xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05994651</url>
    </required_header>
    <id_info>
      <org_study_id>Tidal Model</org_study_id>
      <nct_id>NCT05994651</nct_id>
    </id_info>
    <brief_title>The Effect of the Tidal Model in Diabetes Patients</brief_title>
    <official_title>Evaluation of the Effect of Tidal Model on Distress, Self-Management and Psychological Well-Being in Individuals With Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Osmaniye Korkut Ata University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Osmaniye Korkut Ata University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aim:&#xD;
  &#xD;
        In this study, it was aimed to evaluate the effect of the tidal model on distress,&#xD;
        self-management and psychological well-being in individuals with diabetes. It is thought that&#xD;
        this study will contribute to the literature, nursing profession and patients with diabetes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Population of the Research: The population of the research will be individuals who applied to&#xD;
        Osmaniye State Hospital and were diagnosed with Diabetes at least 6 months ago. The sample of&#xD;
        the research: The sample of the research is; In calculating the number of samples, the study&#xD;
        of Savaşan and Çam named 'The Effect of the Psychiatric Nursing Approach Based on the Tidal&#xD;
        Model on Coping and Self-esteem in People with Alcohol Dependency: A Randomized Trial' was&#xD;
        taken as reference.At the end of the Tidal Model application, the effect size was calculated&#xD;
        as 0.652 based on the difference between the self-esteem scores. In this context; A power of&#xD;
        0.80 and a margin of error of 0.05 for type 1 were taken, and it was deemed appropriate to&#xD;
        take a total of 60 individuals, with a sample size of 30 individuals in the intervention and&#xD;
        control groups. Sample size is based on independent t-test. It was decided to include more&#xD;
        than 20% of the sample number calculated in terms of losses during the implementation of the&#xD;
        study and statistical analysis. Accordingly, 36 intervention and 36 control groups will&#xD;
        beResearch data&#xD;
  &#xD;
        Literature-based Personal Information Form will be collected using Diabetes Distress Scale&#xD;
        Type 2 Diabetes Self-Management Scale Psychological Well-Being Scale. In order to conduct the&#xD;
        study, the approval of the Clinical Research Ethics Committee, written permission from the&#xD;
        institution and written permission from the participants were obtained.In the study, in which&#xD;
        the psychiatric nursing approach based on the Tidal Model is applied, approximately 6 and 10&#xD;
        individual interviews will be held with the individuals in the experimental group in addition&#xD;
        to the routine treatment and follow-up in the Osmaniye State Hospital training hall. The&#xD;
        control group will continue to receive routine treatment and follow-up. In order to provide&#xD;
        individualized care to the individuals in the experimental group, initiatives will be&#xD;
        implemented by starting individual interviews and in line with the goals of the individuals&#xD;
        and the objectives of the research. Considering the basic processes of the Tidal Model,&#xD;
        stages of care, basic approach and Tidal competencies, an interview plan including the&#xD;
        details of the interviews with diabetes patients will be created and a meeting plan will be&#xD;
        made with One-to-One Sessions. It will be concluded with an average of 6 and 10 interviews,&#xD;
        depending on the situation of the individuals. tried to be formed. The number of samples was&#xD;
        calculated in the G*Power 3.1 program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">September 10, 2023</completion_date>
    <primary_completion_date type="Actual">July 10, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated.</measure>
      <time_frame>up to 6-10 weeks</time_frame>
      <description>The DDS is a 17-item psychological measurement tool that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) to reflect distress experienced over the last month. The total score is calculated by dividing the sum of the answers by 17. A score of ≥3 is defined as T2DM-related distress. There are four subscales and subscale scores are also calculated by dividing the sum of subscale answers to the total question count of the subscale. Subscales are as follows: the emotional burden subscale with 5 questions, the physician-related distress subscale with 4 questions, the regimen-related distress subscale with 5 questions, and the interpersonal distress subscale with 3 questions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of using the tidal model on the self-management status of individuals with diabetes will be evaluated.</measure>
      <time_frame>up to 6-10 weeks</time_frame>
      <description>There are 8 items in the original scale of the Diabetes Self-Management Perception Scale. High participation in these items indicates low self-efficacy. For this reason, the 3 items mentioned were reverse scored compared to the other items. The lowest score that can be obtained from the scale is 7, and the highest score is 35. A high total score indicates that the individual has good awareness of diabetes management</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of using the tidal model on the psychological well-being of individuals with diabetes will be evaluated.</measure>
      <time_frame>up to 6-10 weeks</time_frame>
      <description>The scale is an 8-item 7-point Likert-type (1=totally disagree, 7=totally agree) self-assessment scale. High scores indicate higher psychological well-being.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Diabetic</condition>
    <arm_group>
      <arm_group_label>Tidal Model improvement model</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the research objectives.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tidal Model Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Individuals in the control group will continue their lives.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Tidal Model improvement model</intervention_name>
      <description>st interview Pre-assessment Application of measurement tools&#xD;
  nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions&#xD;
  4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process</description>
      <arm_group_label>Tidal Model improvement model</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Diagnosed with diabetes for at least 6 months, Individuals aged 18 and over will be&#xD;
          included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with any psychiatric or neurological disorder that would prevent adequate&#xD;
          communication will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ejdane Coşkun</last_name>
      <role>Principal Investigator</role>
      <affiliation>Korkut Ata University Osmaniye, Center, Türkiye, 80000</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ayşe İNEL MANAV</last_name>
      <role>Principal Investigator</role>
      <affiliation>Korkut Ata University Osmaniye, Center, Türkiye, 80000</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Derya Atik</last_name>
      <role>Principal Investigator</role>
      <affiliation>Korkut Ata University Osmaniye, Center, Türkiye, 80000</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Türkiye</name>
        <address>
          <city>Osmaniye</city>
          <state>Korkut Ata University</state>
          <zip>80000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Osmaniye Korkut Ata University</investigator_affiliation>
      <investigator_full_name>Ejdane Coskun</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Diabetes disease</keyword>
    <keyword>Psychiatric Nursing</keyword>
    <keyword>Tidal Model</keyword>
    <keyword>Psychological well-being</keyword>
    <keyword>Distress</keyword>
    <keyword>Self-Management</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Don't share</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05994651
  org study id: Tidal Model
  nct id: NCT05994651
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aim:
  
        In this study, it was aimed to evaluate the effect of the tidal model on distress,
        self-management and psychological well-being in individuals with diabetes. It is thought that
        this study will contribute to the literature, nursing profession and patients with diabetes.
  Population of the Research: The population of the research will be individuals who applied to
        Osmaniye State Hospital and were diagnosed with Diabetes at least 6 months ago. The sample of
        the research: The sample of the research is; In calculating the number of samples, the study
        of Savaşan and Çam named 'The Effect of the Psychiatric Nursing Approach Based on the Tidal
        Model on Coping and Self-esteem in People with Alcohol Dependency: A Randomized Trial' was
        taken as reference.At the end of the Tidal Model application, the effect size was calculated
        as 0.652 based on the difference between the self-esteem scores. In this context; A power of
        0.80 and a margin of error of 0.05 for type 1 were taken, and it was deemed appropriate to
        take a total of 60 individuals, with a sample size of 30 individuals in the intervention and
        control groups. Sample size is based on independent t-test. It was decided to include more
        than 20% of the sample number calculated in terms of losses during the implementation of the
        study and statistical analysis. Accordingly, 36 intervention and 36 control groups will
        beResearch data
  
        Literature-based Personal Information Form will be collected using Diabetes Distress Scale
        Type 2 Diabetes Self-Management Scale Psychological Well-Being Scale. In order to conduct the
        study, the approval of the Clinical Research Ethics Committee, written permission from the
        institution and written permission from the participants were obtained.In the study, in which
        the psychiatric nursing approach based on the Tidal Model is applied, approximately 6 and 10
        individual interviews will be held with the individuals in the experimental group in addition
        to the routine treatment and follow-up in the Osmaniye State Hospital training hall. The
        control group will continue to receive routine treatment and follow-up. In order to provide
        individualized care to the individuals in the experimental group, initiatives will be
        implemented by starting individual interviews and in line with the goals of the individuals
        and the objectives of the research. Considering the basic processes of the Tidal Model,
        stages of care, basic approach and Tidal competencies, an interview plan including the
        details of the interviews with diabetes patients will be created and a meeting plan will be
        made with One-to-One Sessions. It will be concluded with an average of 6 and 10 interviews,
        depending on the situation of the individuals. tried to be formed. The number of samples was
        calculated in the G*Power 3.1 program.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: 1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated.
  time frame: up to 6-10 weeks
  description: The DDS is a 17-item psychological measurement tool that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) to reflect distress experienced over the last month. The total score is calculated by dividing the sum of the answers by 17. A score of ≥3 is defined as T2DM-related distress. There are four subscales and subscale scores are also calculated by dividing the sum of subscale answers to the total question count of the subscale. Subscales are as follows: the emotional burden subscale with 5 questions, the physician-related distress subscale with 4 questions, the regimen-related distress subscale with 5 questions, and the interpersonal distress subscale with 3 questions.
  measure: The effect of using the tidal model on the self-management status of individuals with diabetes will be evaluated.
  time frame: up to 6-10 weeks
  description: There are 8 items in the original scale of the Diabetes Self-Management Perception Scale. High participation in these items indicates low self-efficacy. For this reason, the 3 items mentioned were reverse scored compared to the other items. The lowest score that can be obtained from the scale is 7, and the highest score is 35. A high total score indicates that the individual has good awareness of diabetes management
  measure: The effect of using the tidal model on the psychological well-being of individuals with diabetes will be evaluated.
  time frame: up to 6-10 weeks
  description: The scale is an 8-item 7-point Likert-type (1=totally disagree, 7=totally agree) self-assessment scale. High scores indicate higher psychological well-being.
  arm group label: Tidal Model improvement model
  arm group type: Experimental
  description: In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the research objectives.
  arm group label: Tidal Model Control Group
  arm group type: No Intervention
  description: Individuals in the control group will continue their lives.
  intervention type: Behavioral
  intervention name: Tidal Model improvement model
  description: st interview Pre-assessment Application of measurement tools
  nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions
  4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process
  arm group label: Tidal Model improvement model
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ejdane Coşkun
  role: Principal Investigator
  affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
  last name: Ayşe İNEL MANAV
  role: Principal Investigator
  affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
  last name: Derya Atik
  role: Principal Investigator
  affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Osmaniye Korkut Ata University
  investigator full name: Ejdane Coskun
  investigator title: Lecturer
  sharing ipd: No
  ipd description: Don't share