<?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>IRCT20260613069762N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-07</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of the Ask Me 3 Program on Treatment Adherence and Blood Pressure Control in Adults with Hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of the “Ask Me 3” Educational Program on Treatment Adherence and Blood Pressure Management in Adults with Hypertension: A Randomized Parallel Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/90837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The educational intervention in this study is based on the Ask Me 3 program and consists of three in-person training sessions, along with telephone follow-ups and the provision of an educational booklet. Furthermore, the socio-economic strata of Shahroud city will be taken into account when selecting the participants, Randomization description: After obtaining informed consent, a 1:1 random allocation sequence will be generated using Random Allocation Software. The allocation sequence will be prepared by an independent person and kept in sequentially numbered, sealed opaque envelopes. Participants will be assigned to the intervention or control group according to the allocation sequence after enrollment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will receive the Ask Me 3 educational program in three 45-minute face-to-face sessions over three consecutive days. Each session will focus on one of the three Ask Me 3 questions: “What is my main problem?”, “What do I need to do?”, and “Why is it important for me to do this?”. The content will cover hypertension, medication adherence, healthy diet and salt reduction, physical activity, blood pressure monitoring, and self-care. The sessions will be delivered by the researcher using an educational booklet and poster, followed by weekly telephone follow-up for 12 weeks to reinforce the educational content. Intervention 2: Control group: Receiving routine education provided by health centers.</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 -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ruhollah hadinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.13 , Rezvan alley, Yas 60, Kargar street</address>
        <city>Qaemshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4764635938</zip>
        <telephone>+98 11 4204 8503</telephone>
        <email>rhadinezhad555@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ruhollah hadinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 13 , Rezvan alley, Yas 60, Kargar Street</address>
        <city>Qaemshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4764635938</zip>
        <telephone>+98 11 4204 8503</telephone>
        <email>Rhadinezhad555@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age at least 40 years and older
Diagnosis of primary hypertension (systolic 130–139 mmHg and diastolic 80–89 mmHg)
Use of at least one antihypertensive medication within the last three months
Possession of hearing, speaking, and communication abilities
At least three months have passed since diagnosis
A minimum score of 10 on the Lawton Instrumental Activities of Daily Living (IADL) scale
A minimum score of 7 on the Abbreviated Mental Test (AMT)
Normal result on the Mini-Cog test</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of acute cardiac, renal, hepatic, or respiratory diseases, malignancies, stroke, or substance addiction
Diagnosis of depression and anxiety documented in the medical record
Participation in similar educational sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will receive the Ask Me 3 educational program in three 45-minute face-to-face sessions over three consecutive days. Each session will focus on one of the three Ask Me 3 questions: “What is my main problem?”, “What do I need to do?”, and “Why is it important for me to do this?”. The content will cover hypertension, medication adherence, healthy diet and salt reduction, physical activity, blood pressure monitoring, and self-care. The sessions will be delivered by the researcher using an educational booklet and poster, followed by weekly telephone follow-up for 12 weeks to reinforce the educational content.</i_keyword>
      <i_keyword>Control group: Receiving routine education provided by health centers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1-Treatment adherence. Timepoint: "At the beginning of the intervention (before the start of the intervention), one week after the end of the intervention, and three months after the end of the intervention.". Method of measurement: 1. Modanlou Medication Adherence Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>1-Systolic and Diastolic blood pressure. Timepoint: "At the beginning of the intervention (before the start of the intervention), one week after the end of the intervention, and three months after the end of the intervention.". Method of measurement: Electronic blood pressure monitor.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-09</approval_date>
        <contact_name>The Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>7 Tir Square, Next to Shahroud Municipality, Shahroud, Semnan Province, Iran SHAHROUD Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
