<?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>IRCT20150525022406N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-18</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of peer support on adherence to treatment in patients with diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of peer support on adherence to treatment, quality of life and health literacy in patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49199</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be randomly divided into intervention and control groups. In order to randomly assign participants in two groups, first 35 cards A (intervention group) and 35 cards B (control group) will be prepared. After shuffling the cards, participants are asked to take a card in order, then the samples will be placed in one of the intervention or control groups based on the removed card. In this way, all participants will have an equal chance to be in two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes type II.</hc_freetext>
      <i_freetext>Intervention 1: In this study, after identifying eligible individuals and obtaining informed consent for the first time, questionnaires of quality of life, adherence to treatment, health literacy, perceived social support were completed during the face-to-face interview and blood samples for HbA1c, height and Weight measurement will be done for each participant.Then, group training will be prepared for 3 days in order to match the basic information of the participants according to the latest current instructions of the Ministry of Health and after simplifying the concepts, it will be implemented. Questionnaires will be completed immediately after the end of the 3-day course and for the second time. Patients will then be randomly divided into intervention and control groups.The selection of peers will be done with the participation of health care providers present in the center, a checklist for assessing the ability of peers and face-to-face interviews with qualified individuals. The selected peers will then be trained. In addition to diabetes care knowledge, this training will include training specific skills needed by peers such as communication and problem solving skills. In the next stage, the participants of the intervention group will be randomly trained in one of the 4 groups. In order to randomize the cards A, B, C, D (10 cards each) will be prepared and the members of the intervention group will be asked to choose one after shuffling the cards. In this way, people will be randomly placed in one of the four peer training groups. By introducing peers to patients in each group, the peer support intervention program will begin for 3 months. In addition to the usual care program, this program will include a monthly group training session with a discussion approach and participation of all members (3 sessions in total), a monthly group exercise program session (3 sessions in total). In addition, according to the schedule, peers can call their patients during the agreed hours and talk to them about each patient's specific care issues. 3 months after the start of the intervention for the third time, the questionnaires will be completed for both intervention and control groups. Also, HbA1c and patients' BMI will be measured and recorded again. Intervention 2: Control group: usually diabetes clinic care includes weekly visit of a nutritionist and general practitioner and training using pamphlets in the diabetes center. Individuals in this group will also receive 3 days of diabetes care training, similar to the intervention group.</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:
Publication of the article The effect of peer support on the dependent variables of quality of life, adherence to treatment, perceived social support, glycosylated hemoglobin and body mass index

When:
Up to five years after sampling

To whom:
Supervisor and Research Consultants

Conditions:
Only for the publication of scientific articles

Where to obtain:
Deputy of Research, Shahid Beheshti School of Nursing and Midwifery,Tehran

How to obtain:
Written request to the research deputy of Shahid Beheshti School of Nursing and Midwifery, sent to the research deputy of the university and accept or reject the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahsavari, Arezoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Babaei Post  Office, Shahrdari four-way</address>
        <city>Aligudarz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6861617117</zip>
        <telephone>+98 66 4332 8642</telephone>
        <email>shahsavari_arezoo1397@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahsavari, Arezoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Babaei Post Office, Shahrdari four-way</address>
        <city>Aligudarz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6861617117</zip>
        <telephone>009843328642</telephone>
        <email>shahsavari_arezoo1397@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 6 months have passed since the doctor diagnosed them with type 2 diabetes
Be over 18 years old
Do not have a history of participating in educational programs in the field of diabetes during the past year
Have a desire to participate in the present study
Do not have cognitive problems
Do not have a physical disability
Do not need diabetic foot surgery
-Do not have medical or related education
It is possible to make a direct phone call with the patient</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Do not want to participate in the study
The patient has physical problems that they are not able to take care of themselves</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, after identifying eligible individuals and obtaining informed consent for the first time, questionnaires of quality of life, adherence to treatment, health literacy, perceived social support were completed during the face-to-face interview and blood samples for HbA1c, height and Weight measurement will be done for each participant.Then, group training will be prepared for 3 days in order to match the basic information of the participants according to the latest current instructions of the Ministry of Health and after simplifying the concepts, it will be implemented. Questionnaires will be completed immediately after the end of the 3-day course and for the second time. Patients will then be randomly divided into intervention and control groups.The selection of peers will be done with the participation of health care providers present in the center, a checklist for assessing the ability of peers and face-to-face interviews with qualified individuals. The selected peers will then be trained. In addition to diabetes care knowledge, this training will include training specific skills needed by peers such as communication and problem solving skills. In the next stage, the participants of the intervention group will be randomly trained in one of the 4 groups. In order to randomize the cards A, B, C, D (10 cards each) will be prepared and the members of the intervention group will be asked to choose one after shuffling the cards. In this way, people will be randomly placed in one of the four peer training groups. By introducing peers to patients in each group, the peer support intervention program will begin for 3 months. In addition to the usual care program, this program will include a monthly group training session with a discussion approach and participation of all members (3 sessions in total), a monthly group exercise program session (3 sessions in total). In addition, according to the schedule, peers can call their patients during the agreed hours and talk to them about each patient's specific care issues. 3 months after the start of the intervention for the third time, the questionnaires will be completed for both intervention and control groups. Also, HbA1c and patients' BMI will be measured and recorded again.</i_keyword>
      <i_keyword>Control group: usually diabetes clinic care includes weekly visit of a nutritionist and general practitioner and training using pamphlets in the diabetes center. Individuals in this group will also receive 3 days of diabetes care training, similar to the intervention group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>HbA1C. Timepoint: Before intervention , 3 months after the intervention. Method of measurement: Patient blood sample in the laboratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention ,  Immediately after the intervention, 3 months after the intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Health literacy. Timepoint: Before intervention , 3 months after the intervention. Method of measurement: Questionnaire Health literacy (TOFHLA).</sec_outcome>
      <sec_outcome>Diabetes self care dimension. Timepoint: Before intervention ,  Immediately after the intervention, 3 months after the intervention. Method of measurement: Diabetes Self-Care Questionnaire.</sec_outcome>
      <sec_outcome>Percieved Social Support(PRQ-85). Timepoint: Before intervention , 3 months after the intervention. Method of measurement: Percieved Social Support Questionnair.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before intervention ,  3 months after the intervention. Method of measurement: Weight and height measurement.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-01</approval_date>
        <contact_name>School of pharmacy and Nursing &amp; Midwifery-shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
