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/NCT06037369</url>
    </required_header>
    <id_info>
      <org_study_id>NMRPD1N0241</org_study_id>
      <secondary_id>NSTC112-2314-B-182-028</secondary_id>
      <nct_id>NCT06037369</nct_id>
    </id_info>
    <brief_title>The Short Message-based Customized Standardized</brief_title>
    <official_title>The Effectiveness of a Short Message-based Customized Standardized Education Program in Promoting Wound Healing and Quality of Life of Patients With Diabetic Foot Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chang Gung Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chang Gung Memorial Hospital</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 purpose of this study is to develop a short message-based customized standardized&#xD;
        diabetic foot ulcer patient education program, and to test the effect of the program on&#xD;
        diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of&#xD;
        life. The short message-based customized standardized patient education program combines&#xD;
        several smartphone message-based standardized educational contents to construct a customized&#xD;
        patient education program which is according to the needs of patients, thus providing&#xD;
        individualized patient education in a timely manner&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to develop a short message-based customized standardized&#xD;
        diabetic foot ulcer patient education program, and to test the effect of the program on&#xD;
        diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of&#xD;
        life.&#xD;
  &#xD;
        The short message-based customized standardized patient education program combines several&#xD;
        smartphone message-based standardized educational contents to construct a customized patient&#xD;
        education program which is according to the needs of patients, thus providing individualized&#xD;
        patient education in a timely manner. The short message-based customized standardized patient&#xD;
        education program may improve the diabetic foot ulcers self-management behavior and the&#xD;
        self-efficacy on diabetic foot ulcers self-management, thereby promoting wound healing and&#xD;
        improving quality of life.&#xD;
  &#xD;
        In the first year, a customized standardized patient education program will be developed, and&#xD;
        then the effectiveness evaluation will be carried out. A randomized controlled study design&#xD;
        will be adopted, and 178 outpatients with diabetic foot ulcers are expected to be recruited.&#xD;
        The control group will receive routine care, while the experimental group will receive a&#xD;
        short message-based customized standardized diabetic foot ulcer patient education program&#xD;
        after their outpatient visits. Subjects will be followed up for eight weeks, and the&#xD;
        generalized estimating equation (GEE) will be used to evaluate the effectiveness of the&#xD;
        intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 14, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2026</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>
      <intervention_model_description>Participants are assigned to two groups in parallel for the duration of the study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wound healing</measure>
      <time_frame>baseline and after four and eight weeks</time_frame>
      <description>In this study, whether the percentage foot ulcer area reduction (PAR) reaches 50% after four weeks and whether DFU is healed is used as the evaluation index. We used the following formula to calculate the percentage area reduction (PAR): PAR = (primary wound area - secondary area / primary area) × 100</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DFU Quality of life</measure>
      <time_frame>Baseline and after four and eight weeks</time_frame>
      <description>Questionnaire on quality of life with chronic wounds (Wound QoL-17) will be used at four weeks and eight weeks after baseline to evaluate the change of QOL. Blome et al. (2014) Questionnaire on quality of life with chronic wound (Wound-QoL) has 17 items to measure the quality of life of patients with chronic wounds. Using the 5-point Likert scale, the patients were asked to report their chronic wounds in the past seven days, ranging from 0 (not at all) to 4 (very affected), with higher average scores indicating poorer quality of life. The total DFUSMB score ranges 0-68.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>DFU self-management behavior</measure>
      <time_frame>Baseline and after four and eight weeks</time_frame>
      <description>In this study, Chin et al. (2019) &quot;DFU Self-Management Behavior Scale&quot; (DFUSMB), will be used to measure DFU self-management behavior at four weeks and eight weeks after baseline.&#xD;
  The DFUSMB measures behaviors that promote wound healing and prevent wound deterioration with 18 items in total, using the five-point Likert scale. &quot;Never&quot;, &quot;Seldom&quot;, &quot;Sometimes&quot;, &quot;Often&quot; and &quot;Always&quot; are scored from 1 to 5 respectively. Reverse questions are scored in reverse, and the higher the total score, the better the self-management behavior of DFUs. The total DFUSMB score ranges 18-90.The DFUSMB has sufficient reliability and validity (Chin et al., 2019).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DFU self-management self-efficacy</measure>
      <time_frame>Baseline and after four and eight weeks</time_frame>
      <description>The researcher developed the Diabetic Foot Ulcer Self-Efficacy Scale (DFUMSE) consisting of 17 self-constructed questions to measure self-efficacy in diabetic foot ulcer management. A scoring system of 0 to 10 points is used, where 0 points indicate no confidence at all, and 10 points indicate complete confidence. Higher scores indicate higher self-efficacy. The total DFUMSE score ranges 0-170.&#xD;
  Two questions were used to measure self-efficacy for foot self-care:&#xD;
  &quot;I am confident that I can: Check the soles and toe gaps of my feet every day by myself (or with someone's assistance).&quot; &quot;I am confident that I can: Apply lotion or Vaseline to my feet every day by myself (or with someone's assistance) when the skin on my feet is dry.&quot; Both questions were scored using an 11-point scale, with 0 indicating no confidence at all and 10 indicating complete confidence. Higher scores reflect higher self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetes self-care behaviors</measure>
      <time_frame>Baseline and after four and eight weeks</time_frame>
      <description>The summary of diabetes self-care activity questionnaire (SDSCA) In this study, the summary of diabetes self-care activity questionnaire (SDSCA) will be used. The SDSCA questionnaire was developed by Deborah Toobert. It focuses on general diet, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. The instrument assesses the absolute frequency or consistency of ten diabetes health-related regimen behaviors (e.g., number of days per week on which respondents engage in physical activity sessions; number of days in past 7 days respondents ate five or more servings of fruits and vegetables). Reverse questions are scored in reverse, and the higher the total score, the better the diabetes self-care activity. The eleventh question asks whether there is smoking, and if so, it is counted as 1 point. The total SDSCA score ranges 1-71.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetes-related foot self-care behavior</measure>
      <time_frame>Baseline and after four and eight weeks</time_frame>
      <description>In this study, Chin &amp; Huang (2013) &quot;Diabetic Foot Self-Care Behavior Scale&quot; (DFSBS) will be used to measure diabetes-related foot self-care behavior at four weeks and eight weeks after baseline. The DFSBS has 7 questions, asking the participants how often they perform foot care behaviors. The total DFSBS score ranges 7-35. The higher the score, the better the foot care behavior. The DFSBS has sufficient reliability and validity (Chin &amp; Huang, 2013).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">178</enrollment>
    <condition>Diabetic Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object</description>
    </arm_group>
    <arm_group>
      <arm_group_label>comparison</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>customized standardized educational program sent by LINE software.</intervention_name>
      <description>At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object.</description>
      <arm_group_label>intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The inclusion criteria are:&#xD;
  &#xD;
            -  Outpatients with foot ulcers&#xD;
  &#xD;
            -  Diagnosed as diabetic patients&#xD;
  &#xD;
            -  Can be interviewed in Mandarin or Taiwanese.&#xD;
  &#xD;
          The exclusion criteria are:&#xD;
  &#xD;
            -  It is expected that there is no need to return to the clinic at the eighth week after&#xD;
               the baseline, or the number of return visits within eight weeks will be less than two&#xD;
               times&#xD;
  &#xD;
            -  Patient and family members living with him/her do not use a smart phone&#xD;
  &#xD;
            -  Being unable to read text messages on mobile phone, or with impaired hearing, could&#xD;
               not answer the phone&#xD;
  &#xD;
            -  Impaired fine hand movements, unable to click on mobile phone text messages&#xD;
  &#xD;
            -  Unwilling to use the communication software LINE to receive text messages.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
      <investigator_full_name>Chin yenfan</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>short message</keyword>
    <keyword>wound healing</keyword>
    <keyword>diabetic foot ulcer</keyword>
    <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>
    <!-- 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/NCT06037369
  org study id: NMRPD1N0241
  secondary id: NSTC112-2314-B-182-028
  nct id: NCT06037369
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to develop a short message-based customized standardized
        diabetic foot ulcer patient education program, and to test the effect of the program on
        diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of
        life. The short message-based customized standardized patient education program combines
        several smartphone message-based standardized educational contents to construct a customized
        patient education program which is according to the needs of patients, thus providing
        individualized patient education in a timely manner
  The purpose of this study is to develop a short message-based customized standardized
        diabetic foot ulcer patient education program, and to test the effect of the program on
        diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of
        life.
  
        The short message-based customized standardized patient education program combines several
        smartphone message-based standardized educational contents to construct a customized patient
        education program which is according to the needs of patients, thus providing individualized
        patient education in a timely manner. The short message-based customized standardized patient
        education program may improve the diabetic foot ulcers self-management behavior and the
        self-efficacy on diabetic foot ulcers self-management, thereby promoting wound healing and
        improving quality of life.
  
        In the first year, a customized standardized patient education program will be developed, and
        then the effectiveness evaluation will be carried out. A randomized controlled study design
        will be adopted, and 178 outpatients with diabetic foot ulcers are expected to be recruited.
        The control group will receive routine care, while the experimental group will receive a
        short message-based customized standardized diabetic foot ulcer patient education program
        after their outpatient visits. Subjects will be followed up for eight weeks, and the
        generalized estimating equation (GEE) will be used to evaluate the effectiveness of the
        intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants are assigned to two groups in parallel for the duration of the study
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Wound healing
  time frame: baseline and after four and eight weeks
  description: In this study, whether the percentage foot ulcer area reduction (PAR) reaches 50% after four weeks and whether DFU is healed is used as the evaluation index. We used the following formula to calculate the percentage area reduction (PAR): PAR = (primary wound area - secondary area / primary area) × 100
  measure: DFU Quality of life
  time frame: Baseline and after four and eight weeks
  description: Questionnaire on quality of life with chronic wounds (Wound QoL-17) will be used at four weeks and eight weeks after baseline to evaluate the change of QOL. Blome et al. (2014) Questionnaire on quality of life with chronic wound (Wound-QoL) has 17 items to measure the quality of life of patients with chronic wounds. Using the 5-point Likert scale, the patients were asked to report their chronic wounds in the past seven days, ranging from 0 (not at all) to 4 (very affected), with higher average scores indicating poorer quality of life. The total DFUSMB score ranges 0-68.
  measure: DFU self-management behavior
  time frame: Baseline and after four and eight weeks
  description: In this study, Chin et al. (2019) "DFU Self-Management Behavior Scale" (DFUSMB), will be used to measure DFU self-management behavior at four weeks and eight weeks after baseline.
  The DFUSMB measures behaviors that promote wound healing and prevent wound deterioration with 18 items in total, using the five-point Likert scale. "Never", "Seldom", "Sometimes", "Often" and "Always" are scored from 1 to 5 respectively. Reverse questions are scored in reverse, and the higher the total score, the better the self-management behavior of DFUs. The total DFUSMB score ranges 18-90.The DFUSMB has sufficient reliability and validity (Chin et al., 2019).
  measure: DFU self-management self-efficacy
  time frame: Baseline and after four and eight weeks
  description: The researcher developed the Diabetic Foot Ulcer Self-Efficacy Scale (DFUMSE) consisting of 17 self-constructed questions to measure self-efficacy in diabetic foot ulcer management. A scoring system of 0 to 10 points is used, where 0 points indicate no confidence at all, and 10 points indicate complete confidence. Higher scores indicate higher self-efficacy. The total DFUMSE score ranges 0-170.
  Two questions were used to measure self-efficacy for foot self-care:
  "I am confident that I can: Check the soles and toe gaps of my feet every day by myself (or with someone's assistance)." "I am confident that I can: Apply lotion or Vaseline to my feet every day by myself (or with someone's assistance) when the skin on my feet is dry." Both questions were scored using an 11-point scale, with 0 indicating no confidence at all and 10 indicating complete confidence. Higher scores reflect higher self-efficacy.
  measure: Diabetes self-care behaviors
  time frame: Baseline and after four and eight weeks
  description: The summary of diabetes self-care activity questionnaire (SDSCA) In this study, the summary of diabetes self-care activity questionnaire (SDSCA) will be used. The SDSCA questionnaire was developed by Deborah Toobert. It focuses on general diet, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. The instrument assesses the absolute frequency or consistency of ten diabetes health-related regimen behaviors (e.g., number of days per week on which respondents engage in physical activity sessions; number of days in past 7 days respondents ate five or more servings of fruits and vegetables). Reverse questions are scored in reverse, and the higher the total score, the better the diabetes self-care activity. The eleventh question asks whether there is smoking, and if so, it is counted as 1 point. The total SDSCA score ranges 1-71.
  measure: Diabetes-related foot self-care behavior
  time frame: Baseline and after four and eight weeks
  description: In this study, Chin & Huang (2013) "Diabetic Foot Self-Care Behavior Scale" (DFSBS) will be used to measure diabetes-related foot self-care behavior at four weeks and eight weeks after baseline. The DFSBS has 7 questions, asking the participants how often they perform foot care behaviors. The total DFSBS score ranges 7-35. The higher the score, the better the foot care behavior. The DFSBS has sufficient reliability and validity (Chin & Huang, 2013).
  arm group label: intervention
  arm group type: Experimental
  description: At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object
  arm group label: comparison
  arm group type: No Intervention
  description: Routine care
  intervention type: Behavioral
  intervention name: customized standardized educational program sent by LINE software.
  description: At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object.
  arm group label: intervention
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Chang Gung Memorial Hospital
  investigator full name: Chin yenfan
  investigator title: assistant professor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer