<?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>IRCT20180930041185N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-23</date_registration>
      <primary_sponsor>Faculty of Medical Sciences, Tarbiat Modares University</primary_sponsor>
      <public_title>Effectiveness of “care transition intervention” plan in the older</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of “care transition intervention” plan and routine care plan on health-related outcomes in the older adults with multiple chronic condition</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63320</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sample allocation is done randomly (lottery) in two study groups, so that an allocation protocol is created using the permuted block randomization technique (Pocock, 2013). Since the sample framework or patient list is not clear and available before admission, 90 cards are first numbered for the 90 participants and placed in a basket. The cards are then randomly removed from the basket and placed in two intervention and control envelopes. Then, the eligible patients are assigned a number based on the order of admission to the hospital, and then, based on their placement in the replaced blocks, they are selected sequentially and placed in an intervention group or a control group. This ensures the random allocation of participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Congestive Heart Failure. Condition 2: Coronary Artery Disease. Condition 3: Hypertension. Condition 4: Cardiac Arrhythmia. Condition 5: Chronic Obstructive Pulmonary Disease. Condition 6: Diabetes. Condition 7: Peripheral Vascular Disease.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group: The intervention in the experimental group is based on the care transition intervention model, which is the duration of the intervention from the time of admission to the hospital to 30 days after discharge.The care transition intervention is based on four pillars or conceptual areas, which include 1- medication self-management, 2- a patient-centered record kept by the patient to facilitate information transfer, 3- Follow-up (completing the patient's follow-up visits with the primary care provider Or other health professionals, suggest follow-up visits to the patient and support the patient to coordinate the time of the next visit with health professionals if necessary by the nurse), and 4- List of warning signs (red flags) indicating worsening of the condition and instructions about how to react to them. The above four conceptual areas  are operational through two strategic mechanisms including personal health record building and visits and telephone calls by the researcher (coach transition), to encourage the elderly and their caregivers to play a more active role during the care transition and strengthen coordination and continuity of care throughout care facilities. In the present study, the role of transition instructor is assumed by the researcher who has a master's degree in geriatric nursing. In general, in three stages: 1- hospital visit, 2- home visit and 3- at least three telephone calls, the coach transition will perform the care  transition intervention with the participation of the patient and the caregiver. Intervention 2: Control group: In the control group, the researcher does not intervene during the research period. The control group receives the same routine hospital care. Routine care is such that the nurse provides the patient with a discharge instruction sheet at the time of discharge. The contents of the discharge education leaflet include information about the patient's medication (when and how to take the medication), care at home, nutrition, the time of the next visit to the clinic, and the time of receiving the test / pathology results. The discharge form is a single format and stereotype and does not include specific considerations and content about the elderly and other chronic illnesses that were not the direct cause of hospitalization. The explanations and trainings mentioned in the discharge form are also provided orally to the patient on the day of discharge from the hospital. Due to the completion and presentation of the discharge training sheet, comprehensive and complete information regarding the items mentioned in the discharge training sheet and other items such as side effects of medications and warning signs appropriate to the patient's condition and disease are not provided to the patient and caregivers and the information provided is brief. After the patient is discharged from the hospital, no special care and follow-up action is taken by the hospital for patients and caregivers.</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 Needless to say, some of this data will come as a demographic data that is important for interpreting the findings in the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Eesa Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bridge Nasr (Gisha), Tarbiat Modares University, Faculty of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3550</telephone>
        <email>mohamade@modares.ac.ir</email>
        <affiliation>Faculty of Medical Sciences, Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Eesa Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paul Nasr (Gisha), Tarbiat Modares University, Faculty of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3550</telephone>
        <email>mohamade@modares.ac.ir</email>
        <affiliation>Faculty of Medical Sciences, Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60 years and older
Alertness and ability to communicate
Having a normal cognitive status based on the Abbreviated Mental Test (score 7 and above)
Having at least two chronic condition (Congestive Heart Failure, Coronary Artery Disease, Hypertension, Cardiac Arrhythmia, Chronic Obstructive Pulmonary Disease, Diabetes, Peripheral Vascular Disease)
Having a telephone
Being transported home after hospital discharge
Family caregivers must be at least Be 18 years old
Willingness to continue participating in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Evidence of mental illness and dementia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.42</hc_code>
      <hc_code>I25.1</hc_code>
      <hc_code>I87.3</hc_code>
      <hc_code>I49.9</hc_code>
      <hc_code>J44.9</hc_code>
      <hc_code>E08</hc_code>
      <hc_code>I73.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic combined systolic (congestive) and diastolic (congestive) heart failure</hc_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
      <hc_keyword>Chronic venous hypertension (idiopathic)</hc_keyword>
      <hc_keyword>Cardiac arrhythmia, unspecified</hc_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease, unspecified</hc_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
      <hc_keyword>Peripheral vascular 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>Experimental group: The intervention in the experimental group is based on the care transition intervention model, which is the duration of the intervention from the time of admission to the hospital to 30 days after discharge.The care transition intervention is based on four pillars or conceptual areas, which include 1- medication self-management, 2- a patient-centered record kept by the patient to facilitate information transfer, 3- Follow-up (completing the patient's follow-up visits with the primary care provider Or other health professionals, suggest follow-up visits to the patient and support the patient to coordinate the time of the next visit with health professionals if necessary by the nurse), and 4- List of warning signs (red flags) indicating worsening of the condition and instructions about how to react to them. The above four conceptual areas  are operational through two strategic mechanisms including personal health record building and visits and telephone calls by the researcher (coach transition), to encourage the elderly and their caregivers to play a more active role during the care transition and strengthen coordination and continuity of care throughout care facilities. In the present study, the role of transition instructor is assumed by the researcher who has a master's degree in geriatric nursing. In general, in three stages: 1- hospital visit, 2- home visit and 3- at least three telephone calls, the coach transition will perform the care  transition intervention with the participation of the patient and the caregiver.</i_keyword>
      <i_keyword>Control group: In the control group, the researcher does not intervene during the research period. The control group receives the same routine hospital care. Routine care is such that the nurse provides the patient with a discharge instruction sheet at the time of discharge. The contents of the discharge education leaflet include information about the patient's medication (when and how to take the medication), care at home, nutrition, the time of the next visit to the clinic, and the time of receiving the test / pathology results. The discharge form is a single format and stereotype and does not include specific considerations and content about the elderly and other chronic illnesses that were not the direct cause of hospitalization. The explanations and trainings mentioned in the discharge form are also provided orally to the patient on the day of discharge from the hospital. Due to the completion and presentation of the discharge training sheet, comprehensive and complete information regarding the items mentioned in the discharge training sheet and other items such as side effects of medications and warning signs appropriate to the patient's condition and disease are not provided to the patient and caregivers and the information provided is brief. After the patient is discharged from the hospital, no special care and follow-up action is taken by the hospital for patients and caregivers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rehospitalization. Timepoint: The beginning of the study (Before intervention), 30, 90 and 180 days after discharge. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: The beginning of the study (Before intervention), 30, 90 and 180 days after discharge. Method of measurement: World Health Organization Quality of Life Questionnaire, older adults Edition.</sec_outcome>
      <sec_outcome>Activity of Daily Living. Timepoint: The beginning of the study (Before intervention), 30, 90 and 180 days after discharge. Method of measurement: Activities of Daily Living Questionnaire.</sec_outcome>
      <sec_outcome>Instrumental Activity of Daily Living. Timepoint: The beginning of the study (Before intervention), 30, 90 and 180 days after discharge. Method of measurement: Instrumental Activity of Daily Living Questionnaire.</sec_outcome>
      <sec_outcome>Depression. Timepoint: The beginning of the study (Before intervention), 30, 90 and 180 days after discharge. Method of measurement: Geriatric Depression Scale.</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>Faculty of Medical Sciences, Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-27</approval_date>
        <contact_name>Research Ethics Committees of Tarbiat Modares University</contact_name>
        <contact_address>Bridge Nasr, Jalal Al-e Ahmad, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
