<?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>IRCT20180609040020N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-12</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the impact of empowerment program on the quality of life of elderly people with Diabetes type 2</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact of empowerment program on the quality of life of elderly people with Diabetes type 2</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72037</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, the samples will be placed randomly in blocks (of 4) in two control and test groups (45 people in each group). For random assignment, it will be done in such a way that each group is considered to be 4 states and therefore 6 different states can be occur: AABB-ABAB-ABBA-BAAB-BABA-BBAA. The number of people in each group is equal and this work is repeated for 90 patients, Blinding description: The intervention group and the control group are marked with the letters A and B, and the person who gives the questionnaires to the participants and the statistician during the data analysis do not know which is the test group and which is the control group.</study_design>
      <phase>4</phase>
      <hc_freetext>Low quality of life of the elderly with diabetes.</hc_freetext>
      <i_freetext>Intervention group: Before the intervention, they will complete the diabetic quality of life questionnaire. In addition to the previous treatments, the patients in the intervention group will participate in empowerment sessions. The sessions will last for one month and two sessions per week (8 sessions in total) and each session will last for 45. The method of implementing the empowerment program in this research is based on Anderson's empowerment program, which is implemented through speaking and giving pamphlets..</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:
Information about the main outcome can be shared

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
To conduct meta-analysis research

Where to obtain:
Correspondence with email address: a.hesamzadeh@mazums.ac.ir

How to obtain:
Investigating the possibility of implementing the request by the responsible researcher and sending the document within less than a month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Hesamzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh Faculty of Nursing and Midwifery, Vesal St., Amir Mazandarani Blvd.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۶۷۱۵۷۹۳</zip>
        <telephone>+98 11 3336 7343</telephone>
        <email>a.hesamzadeh@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Hesamzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh Faculty of Nursing and Midwifery, Vesal St., Amir Mazandarani Blvd.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۶۷۱۵۷۹۳</zip>
        <telephone>+98 11 3321 9437</telephone>
        <email>a.hesamzadeh@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Willingness to participate in the study
Ability to speak and communicate
Being under the care and treatment of a doctor or a medical group
Obtaining a score of 7-10 according to the short mental test questionnaire (AMT)
Obtaining a score of 11-14 according to the Instrumental Activities of Daily Living (IADL) questionnaire
Obtaining a score of 15-45 according to the quality of life questionnaire of diabetes patients (DQoL)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having mental illness
Participating in courses and educational classes about diabetes in the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to lifestyle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before the intervention, they will complete the diabetic quality of life questionnaire. In addition to the previous treatments, the patients in the intervention group will participate in empowerment sessions. The sessions will last for one month and two sessions per week (8 sessions in total) and each session will last for 45. The method of implementing the empowerment program in this research is based on Anderson's empowerment program, which is implemented through speaking and giving pamphlets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score of patients with diabetes. Timepoint: Measuring the quality of life of patients with diabetes at the beginning of the study and 60 days after the intervention. Method of measurement: Quality of life questionnaire for patients with diabetes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-26</approval_date>
        <contact_name>Ethical committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology Building, Moalem Sq., Moalem Blvd. Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
