<?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>IRCT20110427006318N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-17</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The role of liaison nurse on satisfaction, therapeutic adherence and sleep quality on hypertensive patients</public_title>
      <acronym></acronym>
      <scientific_title>The role of liaison nurse on satisfaction, therapeutic adherence and sleep quality on hypertensive patients referring to a hypertension clinic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88704</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible patients referred to the blood pressure clinic of Semnan Kosar Hospital will be included in the study using a convenience sampling method. At the beginning of the work, we will randomly determine which letter A or B represents the intervention or control group by using a coin toss. In the next step, using the Sealedenvelope website (https://www.sealedenvelope.com/simple-randomiser/v1/lists) and using the Restricted Randomization method with blocks of six, the patients will be randomly divided into two groups A and B. In other words, for every six patients who enter the study consecutively, 3 people will be randomly placed in group A and 3 people in group B. We write the letters A and B of the random sequence generated by the software on pieces of paper and place them inside sealed envelopes. We open the envelopes in order of patients entering the clinic and assign the individual to the relevant group based on their content.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, at the beginning of the study, patients who meet the conditions for inclusion in the study are given sufficient explanations about the method and objectives of the study. After obtaining oral and written informed consent, they complete the demographic information questionnaires, Wolf patient satisfaction, treatment adherence in patients with chronic diseases Modanloo, and the Pittsburgh Sleep Quality Index. Then, during a 15-minute session, they are taught the concept of hypertension, lifestyle modification, the correct way to take medications, and how to correctly measure blood pressure. Then, an educational pamphlet for home care is provided to the patient. From the time of referral until one month later, the liaison nurse will be in contact with the patients in the intervention group by telephone and provide the necessary guidance and answer their questions. One month after referral, they complete the satisfaction, treatment adherence, and sleep quality questionnaires again. Intervention 2: Control group: In this group, at the beginning of the study, patients who meet the conditions for inclusion in the study are given sufficient explanations about the method and objectives of the study. After obtaining oral and written informed consent, they complete the demographic information questionnaires, Wolf patient satisfaction, treatment adherence in patients with chronic diseases Modanloo, and the Pittsburgh Sleep Quality Index. This group is not given any training. One month after their referral, they complete the satisfaction, treatment adherence, and sleep quality questionnaires again. In order to comply with ethics in research in the control group, after the end of the study, they are taught the concept of hypertension, lifestyle modification, the correct way to take medications, and how to correctly measure blood pressure. Then, an educational pamphlet for home care is provided to the patient.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Data is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Monir Nobahar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty Nursing and Midwifery, Semnan University of Medical Sciences, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4190</telephone>
        <email>nobahar43@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Monir Nobahar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty Nursing and Midwifery, Semnan University of Medical Sciences, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4190</telephone>
        <email>nobahar43@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 40 - 60 years old
Ability to read and write
Ability to understand and respond to questionnaire items
Presence of sleep problems, defined as a Pittsburgh Sleep Quality Index (PSQI) score greater than 5
Treatment adherence of less than 50%
Willingness to participate in the study and to sign the informed consent form
Not being a member of healthcare staff
No routine use of antidepressant, anti-anxiety, sedative, or analgesic medications
Definitive diagnosis of hypertension, defined as a chronic blood pressure of ≥140/90 mmHg
Having access to a mobile phone or a landline telephone</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal from continued collaboration with the liaison nurse
Failure to respond to telephone calls
Hospitalization of the patient
Death of the patient</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, at the beginning of the study, patients who meet the conditions for inclusion in the study are given sufficient explanations about the method and objectives of the study. After obtaining oral and written informed consent, they complete the demographic information questionnaires, Wolf patient satisfaction, treatment adherence in patients with chronic diseases Modanloo, and the Pittsburgh Sleep Quality Index. Then, during a 15-minute session, they are taught the concept of hypertension, lifestyle modification, the correct way to take medications, and how to correctly measure blood pressure. Then, an educational pamphlet for home care is provided to the patient. From the time of referral until one month later, the liaison nurse will be in contact with the patients in the intervention group by telephone and provide the necessary guidance and answer their questions. One month after referral, they complete the satisfaction, treatment adherence, and sleep quality questionnaires again.</i_keyword>
      <i_keyword>Control group: In this group, at the beginning of the study, patients who meet the conditions for inclusion in the study are given sufficient explanations about the method and objectives of the study. After obtaining oral and written informed consent, they complete the demographic information questionnaires, Wolf patient satisfaction, treatment adherence in patients with chronic diseases Modanloo, and the Pittsburgh Sleep Quality Index. This group is not given any training. One month after their referral, they complete the satisfaction, treatment adherence, and sleep quality questionnaires again. In order to comply with ethics in research in the control group, after the end of the study, they are taught the concept of hypertension, lifestyle modification, the correct way to take medications, and how to correctly measure blood pressure. Then, an educational pamphlet for home care is provided to the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Satisfaction. Timepoint: Before and one month after discharge. Method of measurement: Wolf Patients Satisfaction Instrument.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adherence. Timepoint: Before and one month after discharge. Method of measurement: Treatment adherence in patients with chronic disease Modanloo.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: Before and one month after discharge. Method of measurement: Pittsburg Sleep Quality Index (PSQI).</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-14</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Science</contact_name>
        <contact_address>Faculty Nursing and Midwifery, Semnan University of Medical Sciences, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
