<?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>IRCT20230219057454N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-09</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of follow-up care on the psychological consequences of prolonged Covid in the elderly</public_title>
      <acronym></acronym>
      <scientific_title>The impact of the continuous care model on self-care behaviors related to the psychological symptoms of older adults to prevention of long-covid-19 complications</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81464</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Other design features: Allocation to the study groups is such that one group is considered as an intervention and receives the intervention of the continuous care model, and one group is considered as a control and does not receive any intervention, Randomization description: Choosing one of the two health centers No. 1 and 2 in Isfahan by simple random draw, then choosing 4 comprehensive health centers covered by the previously selected center by simple random draw, then from these four centers, using the method A simple random draw of two centers to select control groups and two centers to select intervention groups will be considered.Then, from among the people covered by the centers selected for the control group, 72 people eligible to enter the study (36 people in each center) are placed in the control group using a random number table, And among the people covered by the centers selected for the intervention group, 72 people qualified to enter the study (36 people in each center) were placed in the intervention group using a table of random numbers, Blinding description: All the participants of the control and intervention groups in the study do not know which of the control and intervention groups they belong to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety. Condition 3: Fatigue Syndrom.</hc_freetext>
      <i_freetext>Intervention 1: The intervention of this study is based on the follow-up care model and during face-to-face training classes for the test group. The stages of this model include familiarization, sensitization, control, and evaluation. The first step in the follow-up care model is familiarization, which aims to get to know each other (elderly, family, and educator) and explain the steps of the model. The steps of this stage include introducing the educator to the elderly and family, clarifying the educator's expectations in the study stages, specifying the expectations of the elderly and their family, completing ethical consideration forms, agreeing on the time of training sessions, and conducting a pre-test by filling out the elderly depression, elderly anxiety, and Chalder's fatigue questionnaires by the elderly. The sensitization phase aims to involve the elderly and their families in implementing the follow-up care model in the test group in 4 sessions of 30 to 45 minutes, depending on the level of tolerance and acceptance of the elderly. In the first session, anxiety and depression after Covid in the elderly are discussed with the aim of familiarizing the elderly with these diseases and ways to reduce and control them, and teaching self-care exercises related to them, and appropriate educational videos in this regard will be sent to the elderly via a virtual channel. In the second session, information will be provided to the elderly about weakness and fatigue after Covid and muscle breakdown, its complications and consequences, and ways to reduce and deal with it. In the third and fourth sessions, training will be provided on appropriate physical activity and types of appropriate exercises to strengthen muscles, and educational videos suitable for the elderly to increase physical strength and strengthen muscles, including aerobic, strength, and resistance exercises, will be presented and sent to the elderly. In this stage, the questionnaires for elderly depression, elderly anxiety, and Chalder's fatigue will be completed again by the elderly in the test group. In the control phase, telephone calls will be made in accordance with the care needs of the test group, and the information that has been taught to the elderly in the form of lectures and educational videos during the training sessions will be repeated to them every week in retraining sessions, by telephone or through virtual channels. In the evaluation phase, the evaluation of the desired variables will be carried out using questionnaires. Finally, this phase will end with the completion of the questionnaire at the end of the third month after the intervention, in the test and control groups. The content of the training sessions will also be made available to the elderly in the control group after the completion of the project. Intervention 2: For the control group, the first and last step in the follow-up care model is the familiarization and evaluation problem, which aims to familiarize mutual understanding (elderly, family, and educator) and explain the steps of the model. The steps in this step include introducing the educator to the elderly and family, clarifying the educator's expectations in the study stages, specifying the expectations of the elderly and their family, completing ethical consideration forms, agreeing on the time of the educational sessions, and conducting a pre-test by filling out the questionnaires on elderly depression, elderly anxiety, and Chalder's fatigue by the elderly. In the final step, or evaluation, the steps include evaluating the desired variables using questionnaires. The content of the educational sessions will be made available to the elderly in the control group after the plan is completed.</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 data is potentially shareable after de-identifying individuals.

When:
Access begins after results are printed.

To whom:
All people working in academic, scientific, and industrial sectors are able to receive data.

Conditions:
1- Using information to conduct scientific and research studies 2- Not changing information and observing ethical standards

Where to obtain:
Research project implementers and authors 2- Research assistant of the relevant university and educational institution (Isfahan University of Medical Sciences). Contact information for research project implementers: 1- Ms. Maedeh Khalafai, Address: Isfahan, Third Abshar, 4th Alley of Shahid Tabaeiyan, Prince Park Building, Contact number: 09132748272, Email address: maedeh.kholafai.kh@gmail.com. Mr. Dr. Hossein Shahnazi, Address: Isfahan, Hezar Jerib Street, Isfahan University of Medical Sciences, School of Public Health, Department of Public Health Education, Contact number: 09133360148, Email address: h_shahnazi@yahoo.com.

How to obtain:
After contacting the project implementers and reviewing the applicant's scientific and ethical qualifications, the information will be provided to him/her as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Shahnazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave, School of Health, Isfahan University of Medical Sciences, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>h_shahnazi@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Shahnazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave, School of Health, Isfahan University of Medical Sciences, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 3200</telephone>
        <email>h_shahnazi@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of infection with covid
Age over 60 years
Consent to participate in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from specific mental illnesses including paranoid, schizophrenia, bipolar</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.8</hc_code>
      <hc_code>F06.4</hc_code>
      <hc_code>G93.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other recurrent depressive disorders</hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
      <hc_keyword>Postviral fatigue syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention of this study is based on the follow-up care model and during face-to-face training classes for the test group. The stages of this model include familiarization, sensitization, control, and evaluation. The first step in the follow-up care model is familiarization, which aims to get to know each other (elderly, family, and educator) and explain the steps of the model. The steps of this stage include introducing the educator to the elderly and family, clarifying the educator's expectations in the study stages, specifying the expectations of the elderly and their family, completing ethical consideration forms, agreeing on the time of training sessions, and conducting a pre-test by filling out the elderly depression, elderly anxiety, and Chalder's fatigue questionnaires by the elderly. The sensitization phase aims to involve the elderly and their families in implementing the follow-up care model in the test group in 4 sessions of 30 to 45 minutes, depending on the level of tolerance and acceptance of the elderly. In the first session, anxiety and depression after Covid in the elderly are discussed with the aim of familiarizing the elderly with these diseases and ways to reduce and control them, and teaching self-care exercises related to them, and appropriate educational videos in this regard will be sent to the elderly via a virtual channel. In the second session, information will be provided to the elderly about weakness and fatigue after Covid and muscle breakdown, its complications and consequences, and ways to reduce and deal with it. In the third and fourth sessions, training will be provided on appropriate physical activity and types of appropriate exercises to strengthen muscles, and educational videos suitable for the elderly to increase physical strength and strengthen muscles, including aerobic, strength, and resistance exercises, will be presented and sent to the elderly. In this stage, the questionnaires for elderly depression, elderly anxiety, and Chalder's fatigue will be completed again by the elderly in the test group. In the control phase, telephone calls will be made in accordance with the care needs of the test group, and the information that has been taught to the elderly in the form of lectures and educational videos during the training sessions will be repeated to them every week in retraining sessions, by telephone or through virtual channels. In the evaluation phase, the evaluation of the desired variables will be carried out using questionnaires. Finally, this phase will end with the completion of the questionnaire at the end of the third month after the intervention, in the test and control groups. The content of the training sessions will also be made available to the elderly in the control group after the completion of the project.</i_keyword>
      <i_keyword>For the control group, the first and last step in the follow-up care model is the familiarization and evaluation problem, which aims to familiarize mutual understanding (elderly, family, and educator) and explain the steps of the model. The steps in this step include introducing the educator to the elderly and family, clarifying the educator's expectations in the study stages, specifying the expectations of the elderly and their family, completing ethical consideration forms, agreeing on the time of the educational sessions, and conducting a pre-test by filling out the questionnaires on elderly depression, elderly anxiety, and Chalder's fatigue by the elderly. In the final step, or evaluation, the steps include evaluating the desired variables using questionnaires. The content of the educational sessions will be made available to the elderly in the control group after the plan is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Geriatric Depression Scale scores. Timepoint: Before the intervention, immediately after the intervention, three months after the intervention. Method of measurement: Geriatric Depression Scale.</prim_outcome>
      <prim_outcome>Scores of Chalder Fatigue Questionnaire. Timepoint: Before the intervention, immediately after the intervention, three months after the intervention. Method of measurement: Chalder Fatigue Questionnaire.</prim_outcome>
      <prim_outcome>Geriatric Anxiety Scale scores. Timepoint: Before the intervention, immediately after the intervention, three months after the intervention. Method of measurement: Geriatric Anxiety Scale.</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>2025-01-18</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan city Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
