<?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>IRCT20220417054561N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-07</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of smartphone software based Self Management Education on the quality of life of Parkinson's disease</public_title>
      <acronym>PDQ (parkinson disease quality of life)</acronym>
      <scientific_title>Evaluation of the effect of smartphone software based Self Management Education on the quality of life in Parkinson's disease patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>77</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63080</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: It is a quasi-experimental one-group study (intervention group with 77 samples) that is designed to evaluate the effect of self-management education through software.</study_design>
      <phase>2</phase>
      <hc_freetext>Parkinson`s disease.</hc_freetext>
      <i_freetext>Intervention group: The self-management content provided by the smartphone software was provided from up-to-date, evidence-based medical, nursing, and rehabilitation sources. The accuracy, precision, and validity of this information was confirmed by three faculty members of the School of Nursing and Midwifery of Iran University of Medical Sciences. To conduct this quasi-experimental study, there was a need for an application that could be installed on a smartphone running the Android operating system, which could be used online and offline. The main features of this software are: educational content related to 1- Familiarity with the nature of the disease and motor and non-motor symptoms (general view of the disease) 2- Treatment methods, follow-up recommendations and adherence to medical and pharmaceutical treatment, Monitoring symptoms, 3- Self-management measures in physical symptoms (imbalance, gait disturbance and freezing, brady Keynesian, stiffness and tremor, muscle cramps, dyskinesia, tremor, masked face), 4- Self-management measures in symptoms Non-physical (cardiovascular problems, sleep and fatigue, mood and cognition, memory and concentration, gastrointestinal symptoms, nutrition management, urinary symptoms, self-efficacy, social support), 5- Talk to families (to prepare and improve home conditions , And supporting the family in using the software and accompanying the patient's family in self-management) 6- Frequently asked questions, 7- Contacting the caring nurse (researcher); This software, called "Parkin Seven", was divided into 7 parts and presented 7 recommendations in each part, was provided to the research units. All information in the software is based on scientific evidence and extracted from sites and scientific journals and authoritative books related to the subject and was provided to the clients at once by the smartphone software. Due to dyskinesia and other complications (such as tremors and visual disturbances) related to the disease and restrictions on the use of smartphones, images and text could  magnify. This software is designed to inform patients and their families by providing information about the disease, symptoms, symptom management, treatment, and self-care training in the form of text and photos..</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:
The statistical data are based on the Parkinson's Quality of Life Questionnaire, which has eight dimensions. By sharing statistical methods, the score of each dimension of the questionnaire and the overall quality of life score are also shared. Other characteristics, such as demographic information, will be unrecognizable.

When:
The access period will start after the results are published.

To whom:
Any findings from these results will be available to everyone.

Conditions:
Academic researchers will be allowed to access and perform any analysis and use to improve the quality of care, rehabilitation, and quality of life for patients.

Where to obtain:
Interested researchers can receive them by sending an e-mail to kzeighami76@gmail.com, stating the purposes of accessing the documents. With the permission of the responsible author, Dr. Khachian, the file will be sent to them. In addition, in the publication of their research, that have been done with the help and use of the documents of this research, accurate reference should be made.

How to obtain:
Interested researchers can receive them by sending an e-mail to kzeighami76@gmail.com, stating the purposes of accessing the documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kosar Zeigham</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 6, Parhoon4 building, Bakhtiary alley, Shirmohammadi st., Pilghoosh st., Bayat st., Shahre-Rey</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>18598-35841</zip>
        <telephone>+98 21 5592 2771</telephone>
        <email>kzeighami76@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alice Khachian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>facculty of nursing and midwifery of iran university of medical sciences, Yasemi street, Vali-e-asr Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>alicekhachian@hotmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with Parkinson's disease whose disease has been confirmed by a neurologist and recorded in their medical records.
Being in the mild and moderate stage of the disease (stages 1, 2, 3 and 4).
Have the ability to read and write, and use smartphone software.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of active diseases such as cancer</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The self-management content provided by the smartphone software was provided from up-to-date, evidence-based medical, nursing, and rehabilitation sources. The accuracy, precision, and validity of this information was confirmed by three faculty members of the School of Nursing and Midwifery of Iran University of Medical Sciences. To conduct this quasi-experimental study, there was a need for an application that could be installed on a smartphone running the Android operating system, which could be used online and offline. The main features of this software are: educational content related to 1- Familiarity with the nature of the disease and motor and non-motor symptoms (general view of the disease) 2- Treatment methods, follow-up recommendations and adherence to medical and pharmaceutical treatment, Monitoring symptoms, 3- Self-management measures in physical symptoms (imbalance, gait disturbance and freezing, brady Keynesian, stiffness and tremor, muscle cramps, dyskinesia, tremor, masked face), 4- Self-management measures in symptoms Non-physical (cardiovascular problems, sleep and fatigue, mood and cognition, memory and concentration, gastrointestinal symptoms, nutrition management, urinary symptoms, self-efficacy, social support), 5- Talk to families (to prepare and improve home conditions , And supporting the family in using the software and accompanying the patient's family in self-management) 6- Frequently asked questions, 7- Contacting the caring nurse (researcher); This software, called "Parkin Seven", was divided into 7 parts and presented 7 recommendations in each part, was provided to the research units. All information in the software is based on scientific evidence and extracted from sites and scientific journals and authoritative books related to the subject and was provided to the clients at once by the smartphone software. Due to dyskinesia and other complications (such as tremors and visual disturbances) related to the disease and restrictions on the use of smartphones, images and text could  magnify. This software is designed to inform patients and their families by providing information about the disease, symptoms, symptom management, treatment, and self-care training in the form of text and photos.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life in parkinson`s disease. Timepoint: assessing quality of life before, 1 and three months after onset of intervention. Method of measurement: Parkinson`s Disease Quality of life Questioner (PDQ-36).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-02</approval_date>
        <contact_name>Iran university of medical sciences, Ethics Committee in Biomedical Research</contact_name>
        <contact_address>No.14, Building no.4, group 114, Moradi street, dolat abad, shahre-rey. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
