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/NCT06023810</url>
    </required_header>
    <id_info>
      <org_study_id>IstanbulOkanU-N-EFETURK-001</org_study_id>
      <nct_id>NCT06023810</nct_id>
    </id_info>
    <brief_title>The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers</brief_title>
    <official_title>The Effect of Watson's Human Care Theory-Based Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Okan Univesitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sakarya University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Istanbul Okan Univesitesi</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>
        The rise in diabetes incidence has led to a corresponding increase in diabetes-related&#xD;
        complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial&#xD;
        impacts on patients, the social environment, overall well-being, and nursing procedures.&#xD;
        Given this context, there is a clear necessity for interventions that motivate patients to&#xD;
        adopt beneficial health behaviors and educate them in effectively managing diabetes-related&#xD;
        complications. This study seeks to investigate the impact of Watson's motivational&#xD;
        interviewing method, which is grounded in the human care theory, on enhancing treatment&#xD;
        adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic&#xD;
        foot ulcers.&#xD;
  &#xD;
        Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot&#xD;
        care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals&#xD;
        with diabetic foot ulcers who receive Watson's human care theory-based motivational&#xD;
        interviewing and diabetic foot care education, and those who receive standard education.&#xD;
  &#xD;
        H1: There is a difference in self-efficacy for diabetic foot care between individuals with&#xD;
        diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing&#xD;
        and diabetic foot care education and those who receive standard education.&#xD;
  &#xD;
        H2: There is a difference in diabetic foot care behavior between individuals with diabetic&#xD;
        foot ulcers who receive Watson's human care theory-based motivational interviewing and&#xD;
        diabetic foot care education and those who receive standard education.&#xD;
  &#xD;
        H3: There is a difference in treatment adherence between individuals with diabetic foot&#xD;
        ulcers who receive Watson's human care theory-based motivational interviewing and diabetic&#xD;
        foot care education and those who receive standard education.&#xD;
  &#xD;
        H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who&#xD;
        receive Watson's human care theory-based motivational interviewing and diabetic foot care&#xD;
        education and those who receive standard education.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to the International Diabetes Federation (IDF) data, there are currently 425&#xD;
        million adults worldwide affected by diabetes, and it is projected to increase to 578 million&#xD;
        by 2030 and 700 million by 2045. The increasing prevalence of diabetes has led to a rise in&#xD;
        the frequency of complications arising from diabetes. The escalation in diabetes&#xD;
        complications and their consequences is concerning. There is a need for interventions that&#xD;
        encourage positive changes in health behaviors among patients and teach better management of&#xD;
        diabetes-related complications.&#xD;
  &#xD;
        Diabetic foot ulcer, a challenging complication of diabetes, has significant effects on&#xD;
        physical, mental, social, and economic well-being, leading to reduced quality of life. It&#xD;
        often necessitates prolonged hospitalizations, intensive treatment, and high medical costs.&#xD;
        One of the nursing models frequently preferred today is the Human Care Theory, developed by&#xD;
        Jean Watson between 1975 and 1979. The Human Care Theory is centered around providing quality&#xD;
        care to patients and maintaining effective communication. Motivational Interviewing is a&#xD;
        counseling approach developed by clinical psychologists William R. Miller and Stephen&#xD;
        Rollnick.&#xD;
  &#xD;
        The aim of the study is to investigate the impact of Watson's human care theory-based&#xD;
        motivational interviewing method on treatment adherence, self-efficacy, and satisfaction in&#xD;
        individuals with diabetic foot ulcers. In this study, a randomized controlled&#xD;
        experimental-control group experimental design will be used. The population of the study&#xD;
        consists of patients who applied to Kocaeli Derince Training and Research Hospital Internal&#xD;
        Medicine outpatient clinics between June and October 2023, diagnosed with type 1 and type 2&#xD;
        diabetes mellitus, with first degree diabetic foot wound according to the Wagner&#xD;
        classification. With the power analysis program G-Power 3.1.9.2, the sample size was&#xD;
        calculated as 38 people (76) in each group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wagner's ulcer classification scale</measure>
      <time_frame>at 1 week</time_frame>
      <description>The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to &quot;foot at risk&quot;; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Wagner's ulcer classification scale</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to &quot;foot at risk&quot;; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Wagner's ulcer classification scale</measure>
      <time_frame>at 12 weeks</time_frame>
      <description>The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to &quot;foot at risk&quot;; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diabetic Foot Care Self-Efficacy Scale</measure>
      <time_frame>at 1 week</time_frame>
      <description>It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetic Foot Care Self-Efficacy Scale</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetic Foot Care Self-Efficacy Scale</measure>
      <time_frame>at 12 weeks</time_frame>
      <description>It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication Adherence Report Scale</measure>
      <time_frame>at 1 week</time_frame>
      <description>The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication Adherence Report Scale</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication Adherence Report Scale</measure>
      <time_frame>at 12 weeks</time_frame>
      <description>The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Watson Patient Satisfaction Assessment Form According to Healing Processes</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>The form consists of a total of six questions. The first five questions are scored on a scale of 1 to 7, with responses ranging from 'never' (1) to 'always' (7).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Foot Ulcer, Diabetic</condition>
    <arm_group>
      <arm_group_label>experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Watson's human care theory-based motivational interviewing method</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Watson's human care theory-based motivational interviewing method</intervention_name>
      <description>The Motivational Interviewing Program based on Watson's Theory of Human Caring will be conducted over an 8-week period, with sessions taking place once a week. The initial session will have a duration of 60 minutes, while the subsequent weekly sessions will last for 30 minutes</description>
      <arm_group_label>experimental</arm_group_label>
      <other_name>Pre-post test</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals with clear consciousness,&#xD;
  &#xD;
            -  No communication problems,&#xD;
  &#xD;
            -  Diagnosed with type 1 or type 2 diabetes,&#xD;
  &#xD;
            -  Grade 1 diabetic foot ulcer according to the Wagner classification,&#xD;
  &#xD;
            -  Receiving standard wound care,&#xD;
  &#xD;
            -  Residing in the Kocaeli province,&#xD;
  &#xD;
            -  No musculoskeletal or neurological disorders that could interfere with the study,&#xD;
  &#xD;
            -  Individuals willing to participate and who sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Patients who do not meet the inclusion criteria and those who decline to participate in&#xD;
          the study will not be included.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nida Efetürk</last_name>
      <phone>+905303030850</phone>
      <email>nidaunal@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ayşe Çevirme</last_name>
      <phone>+905363237836</phone>
      <email>acevirme@sakarya.edu.tr</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Okan Univesitesi</investigator_affiliation>
      <investigator_full_name>Nida Efetürk</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Foot</mesh_term>
      <mesh_term>Foot Ulcer</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06023810
  org study id: IstanbulOkanU-N-EFETURK-001
  nct id: NCT06023810
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The rise in diabetes incidence has led to a corresponding increase in diabetes-related
        complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial
        impacts on patients, the social environment, overall well-being, and nursing procedures.
        Given this context, there is a clear necessity for interventions that motivate patients to
        adopt beneficial health behaviors and educate them in effectively managing diabetes-related
        complications. This study seeks to investigate the impact of Watson's motivational
        interviewing method, which is grounded in the human care theory, on enhancing treatment
        adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic
        foot ulcers.
  
        Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot
        care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals
        with diabetic foot ulcers who receive Watson's human care theory-based motivational
        interviewing and diabetic foot care education, and those who receive standard education.
  
        H1: There is a difference in self-efficacy for diabetic foot care between individuals with
        diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing
        and diabetic foot care education and those who receive standard education.
  
        H2: There is a difference in diabetic foot care behavior between individuals with diabetic
        foot ulcers who receive Watson's human care theory-based motivational interviewing and
        diabetic foot care education and those who receive standard education.
  
        H3: There is a difference in treatment adherence between individuals with diabetic foot
        ulcers who receive Watson's human care theory-based motivational interviewing and diabetic
        foot care education and those who receive standard education.
  
        H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who
        receive Watson's human care theory-based motivational interviewing and diabetic foot care
        education and those who receive standard education.
  According to the International Diabetes Federation (IDF) data, there are currently 425
        million adults worldwide affected by diabetes, and it is projected to increase to 578 million
        by 2030 and 700 million by 2045. The increasing prevalence of diabetes has led to a rise in
        the frequency of complications arising from diabetes. The escalation in diabetes
        complications and their consequences is concerning. There is a need for interventions that
        encourage positive changes in health behaviors among patients and teach better management of
        diabetes-related complications.
  
        Diabetic foot ulcer, a challenging complication of diabetes, has significant effects on
        physical, mental, social, and economic well-being, leading to reduced quality of life. It
        often necessitates prolonged hospitalizations, intensive treatment, and high medical costs.
        One of the nursing models frequently preferred today is the Human Care Theory, developed by
        Jean Watson between 1975 and 1979. The Human Care Theory is centered around providing quality
        care to patients and maintaining effective communication. Motivational Interviewing is a
        counseling approach developed by clinical psychologists William R. Miller and Stephen
        Rollnick.
  
        The aim of the study is to investigate the impact of Watson's human care theory-based
        motivational interviewing method on treatment adherence, self-efficacy, and satisfaction in
        individuals with diabetic foot ulcers. In this study, a randomized controlled
        experimental-control group experimental design will be used. The population of the study
        consists of patients who applied to Kocaeli Derince Training and Research Hospital Internal
        Medicine outpatient clinics between June and October 2023, diagnosed with type 1 and type 2
        diabetes mellitus, with first degree diabetic foot wound according to the Wagner
        classification. With the power analysis program G-Power 3.1.9.2, the sample size was
        calculated as 38 people (76) in each group.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Wagner's ulcer classification scale
  time frame: at 1 week
  description: The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
  measure: Wagner's ulcer classification scale
  time frame: at 8 weeks
  description: The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
  measure: Wagner's ulcer classification scale
  time frame: at 12 weeks
  description: The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
  measure: Diabetic Foot Care Self-Efficacy Scale
  time frame: at 1 week
  description: It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
  measure: Diabetic Foot Care Self-Efficacy Scale
  time frame: at 8 weeks
  description: It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
  measure: Diabetic Foot Care Self-Efficacy Scale
  time frame: at 12 weeks
  description: It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
  measure: Medication Adherence Report Scale
  time frame: at 1 week
  description: The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
  measure: Medication Adherence Report Scale
  time frame: at 8 weeks
  description: The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
  measure: Medication Adherence Report Scale
  time frame: at 12 weeks
  description: The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
  measure: Watson Patient Satisfaction Assessment Form According to Healing Processes
  time frame: at 8 weeks
  description: The form consists of a total of six questions. The first five questions are scored on a scale of 1 to 7, with responses ranging from 'never' (1) to 'always' (7).
  arm group label: experimental
  arm group type: Experimental
  description: Watson's human care theory-based motivational interviewing method
  arm group label: control
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Watson's human care theory-based motivational interviewing method
  description: The Motivational Interviewing Program based on Watson's Theory of Human Caring will be conducted over an 8-week period, with sessions taking place once a week. The initial session will have a duration of 60 minutes, while the subsequent weekly sessions will last for 30 minutes
  arm group label: experimental
  other name: Pre-post test
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nida Efetürk
  phone: +905303030850
  email: nidaunal@gmail.com
  last name: Ayşe Çevirme
  phone: +905363237836
  email: acevirme@sakarya.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Okan Univesitesi
  investigator full name: Nida Efetürk
  investigator title: Lecturer
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer
  sharing ipd: No