<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200317046802N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of The Effectiveness of Family Care Based on Health Belief Model and Education of Health Promotion Lifestyle Acceptance and Commitment Therapy in Asthma Patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of The Effectiveness of Family Care Based on Health Belief Model and Education of Health Promotion Lifestyle on illness Perception and Physical Symptoms in Asthma Patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46696</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Based on the inclusion criteria and the performance of a pre-test session of 40 individuals who scored lower than the average after completing the Health Belief Forms Questionnaire and Health Promoting Styles Questionnaire and Illness Perception Questionnaire, they were selected by purposeful sampling. Since the study groups are equal in sample size, we use simple random allocation law, which is one of the limited randomization methods, and we divide the individuals into two intervention and control groups. We record patient data on 40 separate sheets and place the sheets inside the draw container and then randomly record 20 sheets out of the intervention group and place the remaining 20 sheets in the control group. To give. If there was a loss in treatment sessions, the sample size would be randomly eliminated in order to equalize the sample size, and eventually the number of subjects in both groups should be the same. Intervention group (n = 20) will have 8 sessions of 120 minutes acceptance and commitment therapy intervention and control group will not receive any intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asthma disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: There are 20 asthma sufferers who complete the Health Promoter Questionnaire (Walker et al., 1987) short-form questionnaires (Walker et al., 1987) before completing the protocol, with complete specifications. . In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks. Intervention 2: Control Group: There are 20 Patients With asthma WHO Complete the Health Promoter (Walker et al. 1987) Shortlisted Test With a Complete List of Specifications in the Pre-Test Questionnaire. This Group has Routine Care For 4 Weeks and no Extra Work is Done on Them. After 4 Weeks, this Group Also Completes the Questionnaires After the Test.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is En Upon completion of the dissertation the expected outcome will be decided upon.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Asani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3 , Kohdayar Alley, Shadman Ave., Sattarkhan St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>145663464</zip>
        <telephone>+98 21 2394 3107</telephone>
        <email>lasani@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrdad Sabet</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Rudehen</address>
        <city>Rudehen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3973188981</zip>
        <telephone>+98 21 7650 5891</telephone>
        <email>info@riau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tendency to Participate in Research Projects, Age Range 30 to 60 Years
Have a Minimum of Literacy
Be treated for at Least One Year (With the Approval of the Relevant Specialist)
Consent to Participate in Research
Low Score of Lifestyle Questionnaire and Health Perception Related to Health Promotion</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Kidney and Liver Disease
Use of Psychotropic Drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asthma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: There are 20 asthma sufferers who complete the Health Promoter Questionnaire (Walker et al., 1987) short-form questionnaires (Walker et al., 1987) before completing the protocol, with complete specifications. . In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks.</i_keyword>
      <i_keyword>Control Group: There are 20 Patients With asthma WHO Complete the Health Promoter (Walker et al. 1987) Shortlisted Test With a Complete List of Specifications in the Pre-Test Questionnaire. This Group has Routine Care For 4 Weeks and no Extra Work is Done on Them. After 4 Weeks, this Group Also Completes the Questionnaires After the Test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Short-Term Form of Disease Perception (Bradbent et al. 2006), Related to Health in Physical and Mental Symptoms. Timepoint: At the Beginning of the Study (Before the Intervention) and After 8 Sessions of Group Therapy, Acceptance and Commitment. Method of measurement: Short Scale of Disease Perception (Bradbent et al. 2006), Lifestyle Questionnaire with Health-Related Physical and Mental Symptoms.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lifestyle Score (Walker et al. 1987) Related to Health in Physical and Mental Symptoms. Timepoint: Scores of Health Promoting Lifestyle Questionnaires (Walker et al. 1987); Illness Perception (Bradbott et al. 2006); at Baseline (Before Intervention) and After Treatment Protocol Implementation. Method of measurement: Short Form Perceptions Questionnaire (Bradbott et al. 2006); Health Promoting Lifestyle Questionnaires (Walker et al. 1987).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>En Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Blvd., Hormozgan University of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
