<?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>IRCT20210110049983N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-01</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-management program based on 5A model on self-care and quality of life in high blood pressure elderly patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-management program based on 5A model on self-care and quality of life in hypertensive elderly patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53617</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, as the first step are listed the medical records of all elderly patients with hypertension referred to the cardiac clinic of Mashhad Army Hospital. Then, elderly with inclusion criteria are selected and assigned in a simple random method to the two groups of control and intervention using a table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, a self-management program based on the 5A model will be implemented. This model includes 5 stages of evaluation, counseling, agreement, assistance and follow-up. four face-to-face and virtual sessions with a duration of 1-2 hours will be provided for the elderly and one of his family members, in order to implement training and planning in the field of self-management. The first session will be held in person for one to two hours to implement the first and second stages (evaluation and consultation), which will be held in groups of up to 7 people. Actions in this session include measuring blood pressure and BMI, Introducing the study, assessing the views and concerns of the elderly about hypertension, symptoms, complications and its impact on health and quality of life, as well as introducing the disease and its management methods. In a few days, the second session will be held virtually through WhatsApp for one hour to implement the third stage (agreement) individually for each elderly person and one of the family members. After agreeing on the goals, a specific self-management program will be provided to them and a checklist of individual actions will be sent to the patient, emphasizing the importance of taking notes and reporting actions and blood pressure to the patient and his companion. The third session will be a week later and for 2 hours, to perform the fourth stage (help) in the form of WhatsApp groups of 7 people, with the aim of simplifying the process of self-care and reminding the trainings and controlling the client checklist. The fifth stage (follow-up) is post-agreement follow-up, which is supported by the researcher twice a week, then once a week, bi-weekly, bi-weekly and monthly until the end of week 8 after the intervention by telephone to motivate, support And ambiguities. The final session will be held for 1 hour at the end of week 8 after the start of the intervention in groups of 7 people to complete the test post forms and checklists control. Intervention 2: Control group: In the control group, routine actions include face-to-face training sessions during the doctor's visit and providing an educational pamphlet on hypertension management.</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:
Demographic and contextual characteristics of study participants

When:
After September 1400

To whom:
all

Conditions:
Email the responsible author or access databases

Where to obtain:
Email the responsible author or access databases

How to obtain:
By email for about a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahmoud Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing AND Midwifery School, Doctra Crossroad, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>bakhshim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahmoud Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctra Crossroad, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>bakhshim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>60 years of age and older
A definitive diagnosis of hypertension by specialist
Informed consent to participate in the study
Ability to speak Persian
Be literate
get a score 7 or higher using the AMT tool
Ability to communicate through WhatsApp social network
Ability to perform daily activity livings and get a score of 13 or higher using the Bartel ADL tool</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cognitive impairment such as Alzheimer's, dementia, delirium (severe confusion)
Major depressive disorder or psychological disorders
Clear speech disorder
Clear and uncorrected vision or hearing problems
Acute physical problems such as uncontrolled diabetes, heart attack or stroke and lung infection</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>In the intervention group, a self-management program based on the 5A model will be implemented. This model includes 5 stages of evaluation, counseling, agreement, assistance and follow-up. four face-to-face and virtual sessions with a duration of 1-2 hours will be provided for the elderly and one of his family members, in order to implement training and planning in the field of self-management. The first session will be held in person for one to two hours to implement the first and second stages (evaluation and consultation), which will be held in groups of up to 7 people. Actions in this session include measuring blood pressure and BMI, Introducing the study, assessing the views and concerns of the elderly about hypertension, symptoms, complications and its impact on health and quality of life, as well as introducing the disease and its management methods. In a few days, the second session will be held virtually through WhatsApp for one hour to implement the third stage (agreement) individually for each elderly person and one of the family members. After agreeing on the goals, a specific self-management program will be provided to them and a checklist of individual actions will be sent to the patient, emphasizing the importance of taking notes and reporting actions and blood pressure to the patient and his companion. The third session will be a week later and for 2 hours, to perform the fourth stage (help) in the form of WhatsApp groups of 7 people, with the aim of simplifying the process of self-care and reminding the trainings and controlling the client checklist. The fifth stage (follow-up) is post-agreement follow-up, which is supported by the researcher twice a week, then once a week, bi-weekly, bi-weekly and monthly until the end of week 8 after the intervention by telephone to motivate, support And ambiguities. The final session will be held for 1 hour at the end of week 8 after the start of the intervention in groups of 7 people to complete the test post forms and checklists control.</i_keyword>
      <i_keyword>Control group: In the control group, routine actions include face-to-face training sessions during the doctor's visit and providing an educational pamphlet on hypertension management.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care. Timepoint: Beginning and end of the study at the end of week 8. Method of measurement: Han Self-Care Questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Beginning and end of the study at the end of week 8. Method of measurement: SF-36 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-10</approval_date>
        <contact_name>Iran National Committee for ethics in Biomedical Research</contact_name>
        <contact_address>Ethics Committee of Mashhad University of Medical Sciences, Qureshi Building, Daneshgah St., Mashhad, Iran mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
