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/NCT06032429</url>
    </required_header>
    <id_info>
      <org_study_id>B10703021</org_study_id>
      <nct_id>NCT06032429</nct_id>
    </id_info>
    <brief_title>Effects of Shared Medical Appointments for Diabetic Patients in Taiwan</brief_title>
    <official_title>Effects of the Shared Medical Appointments on Blood Glucose and Self-care Efficacy for Middle-aged Patients With Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dalin Tzu Chi General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dalin Tzu Chi General 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>
        This quasi-experimental study is done to investigate the effect of Shared Medical&#xD;
        Appointments (SMA) program for the diabetic patients in Taiwan. The relevant corresponding&#xD;
        effects were determined via the generalized estimating equation (GEE) model.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design and participants A quasi-experimental pre-posttest control group design, with&#xD;
        purposive sampling, was used to recruit participants from the Endocrinology department of a&#xD;
        hospital in southern Taiwan from Jan to Dec in 2019. The inclusion criteria were (i) being at&#xD;
        least 20 years old at the time of recruitment (ii) having no cognitive impairment and severe&#xD;
        complications, (iii) being able to express opinions in either Mandarin or Taiwanese, and (iv)&#xD;
        having a diagnosis of diabetes. To ensure participants' anonymity, all questionnaires were&#xD;
        marked with an encryption code to facilitate data analysis, but with no personal identifiers.&#xD;
  &#xD;
        Sample size calculation Sample size calculation for this analysis of repeated measures to&#xD;
        detect an effect size of 0.4 at 80% power and a 0.05 significance level indicated that a&#xD;
        sample size of 56 patients is needed (according to G- POWER 3.1 analytical software, Franz&#xD;
        Faul, Universitat Kiel, Germany). A sample of at least 68 participants for both groups&#xD;
        combined was required on the basis of these parameters, allowing for a 20% attrition rate.&#xD;
  &#xD;
        Intervention Because continued participation was essential for this study, the participants&#xD;
        were divided into the experiment or control group in accordance with the personal&#xD;
        willingness. The control group received routine health education lasting for about 30 minutes&#xD;
        per medical visit, which consisted of consultation about disease symptoms, related&#xD;
        treatments, and self-care skills. They would receive health education instruction leaflets&#xD;
        for reference purposes if necessary.&#xD;
  &#xD;
        The experiment group received four shared medical appointments (SMP) -based group education&#xD;
        sessions (7-10 participants, 1.5 hours each) for four consecutive weeks in addition to&#xD;
        routine health education at a private room in the outpatient unit. One registered nurse who&#xD;
        received SMP facilitator training, from the Taiwanese Association of Diabetic Educators,&#xD;
        served as the class facilitator. SMP sessions were conducted using several colored maps&#xD;
        covering different topics, which included &quot;healthy diet and exercises&quot;, &quot;relevant treatment&#xD;
        towards diabetic medications&quot;, &quot; self-monitoring of blood glucose,&quot; and &quot;treatment on&#xD;
        hypoglycemia and hyperglycemia&quot; . This procedure served to create mutual imagery to be shared&#xD;
        with participants. In addition to using these colored maps, the facilitator further offered&#xD;
        participants self-designed conversation cards and asked them to share individual glycemic&#xD;
        control experiences based on the questions shown on the cards.&#xD;
  &#xD;
        Outcome measures The primary outcomes were composed of two self-development tools, namely&#xD;
        diabetic self-management questionnaire (DSMQ) as well as diabetic self-care questionnaire&#xD;
        (DSCQ).&#xD;
  &#xD;
        On the other hand, the consideration of covariates contained additional items addressing&#xD;
        demographic and disease characteristics were developed based on clinical experience and&#xD;
        literature review, and were collected at study entry via patient interviews and medical&#xD;
        records. Demographic data included sex, age, marital status, education level, religion,&#xD;
        household status, monthly income, and certain lifestyle factors, such as smoking, exercise&#xD;
        habits, and presence of sleep disturbances. Smoking status was recorded as &quot;non-smoker&quot; or&#xD;
        &quot;current or ex-smoker.&quot; Those who exercised regularly (i.e., weekly) were classified as&#xD;
        having &quot;exercise habits.&quot; Sleep disturbances were defined as waking up at night more than&#xD;
        twice without external factors during the week before the interview. Disease characteristics&#xD;
        included the presence of chronic disease (i.e., stroke, hypertension, heart disease, renal&#xD;
        disease, or cancer), medication regimen, and duration of diabetes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2019</start_date>
    <completion_date type="Actual">December 31, 2020</completion_date>
    <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the self-management level assessed by the self-developed scale</measure>
      <time_frame>up to six months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>the self-care level assessed by the self-developed scale</measure>
      <time_frame>up to six months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">70</enrollment>
    <condition>Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Shared Medical Appointments</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This strategy is conducted by groups of patients meeting over time for comprehensive care, usually involving a practitioner with prescribing privileges, for a defining chronic condition or health care state. Meanwhile, this model often use educational and/or self-management enhancement strategies, paired with medication management, in an effort to achieve improved disease outcomes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine health education without more advanced illustration</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Shared Medical Appointments</intervention_name>
      <description>SMA is a subset of such clinics and are defined by groups of patients meeting over time for comprehensive care for a defining chronic condition or health care state, which involved both a person trained or skilled in delivering patient education or facilitating patient interaction.</description>
      <arm_group_label>Shared Medical Appointments</arm_group_label>
      <other_name>Standard care</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being at least 20 years old at the time of recruitment,&#xD;
  &#xD;
            -  having no cognitive impairment and severe complications,&#xD;
  &#xD;
            -  being able to express opinions in either Mandarin or Taiwanese, and&#xD;
  &#xD;
            -  having a diagnosis of DM.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  being unwillingness to participant this work&#xD;
  &#xD;
            -  Attending the similar health education program in the past&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pin-Fan Chen</last_name>
      <role>Study Director</role>
      <affiliation>Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pin-Fan Chen</name>
        <address>
          <city>Chiayi City</city>
          <state>Chiayi</state>
          <zip>62247</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 23, 2021</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Diabete Mellitus</keyword>
    <keyword>Taiwan</keyword>
    <keyword>effect</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06032429
  org study id: B10703021
  nct id: NCT06032429
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This quasi-experimental study is done to investigate the effect of Shared Medical
        Appointments (SMA) program for the diabetic patients in Taiwan. The relevant corresponding
        effects were determined via the generalized estimating equation (GEE) model.
  Study design and participants A quasi-experimental pre-posttest control group design, with
        purposive sampling, was used to recruit participants from the Endocrinology department of a
        hospital in southern Taiwan from Jan to Dec in 2019. The inclusion criteria were (i) being at
        least 20 years old at the time of recruitment (ii) having no cognitive impairment and severe
        complications, (iii) being able to express opinions in either Mandarin or Taiwanese, and (iv)
        having a diagnosis of diabetes. To ensure participants' anonymity, all questionnaires were
        marked with an encryption code to facilitate data analysis, but with no personal identifiers.
  
        Sample size calculation Sample size calculation for this analysis of repeated measures to
        detect an effect size of 0.4 at 80% power and a 0.05 significance level indicated that a
        sample size of 56 patients is needed (according to G- POWER 3.1 analytical software, Franz
        Faul, Universitat Kiel, Germany). A sample of at least 68 participants for both groups
        combined was required on the basis of these parameters, allowing for a 20% attrition rate.
  
        Intervention Because continued participation was essential for this study, the participants
        were divided into the experiment or control group in accordance with the personal
        willingness. The control group received routine health education lasting for about 30 minutes
        per medical visit, which consisted of consultation about disease symptoms, related
        treatments, and self-care skills. They would receive health education instruction leaflets
        for reference purposes if necessary.
  
        The experiment group received four shared medical appointments (SMP) -based group education
        sessions (7-10 participants, 1.5 hours each) for four consecutive weeks in addition to
        routine health education at a private room in the outpatient unit. One registered nurse who
        received SMP facilitator training, from the Taiwanese Association of Diabetic Educators,
        served as the class facilitator. SMP sessions were conducted using several colored maps
        covering different topics, which included "healthy diet and exercises", "relevant treatment
        towards diabetic medications", " self-monitoring of blood glucose," and "treatment on
        hypoglycemia and hyperglycemia" . This procedure served to create mutual imagery to be shared
        with participants. In addition to using these colored maps, the facilitator further offered
        participants self-designed conversation cards and asked them to share individual glycemic
        control experiences based on the questions shown on the cards.
  
        Outcome measures The primary outcomes were composed of two self-development tools, namely
        diabetic self-management questionnaire (DSMQ) as well as diabetic self-care questionnaire
        (DSCQ).
  
        On the other hand, the consideration of covariates contained additional items addressing
        demographic and disease characteristics were developed based on clinical experience and
        literature review, and were collected at study entry via patient interviews and medical
        records. Demographic data included sex, age, marital status, education level, religion,
        household status, monthly income, and certain lifestyle factors, such as smoking, exercise
        habits, and presence of sleep disturbances. Smoking status was recorded as "non-smoker" or
        "current or ex-smoker." Those who exercised regularly (i.e., weekly) were classified as
        having "exercise habits." Sleep disturbances were defined as waking up at night more than
        twice without external factors during the week before the interview. Disease characteristics
        included the presence of chronic disease (i.e., stroke, hypertension, heart disease, renal
        disease, or cancer), medication regimen, and duration of diabetes.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: the self-management level assessed by the self-developed scale
  time frame: up to six months
  measure: the self-care level assessed by the self-developed scale
  time frame: up to six months
  arm group label: Shared Medical Appointments
  arm group type: Experimental
  description: This strategy is conducted by groups of patients meeting over time for comprehensive care, usually involving a practitioner with prescribing privileges, for a defining chronic condition or health care state. Meanwhile, this model often use educational and/or self-management enhancement strategies, paired with medication management, in an effort to achieve improved disease outcomes.
  arm group label: Standard care
  arm group type: No Intervention
  description: Routine health education without more advanced illustration
  intervention type: Other
  intervention name: Shared Medical Appointments
  description: SMA is a subset of such clinics and are defined by groups of patients meeting over time for comprehensive care for a defining chronic condition or health care state, which involved both a person trained or skilled in delivering patient education or facilitating patient interaction.
  arm group label: Shared Medical Appointments
  other name: Standard care
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Pin-Fan Chen
  role: Study Director
  affiliation: Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  sharing ipd: Undecided