<?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>IRCT20210302050552N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-27</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of spiritual self-care educational program in the form of CD along with telephone follow-up on the quality of life of stroke patients and their caregivers after discharge from hospitals.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual self-care educational program in the form of compact disc (CD) along with telephone follow-up on the quality of life of stroke patients and their caregivers after discharge from hospitals.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54876</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Samples will be divided into intervention and control groups using simple random assignment. In order to place the patient in the control or intervention group, we ask the patient or his companion to take a card out of the bag at random and depending on whether the selected card number is randomly paired or odd, the patient assigned in the intervention or control group.  This drawing consists of a bag containing 70 cards with numbers from 1 to 70 written on them) Each card that is selected is discarded from the bag. By contract, the card selectors with even number will be in the intervention group and the card selectors with odd numbers will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of Life.</hc_freetext>
      <i_freetext>Intervention 1: The content of the spiritual self-care program through a CD contains various items such as audio, video  and PowerPoint files of experts in this field  for spiritual promotion that are provided to patients with stroke and their caregivers. During the intervention, patients and their caregivers  are followed by phone and Whats App about their questions, and feedback, and how to do the exercises. Intervention 2: In order to compare the results of the intervention in the intervention group, this group will not receive content.</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:
All participants' personal data can be shared after identifying individuals

When:
Access period starts from 1401

To whom:
Only researchers working in academic and scientific institutions will be allowed to access the data of this study

Conditions:
The use of the results of this study and personal data is allowed after identifying individuals

Where to obtain:
Hojatollah Yousefi, School of Nursing and Midwifery, Isfahan University of 
Medical Sciences, Hezar Jarib St, 81746 -73461   Email: yousefi@nm.mui.ac.ir, Mobile: 09133022900, Tel:+98 31 37927543, Fax:+98 31 36699398

How to obtain:
After confirming the study and printing the results, the information will be available through the irct site using the search terms related to the study

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hojatollah Yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib St</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۱</zip>
        <telephone>+98 31 3792 7500</telephone>
        <email>yousefi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hojatollah Yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib St</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۱</zip>
        <telephone>+98 31 3792 7500</telephone>
        <email>yousefi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients with definitive diagnosis of stroke for the first time
The patient's Bartel index score is equal or less than 90
The patient has a hospital record in Isfahan Ayatollah Kashani Hospital
The patient is being discharged from the hospital
Before the stroke, the patient was independent in performing his/her tasks,
The patient and caregiver are willing to participate in the study and have given informed written consent.
Physical and mental readiness of the patient to answer questions
Patient or caregiver is literate
The patient and caregiver should  be able to speak Persian
The caregivers were older than 18
The caregiver delivers care to the patient in 24 hours.
The caregiver should not receive any remuneration for the care
Caregiver and patient have a computer or cell phone with android system</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient has  global  or Wernicke aphasia
The patient does not have congestive heart failure ( CHF) , mental retardation and renal failure with dialysis
The patient or caregiver  have a serious physical or mental disorder
The patient with an acute condition
Receiving specific stroke rehabilitation as a complementary treatment program by the patient
patient with low consciousness
caregivers have a history of participating in a training program or research related to this study
Patient or caregiver with visual or auditory impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I67.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebrovascular disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The content of the spiritual self-care program through a CD contains various items such as audio, video  and PowerPoint files of experts in this field  for spiritual promotion that are provided to patients with stroke and their caregivers. During the intervention, patients and their caregivers  are followed by phone and Whats App about their questions, and feedback, and how to do the exercises.</i_keyword>
      <i_keyword>In order to compare the results of the intervention in the intervention group, this group will not receive content.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean score of quality of life of stroke patients  in William's stroke quality of life questionnaire for patients. Timepoint: Measuring the quality of life of patients  at the beginning of the study (before the intervention) and immediately and 6 weeks after the start of their use of the content of the spiritual self-care program. Method of measurement: William Stroke Quality of Life Questionnaire for Patients.</prim_outcome>
      <prim_outcome>Mean quality of life score of caregivers of stroke patients with general quality of life questionnaire for caregivers. Timepoint: Measuring the quality of life of  caregivers at the beginning of the study (before the intervention) and immediately and 6 weeks after the start of their use of the content of the spiritual self-care program. Method of measurement: General Quality of Life Questionnaire for Caregivers.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-08</approval_date>
        <contact_name>Ethics Committee of the School of Nursing, Management and Rehabilitation, Isfahan University of Medi</contact_name>
        <contact_address>Hezar Jarib St., Isfahan University of Medical Sciences, School of Nursing and Midwifery, Ethics Committee Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
