<?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>IRCT20210327050782N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-15</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mobile health on self-care in older people with myocardial infarction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mobile health on self-care in older people with myocardial infarction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55262</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: First, the health mobile application is installed on the phones of the intervention group and they are taught how to use it. Prior to the intervention, the baseline level of self-care will be assessed using the Self-care of Coronary Heart Disease Inventory (SC-CHDI) questionnaire uploaded to the accompanying health program.Health intervention includes two parts: monitoring and training. The monitoring section includes self-monitoring of the patient in the areas of drug use, examination of cardiac symptoms and nutrition, etc. The interactive and automated capability of this software is such that it provides reminders for timely consumption in the drug consumption section. In case of cardiac symptoms, patients can first receive a recommendation to go to the emergency room, stop the activity, etc. by entering their symptoms in the program. If there is a problem in the areas or have questions in these areas or training programs, they can refer to the question and answer section and send their question to the facilitators and receive the answer.The trainings provided in the health companion program are daily for 4 weeks. Educational content is provided to the elderly using specialized resources after simplification in the form of multimedia, Persian animations, text and audio in the accompanying health program. Different parts of this software help the user in various areas of self-care and receive the necessary information from the user in the form of artificial intelligence and forms and questionnaires. During this period, the control group will receive the usual care of Qazvin Heart Center (Bouali Hospital), which includes a low-fat low-salt diet educational pamphlet, a visit to the heart clinic two weeks after discharge, as well as advice not to consume salt and not to have sex for two It is the week.Immediately after the intervention and 1 month after, the software automatically measures the level of self-care of the participants and sends the results online to the software server and we access the data, Randomization description: Permuted block randomization method will be used in this study to randomize the samples. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers in cases where intermediate analyzes are needed during the sampling process. Number of samples Equal to each of the study groups. The size of all the blocks is equal and we will have 6 groups of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group) in this two-group experiment.
Random allocation software is also used for randomization tools. In addition to simple randomization, these random sequence generation software is able to generate random sequences by blocking method. To hide us from Allocation concealment
We use the method used to perform a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequence Sequentially numbered, sealed, opaque envelopes in
This method records each of the random sequences created on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: first, the health mobile application is installed on the phones of the intervention group and they are taught how to use it. Prior to the intervention, the baseline level of self-care will be assessed using the Self-care of Coronary Heart Disease Inventory (SC-CHDI) questionnaire uploaded to the accompanying health program.Health intervention includes two parts: monitoring and training. The monitoring section includes monitoring the patient in the areas of medication use, cardiac symptoms, and nutrition. The interactive and automated capability of this software is such that in the drug consumption section, it provides reminders for timely use to the patient. In the event of cardiac symptoms, patients can first receive a recommendation to go to the emergency room, stop the activity or reduce the activity by entering their symptoms in the program. If there is a problem in the proposed areas or have a question in the same areas or training programs, they can refer to the question and answer section and send their question to the facilitators and receive the answer.The trainings provided in the health companion program are daily for 4 weeks. Educational content is provided to the elderly using specialized resources after simplification in the form of multimedia, Persian animations, text and audio in the accompanying health program. Different parts of this software help the user in various areas of self-care and receive the necessary information from the user in the form of artificial intelligence and forms and questionnaires.Immediately after the intervention and 1 month after, the software automatically measures the level of self-care of the participants and sends the results online to the software server and we access the data.It should be noted that the intervention group will also receive the usual care of the heart center. Intervention 2: Control group: control group will receive the usual care of Qazvin Heart Center (Bouali Hospital), which includes a low-fat low-salt diet educational pamphlet, a visit to a heart clinic two weeks after discharge, as well as advice not to consume salt and not to have sex for up to two weeks.Immediately after participating in this study and one month later, the level of self-care will be asked of them and will be examined with other data.</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:
After deleting the name and mobile number and address of the participants, the rest of the data can be published.

When:
Immediately after the publication of the results data can be published

To whom:
All researchers

Conditions:
Unconditional

Where to obtain:
Contact the following email to receive data : arashghisvand@gmail.com

How to obtain:
Unconditional

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Ghiasvand Mohammad Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Qazvin University of Medical Sciences, Shahid Bahonar Boulevard</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>arashghisvand@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Ghiasvand Mohammad Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Qazvin University of Medical Sciences, Shahid Bahonar Boulevard</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>arashghisvand@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60 years old and older
A history of myocardial infarction for at least the last 6 months
Has the mental capacity to communicate
Patient consent to participate in the study
Having a smartphone (Android)
Have minimum ability to read and write</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Catching Heart failure
Hearing or speech impairment that prevents communication
Cognitive impairment such as Alzheimer's and amnesia
Having debilitating diseases such as stroke and neurological diseases, etc.
Occurrence of severe stressful event during the study or 3 months before
Loss of smartphone
Dissatisfaction with continuing the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: first, the health mobile application is installed on the phones of the intervention group and they are taught how to use it. Prior to the intervention, the baseline level of self-care will be assessed using the Self-care of Coronary Heart Disease Inventory (SC-CHDI) questionnaire uploaded to the accompanying health program.Health intervention includes two parts: monitoring and training. The monitoring section includes monitoring the patient in the areas of medication use, cardiac symptoms, and nutrition. The interactive and automated capability of this software is such that in the drug consumption section, it provides reminders for timely use to the patient. In the event of cardiac symptoms, patients can first receive a recommendation to go to the emergency room, stop the activity or reduce the activity by entering their symptoms in the program. If there is a problem in the proposed areas or have a question in the same areas or training programs, they can refer to the question and answer section and send their question to the facilitators and receive the answer.The trainings provided in the health companion program are daily for 4 weeks. Educational content is provided to the elderly using specialized resources after simplification in the form of multimedia, Persian animations, text and audio in the accompanying health program. Different parts of this software help the user in various areas of self-care and receive the necessary information from the user in the form of artificial intelligence and forms and questionnaires.Immediately after the intervention and 1 month after, the software automatically measures the level of self-care of the participants and sends the results online to the software server and we access the data.It should be noted that the intervention group will also receive the usual care of the heart center.</i_keyword>
      <i_keyword>Control group: control group will receive the usual care of Qazvin Heart Center (Bouali Hospital), which includes a low-fat low-salt diet educational pamphlet, a visit to a heart clinic two weeks after discharge, as well as advice not to consume salt and not to have sex for up to two weeks.Immediately after participating in this study and one month later, the level of self-care will be asked of them and will be examined with other data.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care. Timepoint: (Before the intervention) and 30, 60 days after the intervention. Method of measurement: Self-care Questionnaire of Coronary Heart Disease Inventory (SC-CHDI).</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-03</approval_date>
        <contact_name>Research Ethics Committees of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Beheshti Blvd. Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
