<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/NCT03771937</url>
  </required_header>
  <id_info>
    <org_study_id>0001</org_study_id>
    <nct_id>NCT03771937</nct_id>
  </id_info>
  <brief_title>The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model</brief_title>
  <official_title>The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model After Myocardial Infarction: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akdeniz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akdeniz University</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 this parallel randomized controlled trial (n = 33/group), the control group received&#xD;
      routine care, while the intervention group received a telephone follow-up intervention, which&#xD;
      consisted of a pre-discharge education program and three telephone follow-up sessions based&#xD;
      on the Roy Adaptation Model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate the effect of education and telephone follow-up intervention based on&#xD;
      the Roy Adaptation Model (RAM) for improving MI patients' self-efficacy, quality of life and&#xD;
      lifestyle adaptation.&#xD;
&#xD;
      Methods: In this parallel randomized controlled trial (n = 33/group), the control group&#xD;
      received routine care, while the intervention group received a telephone follow-up&#xD;
      intervention, which consisted of a pre-discharge education program and three telephone&#xD;
      follow-up sessions based on the RAM. Data were collected before discharge, and in the 12th&#xD;
      week after discharge included quality of life, coping adaptation process, self-efficacy and&#xD;
      lifestyle changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2016</start_date>
  <completion_date type="Actual">September 25, 2017</completion_date>
  <primary_completion_date type="Actual">August 25, 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>Single (Participant)</masking>
    <masking_description>Single blinding was provided that included inclusion criteria and agreement to participate in the study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>General Self-Efficacy Scale</measure>
    <time_frame>12 week</time_frame>
    <description>The self-efficacy levels of the patients were measured by the General Self-Efficacy Scale (GSES). The GSES contains 10 items and each item score ranges from 0 to 5. Cronbach's α of the GSES was 0.83. The highest and lowest possible score is between 10-40. High score indicates that the individual perceives high self-efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coping and Adaptation scale</measure>
    <time_frame>12 week</time_frame>
    <description>To evaluate the coping and adaptation processes, the Coping and Adaptation (CAPS) scale was used. The CAPS was developed by Callista Roy. The Turkish validity and reliability study of the scale was conducted by Çatal and Dicle (2015), and the Cronbach alpha value was 0.82 for the total scale. The highest and lowest possible score is between 47-188. Higher scores indicate better use of effective coping methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Myocardial Infarction Dimensional Assessment Scale</measure>
    <time_frame>12 week</time_frame>
    <description>To evaluate the quality of life after the disease, the Myocardial Infarction Dimensional Assessment Scale (MIDAS) was used. This was developed by Thompson et al. in 2002. The Cronbach alpha values of the scale were found in seven dimensions, and ranged from 0.74 to 0.95, showing it to be a useful and highly reliable tool. The validity and reliability study of the scale was made by Yilmaz et al. Cronbach alpha values ranged from 0.79 to 0.90. The 10 highest and lowest possible score is between 0-100, with 0 indicating the best health condition, and 100 indicating the worst health condition.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the RAM.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the control group received routine care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education and telephone follow-up intervention</intervention_name>
    <description>A telephone follow up and a pre-discharge education</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants were adults aged ≥30 years and had been admitted to the hospital with a&#xD;
             diagnosis of MI (which must be supported by ECG and an increase in biomarkers).&#xD;
&#xD;
          2. were clinically stable&#xD;
&#xD;
          3. willing to participate&#xD;
&#xD;
          4. able to understand and write Turkish&#xD;
&#xD;
          5. able to receive telephone calls or fill in questionnaires.&#xD;
&#xD;
          6. able to come to the hospital for checkups. Exclusion Criteria:Patients were excluded&#xD;
             from the study if according to medical file records they had chronic renal failure,&#xD;
             cancer, heart failure, severe aortic stenosis, if they were planned for surgical&#xD;
             treatment or had chronic cognitive and psychiatric disease, if they had problems with&#xD;
             hearing and speaking on the phone, or if they had mobility restriction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Selma Turan Kavradım, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Akdeniz University Nursing Faculty</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zeynep Canlı ÖZER, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Akdeniz University Nursing Faculty</affiliation>
  </overall_official>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 5, 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>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Akdeniz University</investigator_affiliation>
    <investigator_full_name>Selma Turan</investigator_full_name>
    <investigator_title>Nursing Faculty</investigator_title>
  </responsible_party>
  <keyword>lifestyle change</keyword>
  <keyword>telephone follow-up</keyword>
  <keyword>Roy Adaptation Model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators plan to send the results to an international journal and all results can be obtained after publication.</ipd_description>
  </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/NCT03771937
org study id: 0001
nct id: NCT03771937
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this parallel randomized controlled trial (n = 33/group), the control group received
      routine care, while the intervention group received a telephone follow-up intervention, which
      consisted of a pre-discharge education program and three telephone follow-up sessions based
      on the Roy Adaptation Model.
Objective: To evaluate the effect of education and telephone follow-up intervention based on
      the Roy Adaptation Model (RAM) for improving MI patients' self-efficacy, quality of life and
      lifestyle adaptation.

      Methods: In this parallel randomized controlled trial (n = 33/group), the control group
      received routine care, while the intervention group received a telephone follow-up
      intervention, which consisted of a pre-discharge education program and three telephone
      follow-up sessions based on the RAM. Data were collected before discharge, and in the 12th
      week after discharge included quality of life, coping adaptation process, self-efficacy and
      lifestyle changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Single blinding was provided that included inclusion criteria and agreement to participate in the study
measure: General Self-Efficacy Scale
time frame: 12 week
description: The self-efficacy levels of the patients were measured by the General Self-Efficacy Scale (GSES). The GSES contains 10 items and each item score ranges from 0 to 5. Cronbach's α of the GSES was 0.83. The highest and lowest possible score is between 10-40. High score indicates that the individual perceives high self-efficacy.
measure: Coping and Adaptation scale
time frame: 12 week
description: To evaluate the coping and adaptation processes, the Coping and Adaptation (CAPS) scale was used. The CAPS was developed by Callista Roy. The Turkish validity and reliability study of the scale was conducted by Çatal and Dicle (2015), and the Cronbach alpha value was 0.82 for the total scale. The highest and lowest possible score is between 47-188. Higher scores indicate better use of effective coping methods.
measure: Myocardial Infarction Dimensional Assessment Scale
time frame: 12 week
description: To evaluate the quality of life after the disease, the Myocardial Infarction Dimensional Assessment Scale (MIDAS) was used. This was developed by Thompson et al. in 2002. The Cronbach alpha values of the scale were found in seven dimensions, and ranged from 0.74 to 0.95, showing it to be a useful and highly reliable tool. The validity and reliability study of the scale was made by Yilmaz et al. Cronbach alpha values ranged from 0.79 to 0.90. The 10 highest and lowest possible score is between 0-100, with 0 indicating the best health condition, and 100 indicating the worst health condition.
arm group label: Intervention
arm group type: Experimental
description: Intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the RAM.
arm group label: Control group
arm group type: No Intervention
description: the control group received routine care.
intervention type: Other
intervention name: Education and telephone follow-up intervention
description: A telephone follow up and a pre-discharge education
arm group label: Intervention
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Selma Turan Kavradım, PhD
role: Principal Investigator
affiliation: Akdeniz University Nursing Faculty
last name: Zeynep Canlı ÖZER, Professor
role: Study Director
affiliation: Akdeniz University Nursing Faculty
responsible party type: Principal Investigator
investigator affiliation: Akdeniz University
investigator full name: Selma Turan
investigator title: Nursing Faculty
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No
ipd description: The investigators plan to send the results to an international journal and all results can be obtained after publication.