<?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>IRCT20150519022320N30</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-21</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of self-care based on the Orem’s model with the Pender's health promotion model on medication adherence and quality of life of the elderly with hypertension.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of self-care based on the Orem’s model with the Pender's health promotion model on medication adherence and quality of life of the elderly with hypertension.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71400</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After identifying the elderly who meet the study entry criteria and listing them, they will be divided into 3 groups of 31 people A, B and C by simple random division using a table of random numbers, and then again the groups will be divided by simple random division type Intervention on each group (two intervention groups and one control group) It will be determined what intervention will be done on each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hypertnsion.</hc_freetext>
      <i_freetext>Intervention 1: In the self-care intervention group of the Orem model, after stating the goals and obtaining the patients' satisfaction, the self-care needs of the patients will be determined based on the Orem assessment and recognition forms designed by the researcher with an emphasis on medication adherence and quality of life. These needs will be identified in three dimensions: general self-care needs, developmental self-care needs, and health deviation self-care needs. After determining the needs of the patients, self-care program for one month (first session in the first week, second and third session in the second week, fourth and fifth session in the third week and sixth session in the fourth week) and in 6 sessions in the way of face to face and in groups. It will be implemented. The participants will be divided into 3 groups of 8 and one group of 7 people and will be trained in 6 sessions of 45 to 60 minutes. The meetings will be held in the form of discussions, questions and answers, presentation of booklets and pamphlets by the researcher, at the Rafsanjan College of Nursing and Midwifery, the content of the meetings will be prepared based on reliable sources. And during this period, communication will be established with patients through mobile phones. And at the end of each session, an educational pamphlet will be given to the patients according to the recommendations and training given, and during the week the patient will be monitored by phone calls in terms of carrying out the given training. At the end of the study, the standard questionnaire of the quality of life of the elderly and the Moriski medication adherence questionnaire will be completed by the patients. Intervention 2: Intervention group: In the intervention group of the Pender health promotion model, a survey and assessment form for the individual needs of the participants will be designed with an emphasis on medication adherence items and quality of life components. These needs are identified according to the constructs of the model, including evaluation in terms of perceived benefits, perceived barriers, family and social relationships, perceived self-efficacy, knowing the benefits of having a commitment to performing the behavior. After determining the needs of the patients, the content of the intervention was prepared based on reliable sources and the necessary information regarding behavior change for one month (the first session in the first week, the second and third sessions in the second week, the fourth and fifth sessions in the third week and the sixth session in the fourth week) and will be provided to the participants in 6 sessions in the way of face to face and in groups. The participants will be divided into 3 groups of 8 and one group of 7 and will be trained in 6 sessions of 45 to 60 minutes. The sessions will be held in the form of discussions, questions and answers, presentation of booklets and pamphlets by the researcher, at the Rafsanjan College of Nursing and Midwifery. And during this period, communication will be established with patients through mobile phones. And at the end of each session, an educational pamphlet will be given to the patients according to the recommendations and training given, and during the week the patient will be monitored by phone calls in terms of carrying out the given training. At the end of the study, the standard questionnaire of the quality of life of the elderly and the Moriski medication adherence questionnaire will be completed by the patients. Intervention 3: Control group: During the study period, there will be no intervention in the control group and the questionnaires will be completed by the participants.</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 No further information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ali Ravari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali Ravari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being over 60 years old
History of high blood pressure for at least 6 months
Elderly people who have poor and moderate medication compliance (getting a score of less than 6 and a score of 6 to less than 8) based on Moriski's eight-question medication adherence questionnaire
Basic reading and writing skills
Not having a hearing or speech defect
Absence of serious physical disability and associated chronic debilitating diseases (such as chronic lung cancer, heart failure disease, rheumatoid arthritis, and lupus erythematosus), which would interfere with self-care
Having a mobile phone in order to coordinate meetings and communicate with clients
Ability to participate in training sessions
Not suffering from known mental illnesses
Willingness to participate in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-cooperation based on the training programs
Hospitalization during the course
Consecutive absence in two sessions or absence in one third of all 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>Lifestyle</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the self-care intervention group of the Orem model, after stating the goals and obtaining the patients' satisfaction, the self-care needs of the patients will be determined based on the Orem assessment and recognition forms designed by the researcher with an emphasis on medication adherence and quality of life. These needs will be identified in three dimensions: general self-care needs, developmental self-care needs, and health deviation self-care needs. After determining the needs of the patients, self-care program for one month (first session in the first week, second and third session in the second week, fourth and fifth session in the third week and sixth session in the fourth week) and in 6 sessions in the way of face to face and in groups. It will be implemented. The participants will be divided into 3 groups of 8 and one group of 7 people and will be trained in 6 sessions of 45 to 60 minutes. The meetings will be held in the form of discussions, questions and answers, presentation of booklets and pamphlets by the researcher, at the Rafsanjan College of Nursing and Midwifery, the content of the meetings will be prepared based on reliable sources. And during this period, communication will be established with patients through mobile phones. And at the end of each session, an educational pamphlet will be given to the patients according to the recommendations and training given, and during the week the patient will be monitored by phone calls in terms of carrying out the given training. At the end of the study, the standard questionnaire of the quality of life of the elderly and the Moriski medication adherence questionnaire will be completed by the patients.</i_keyword>
      <i_keyword>Intervention group: In the intervention group of the Pender health promotion model, a survey and assessment form for the individual needs of the participants will be designed with an emphasis on medication adherence items and quality of life components. These needs are identified according to the constructs of the model, including evaluation in terms of perceived benefits, perceived barriers, family and social relationships, perceived self-efficacy, knowing the benefits of having a commitment to performing the behavior. After determining the needs of the patients, the content of the intervention was prepared based on reliable sources and the necessary information regarding behavior change for one month (the first session in the first week, the second and third sessions in the second week, the fourth and fifth sessions in the third week and the sixth session in the fourth week) and will be provided to the participants in 6 sessions in the way of face to face and in groups. The participants will be divided into 3 groups of 8 and one group of 7 and will be trained in 6 sessions of 45 to 60 minutes. The sessions will be held in the form of discussions, questions and answers, presentation of booklets and pamphlets by the researcher, at the Rafsanjan College of Nursing and Midwifery. And during this period, communication will be established with patients through mobile phones. And at the end of each session, an educational pamphlet will be given to the patients according to the recommendations and training given, and during the week the patient will be monitored by phone calls in terms of carrying out the given training. At the end of the study, the standard questionnaire of the quality of life of the elderly and the Moriski medication adherence questionnaire will be completed by the patients.</i_keyword>
      <i_keyword>Control group: During the study period, there will be no intervention in the control group and the questionnaires will be completed by the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Medication adherence in elderly with hypertension. Timepoint: All participants will complete Moriski's medication adherence questionnaire at the beginning and then at the end of the interventions. Method of measurement: Moriski's Medication Adherence Questionnaire.</prim_outcome>
      <prim_outcome>Quality of life of the elderly with hypertension. Timepoint: All participants will complete the Bowling's quality of life of the elderly questionnaire at the beginning and then at the end of the interventions. Method of measurement: Bowling's Quality of Life of The Elderly Questionnaire.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-19</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Nurse avenue, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
