<?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>IRCT20191011045056N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-18</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Promoting self-care, health literacy and social capital in older adults</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a complex multicomponent intervention on self-care, health literacy and social capital among older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43018</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly Quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study is a community-based study with multiple and varied components implemented in a multifaceted intervention program. Intervention and content of the sessions are based on a similar study protocol that was previously published in BMC Public Health (2018). the intervention is described with the TIDieR Guidelines below. It is designed to enhance social support and participation (social capital), Self-care, and health literacy in the elderly as mediating factors between social determinants and health outcomes, and with the potential to improve the quality of life and well-being of the elderly. Intervention materials and methods have been slightly adjusted to fit our country's cultural and indigenous conditions. The intervention program consists of 12 weekly and two-hour sessions with the following topics:  Sessions (contents, materials and procedures)  1. Health and Self Care: Introducing the Program,  Participants introduce themselves ,  group discussion  using photos of self-care daily activities, asking the group to bring a personal item from home  the next meeting, creating a wall newspaper of member paintings, handicrafts,  writing and ... 2.  Physical Activity: Participants talk about the personal object they brought from home, discussing and setting a specific goal of daily living achievable during the week. Identifying appropriate locations for physical activity using local mapping, short instruction and discussing about the benefits and limitations of physical activity, agreeing on the destination for a group walk in the next session 3. Local First Walk: Group does a Walk with Origins Start and end at the health center and do physical activity in a place like a park or gym 4. Emotional health: Talk about achieving personal goals. Short tutorials on problem-solving techniques, group discussion on coping strategies, a relaxation exercise 5. Healthy eating habits: short tutorials on healthy and inexpensive eating tips, group discussion on eating habits, and nutrition tips Cheaper and and about the places where they shop. Agree on the market or store for local circulation next week 6. Second local circulation: Groups visit the local supermarket. During the meeting they discuss their eating habits and preferences for shopping.  7. Loneliness and Social relationships: A brief tutorial on concepts of loneliness and social relationships, group discussion  focusing on thoughts and perceptions of loneliness and social relationships. Divide the group into subgroups to create keywords stories about social communication. 8. Community Participation: Reading a story about a woman participating in local community activities by a member aloud, identifying important local community activities using the local map and discussing them, group discussion on the limitations and benefits of social participation, Agree on an important social place in the area for the next visit 9. Third Local Circle: The group visits an important local place, one of the site's operators explains to the group about the place and its activities. Groups are encouraged to participate in social activities.10. Personal autonomy: A brief tutorial on the concept of personal autonomy, group discussion on personal autonomy, discussion of the practical case put forward by the trainer. 11. Get in touch with health professionals: A video showing how to prepare for a medical encounter. Describe the thoughts and feelings of the group members when meeting a health care provider and their personal knowledge of health resources in the community 12. Group Discussion Final Session: Expressing People's Thoughts and Feelings about the Program, Creating, and Donating an Imaginary Gift to Another Participant , The group shares a farewell meal.  The intervention team consists of four health care providers and one physician (with experience in health care) will be previously trained as group facilitators by the research team during a two-day workshop  based on the instructional guide.  Intervention is carried out at two urban health sites  including 12 weekly and two hour sessions and is conducted for two groups of 20.  Each participant receives a code and completes the questionnaires at the beginning of the study by interviewing them. Outcome interviewers are selected from health care providers who are not involved in the intervention. They receive the necessary training on interviewing and filling out questionnaires before they start. One or two health care providers as observers record  quantitative and qualitative measures of implementation such as fidelity and adherence. Intervention 2: Control group: the participants from  control group will receive the usual  universal healthcare services available in health centers. At the end of the program, they are suggested to enter the intervention group in the next period of program implementation.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Motamedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Isfahan University Of Medical Sciences, Hezar Jerib street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7346181764</zip>
        <telephone>+98 31 3792 8145</telephone>
        <email>N_motamedi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Motamedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Isfahan University Of Medical Sciences, Hezar Jerib street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 8145</telephone>
        <email>N_motamedi@med.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>
    </countries>
    <criteria>
      <inclusion_criteria>They are community-dwelling aged 60 year or above.
They have minimum literacy skills.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>They need help to go to the primary health care centres (PCC).
They have cognitive impairment or  dementia.
They have a medical condition that contraindicates physical activity.
They have any severe mental health problem that hinders participation in a group participation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z76.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Person encountering health services in unspecified circumstances</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study is a community-based study with multiple and varied components implemented in a multifaceted intervention program. Intervention and content of the sessions are based on a similar study protocol that was previously published in BMC Public Health (2018). the intervention is described with the TIDieR Guidelines below. It is designed to enhance social support and participation (social capital), Self-care, and health literacy in the elderly as mediating factors between social determinants and health outcomes, and with the potential to improve the quality of life and well-being of the elderly. Intervention materials and methods have been slightly adjusted to fit our country's cultural and indigenous conditions. The intervention program consists of 12 weekly and two-hour sessions with the following topics:  Sessions (contents, materials and procedures)  1. Health and Self Care: Introducing the Program,  Participants introduce themselves ,  group discussion  using photos of self-care daily activities, asking the group to bring a personal item from home  the next meeting, creating a wall newspaper of member paintings, handicrafts,  writing and ... 2.  Physical Activity: Participants talk about the personal object they brought from home, discussing and setting a specific goal of daily living achievable during the week. Identifying appropriate locations for physical activity using local mapping, short instruction and discussing about the benefits and limitations of physical activity, agreeing on the destination for a group walk in the next session 3. Local First Walk: Group does a Walk with Origins Start and end at the health center and do physical activity in a place like a park or gym 4. Emotional health: Talk about achieving personal goals. Short tutorials on problem-solving techniques, group discussion on coping strategies, a relaxation exercise 5. Healthy eating habits: short tutorials on healthy and inexpensive eating tips, group discussion on eating habits, and nutrition tips Cheaper and and about the places where they shop. Agree on the market or store for local circulation next week 6. Second local circulation: Groups visit the local supermarket. During the meeting they discuss their eating habits and preferences for shopping.  7. Loneliness and Social relationships: A brief tutorial on concepts of loneliness and social relationships, group discussion  focusing on thoughts and perceptions of loneliness and social relationships. Divide the group into subgroups to create keywords stories about social communication. 8. Community Participation: Reading a story about a woman participating in local community activities by a member aloud, identifying important local community activities using the local map and discussing them, group discussion on the limitations and benefits of social participation, Agree on an important social place in the area for the next visit 9. Third Local Circle: The group visits an important local place, one of the site's operators explains to the group about the place and its activities. Groups are encouraged to participate in social activities.10. Personal autonomy: A brief tutorial on the concept of personal autonomy, group discussion on personal autonomy, discussion of the practical case put forward by the trainer. 11. Get in touch with health professionals: A video showing how to prepare for a medical encounter. Describe the thoughts and feelings of the group members when meeting a health care provider and their personal knowledge of health resources in the community 12. Group Discussion Final Session: Expressing People's Thoughts and Feelings about the Program, Creating, and Donating an Imaginary Gift to Another Participant , The group shares a farewell meal.  The intervention team consists of four health care providers and one physician (with experience in health care) will be previously trained as group facilitators by the research team during a two-day workshop  based on the instructional guide.  Intervention is carried out at two urban health sites  including 12 weekly and two hour sessions and is conducted for two groups of 20.  Each participant receives a code and completes the questionnaires at the beginning of the study by interviewing them. Outcome interviewers are selected from health care providers who are not involved in the intervention. They receive the necessary training on interviewing and filling out questionnaires before they start. One or two health care providers as observers record  quantitative and qualitative measures of implementation such as fidelity and adherence.</i_keyword>
      <i_keyword>Control group: the participants from  control group will receive the usual  universal healthcare services available in health centers. At the end of the program, they are suggested to enter the intervention group in the next period of program implementation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sُُelf-care. Timepoint: Self-care measurement at baseline (before intervention), immediately after, and 3 months after intervention. Method of measurement: Self-Care Questionnaire for the Elderly.</prim_outcome>
      <prim_outcome>Health literacy. Timepoint: At baseline (before intervention), immediately, and 3 months after intervention. Method of measurement: Health Literacy for Iranian Adults (HELIA).</prim_outcome>
      <prim_outcome>Social Capital. Timepoint: At baseline (before intervention), immediately, and 3 months after intervention. Method of measurement: Onyx and Bullen Social Capital Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: At baseline (before intervention), immediately, and 3 months after intervention. Method of measurement: short form 12 quality-of-life questionnaire (SF-12).</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>2019-03-07</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University Of Medical Sciences,Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
