<?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>IRCT20190528043744N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-12</date_registration>
      <primary_sponsor>Islamic Azad University, Karaj Branch</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Motivational Interviewing in Accordance with the AIM Model and Family Empowerment Model Based on Self-Compassion in treatment of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Motivational Interviewing in Accordance with the AIM model and Family Empowerment model Based on Self-Compassion on Adherence to Treatment, Self-Care, Health-Related Quality of life Dependent Diabetes and Glycosylated Hemoglobin in Patients with Diabetes II</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39881</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, individuals are randomly divided into two groups of intervention and one control group using random number table. In this method, the first selected number (randomly) set in the first intervention group and the next numbers assign to the second intervention and control groups respectively. Intervention group 1 receive drug treatments 8 sessions of motivational interviewing in accordance with AIM model, intervention group 2 receive drug treatments and 8 sessions of motivational interviewing in accordance with family empowerment model based on self-compassion and the third group as the control, only receive drug treatments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with type II diabetes.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group 1: Drug treatments and 8 sessions of motivational interviewing in accordance with AIM model receive 2 to 2.5 hours and twice a week. Intervention 2: Intervention group 2: Drug treatments and 8 sessions of motivational interviewing in accordance with family empowerment model based on self-compassion receive 2 to 2.5 hours and twice a week. Intervention 3: Control group: They only receive drug treatment.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All related data to participants are shared after hiding patient's name.

When:
The period of access to the present research data will be available 6 months after publication of the research results in the form of research articles.

To whom:
The present study data will be available only to researchers working in the academic and scientific institutions.

Conditions:
The output of statistical analysis will be available

Where to obtain:
Applicants can apply for documentation and data via email at soheilarahmani_sh@yahoo.com

How to obtain:
After completion of the research and publication of the extracted articles, it will be available for a maximum 6 months later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Rahmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, 1st West Sarvestan Ave., Rahahan Town, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1358879331</zip>
        <telephone>+98 21 5532 8101</telephone>
        <email>soheilarahmani_sh@gmail.com</email>
        <affiliation>Islamic Azad University, Karaj Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Rahmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, 1st West Sarvestan Ave., Rahahan Town, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1358879331</zip>
        <telephone>+98 21 5532 8101</telephone>
        <email>soheilarahmani_sh@gmail.com</email>
        <affiliation>Islamic Azad University, Karaj Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 30-55 years
Having diabetes type 2 for at least six months with a specialist physician diagnosis
Higher education than the cycle
Not using other treatment psychotherapy programs and changing medications during the research</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have other types of diabetes
Have severe diabetic complications that prevent research
Acute or chronic medical illness that may cause problems with blood sampling</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group 1: Drug treatments and 8 sessions of motivational interviewing in accordance with AIM model receive 2 to 2.5 hours and twice a week.</i_keyword>
      <i_keyword>Intervention group 2: Drug treatments and 8 sessions of motivational interviewing in accordance with family empowerment model based on self-compassion receive 2 to 2.5 hours and twice a week.</i_keyword>
      <i_keyword>Control group: They only receive drug treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effectiveness of motivational interviewing of the  AIM model in adherence to treatment. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Morisky's adherence treatment questionnaire.</prim_outcome>
      <prim_outcome>The effectiveness of motivational interviewing of the  AIM model in self-care. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Short-term scale of Tobert's diabetics self-care activities.</prim_outcome>
      <prim_outcome>The effectiveness of motivational interviewing of the  AIM model in quality of life. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Wang's Quality of Life Questionnaire of Diabetes.</prim_outcome>
      <prim_outcome>The effectiveness of motivational interviewing of the AIM model in glycosylated hemoglobin. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>The effectiveness of Family Empowerment Model Based on Self-Compassion on adherence to treatment. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Morisky's adherence treatment questionnaire.</prim_outcome>
      <prim_outcome>The effectiveness of Family Empowerment Model Based on Self-Compassion on self-care. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Short-term scale of Tobert's diabetics self-care activities.</prim_outcome>
      <prim_outcome>The effectiveness of Family Empowerment Model Based on Self-Compassion on quality of life. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Wang's Quality of Life Questionnaire of Diabetes.</prim_outcome>
      <prim_outcome>The effectiveness of Family Empowerment Model Based on Self-Compassion on glycosylated hemoglobin. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adherence of treatment. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Morisky's adherence treatment questionnaire.</sec_outcome>
      <sec_outcome>The amount of self-care. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Short-term scale of Tobert's diabetics self-care activities.</sec_outcome>
      <sec_outcome>Level of quality of life. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Wang's quality of life questionnaire of diabetes.</sec_outcome>
      <sec_outcome>Amount of glycosylated hemoglobin. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Score of self-compassion. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: The scale of self-compassion.</sec_outcome>
      <sec_outcome>Score of the coping styles. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Lazarus coping strategies questionnaire.</sec_outcome>
      <sec_outcome>Score of perceived social support. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: Multidimensional scale of Ziment perceived social support.</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>Islamic Azad University, Karaj Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-02</approval_date>
        <contact_name>Ethics committee of Islamic Azad University, Karaj Branch</contact_name>
        <contact_address>Islamic Azad University, Karaj Branch, Moazzen Blvd., Rajai Shahr, Karaj, Alborz Province Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
