone line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No cognitive conditions to participate (assessed by the ability to inform the name,&#xD;
             current date, day of the week, place, age and place of birth confirmed by the&#xD;
             participant's identification document)&#xD;
&#xD;
          -  Who did not have clinical or physical conditions to answer the questionnaires&#xD;
             (individuals with dyspnea and / or mental confusion)&#xD;
&#xD;
          -  Who reported difficulties to speak on the phone (hearing loss)&#xD;
&#xD;
          -  Who had sequelae that could influence activities of daily living (limb amputation or&#xD;
             paralysis)&#xD;
&#xD;
          -  Who had a contraindication to physical exercise, prescribed by the doctor, and who&#xD;
             already participated in a supervised cardiac rehabilitation program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lidia A Rossi, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of São Paulo at Ribeirão Preto College of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>São Paulo</state>
        <zip>14040-902</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Natássia Condilo Pitta</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Arteriosclerosis</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/NCT02975648
org study id: 51805715.0.0000.5393
nct id: NCT02975648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to compare the effect of an educational model, which included
      cardiac rehabilitation with emphasis on physical activity and telephone follow up, with the
      usual management of individuals undergoing to first percutaneous coronary intervention, in
      relation to physical activity five until seven months after discharge.
Randomized controlled trial (RCT) at a public teaching hospital, which has specialized care
      for CAD in Ribeirão Preto, state of São Paulo, Brazil. The intervention group received usual
      care and an educational programme and the control group received only usual care.

      A researcher (who didn't had contact with the patients) generated the random allocation in
      SPSS software, concealing it from the investigators in sequentially numbered, sealed and
      opaque envelopes.

      Another researcher performed the individual interview with each participant (baseline) and
      aplied the instruments of socialdemographic data, physical activity, ansiety and depression,
      perceived health status and selfefficacy to practice of physical activity. At the end of the
      interviewThe same researcher opened the envelope to allocate the participants to either
      intervention or control group. The participants of intervention group remained with the
      researcher to receive the intervention.

      The educational programme consisted of four booklets entitled 1. Percutaneous Transluminal
      Coronary Angioplasty, 2. Going home after your coronary angioplasty, 3. How to take care of
      your heart and your health, and 4. How to practice physical activities. The educational
      programme included the telephone follow-up that contained three calls to motivate the
      participants to change their lifestyle and clarify doubts. The contents of the booklets were
      explained step by step to the participants by the researcher who conducted the interviews.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in physical activity level from baseline to five to seven months
time frame: baseline and five to seven months
description: The "Baecke Questionnaire of Habitual Physical Activity" was developed by Baecke, Burema and Frijters (1982) and validated for the Brazilian population by Florindo et al. (2004, 2006). The instrument has three dimensions: occupational physical activity (eight questions), physical activity during leisure time (four questions) and leisure and locomotion activities (four questions), totaling 16 questions. Higher scores indicate a higher level of physical activity. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
measure: Change in symptoms of anxiety and depression from baseline to five to seven months
time frame: baseline and five to seven months
description: The questionnaire "Hospital Anxiety and Depression Scale" was developed by Zigmond and Snaith (1983) and validated and adapted to Portuguese by Botega et al. (1995). The Hospital Anxiety and Depression Scale contains 14 multiple choice questions, divided into two subscales: anxiety and depression (composed of seven items each). Higher scores indicate more symptoms of anxiety and depression. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
measure: Change in perceived health status from baseline to five to seven months
time frame: baseline and five to seven months
description: The questionnaire "Medical Outcomes Survey 36 - Item Short-Form" developed by Ware and Sherboune (1992). The investigators used the version licensed by Quality Metric Incorporated (MARUISH, 2011) for use in surveys in Brazil. The Medical Outcomes Survey 36 - Item Short-Form is a multidimensional questionnaire composed of 36 items that evaluate eight health concepts: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental health and a comparative question that evaluate the current health conditions with one year ago. Higher values indicate better perceived health status. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
measure: Change in self-efficacy for physical activity from baseline to five to seven months
time frame: baseline and five to seven months
description: The questionnaire "Escala de Autoeficácia Para Prática de Atividade Física" developed by Rech et al. (2011) for Brazilian adults and by Borges et al. (2015) that used in the elderly population. This questionnaire was elaborated from two specific scales of self-efficacy for the practice of physical exercise, proposed by Sallis et al. (1988) and Bandura (2006). We used the Brazilian adult version (RECH et al., 2011) which contains two domains with five items each in which the answers are dichotomous ( "no" versus "yes"). Higher scores indicate better self-efficacy for physical activity. The instrument was used to collect the data at baseline and five to seven months after hospital discharge.
arm group label: Usual Care
arm group type: Active Comparator
description: At discharge, paticipants received guidance from health professionals. The paticipants had a medical return five to seven months after the percutaneous coronary intervention.
arm group label: Educational model + follow up
arm group type: Experimental
description: The paticipants received the hospital's instructions at discharge and participated in the educational program (booklets with telephone follow-up). The paticipants had a medical return five to seven months after discharge
intervention type: Behavioral
intervention name: educational model + follow up
description: Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)
arm group label: Educational model + follow up
intervention type: Behavioral
intervention name: usual care
description: Hospital health professionals offered orientation on care after discharge
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lidia A Rossi, PhD
role: Study Chair
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Natássia Condilo Pitta
investigator title: PhD Student
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Coronary Disease
mesh term: Arteriosclerosis
sharing ipd: No