<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/NCT02978794</url>
  </required_header>
  <id_info>
    <org_study_id>CCH-161006</org_study_id>
    <nct_id>NCT02978794</nct_id>
  </id_info>
  <brief_title>Implementation of Clinical Pathway to Improve Quality of Healthcare in Stroke Inpatients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the extension of the average life expectancy, the incidence of cardiovascular diseases&#xD;
      is also rising. Stroke in Taiwan has been the leading cause of morbidity and mortality, but&#xD;
      also in countries around the world), stroke and the impact of socio-economic and health&#xD;
      spending are large how to reduce the degree of disability after stroke is an important issue&#xD;
      in medicine. For a long time, the resident will fill the clinical pathway form before the&#xD;
      stroke inpatients were discharged. We also analyzed the data of clinical pathway every three&#xD;
      months.&#xD;
&#xD;
      According to the current data of stroke clinical pathway included demographic data, length of&#xD;
      hospitalization days, complications, functional independent measure, Brunnstrom motor&#xD;
      recovery stage, mini-mental state examination, geriatric depression scale, blood pressure&#xD;
      data, and post-stroke checklist for a retrospective analysis to provide more complete and&#xD;
      more comprehensive information on follow-up care for stroke patients and effective use of&#xD;
      medical resources, to improve the quality of future medical care and quality of life for&#xD;
      stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>functional independent measurement</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>post-stroke checklist</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Brunnstrom motor recovery stage</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        stroke inpatient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ischemic and hemorrhagic stroke patients&#xD;
&#xD;
          2. MRI confirmed the diagnosis of stroke&#xD;
&#xD;
          3. Within three months of onset of unilateral limb hemiplegia in patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Initial tracheostomy impantation and hospital stay is less than 5 days&#xD;
&#xD;
          2. Combined with other neurological diseases, such as epilepsy, multiple neuropathy,&#xD;
             Meniere's disease, vestibular neuritis, Parkinson's disease, dementia or cerebellar&#xD;
             atrophy, etc.&#xD;
&#xD;
          3. Significant lesions of the lower limb joints, including joint contractures, lower limb&#xD;
             fractures, joint replacement or long-term pain in patients with osteoarthritis&#xD;
&#xD;
          4. Unstable signs of life (if not through the tilt bed test) or severe cardiopulmonary&#xD;
             disease&#xD;
&#xD;
          5. Those who can not cooperate with the study or who have not signed the inform consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
    <investigator_full_name>Ta-Sen Wei,MD</investigator_full_name>
    <investigator_title>Director, Physical Medical and Rehabilitation, Principal Investigator,</investigator_title>
  </responsible_party>
  <keyword>stroke, clinical pathway, medical care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02978794
org study id: CCH-161006
nct id: NCT02978794
lead sponsor: 
has dmc: Yes
With the extension of the average life expectancy, the incidence of cardiovascular diseases
      is also rising. Stroke in Taiwan has been the leading cause of morbidity and mortality, but
      also in countries around the world), stroke and the impact of socio-economic and health
      spending are large how to reduce the degree of disability after stroke is an important issue
      in medicine. For a long time, the resident will fill the clinical pathway form before the
      stroke inpatients were discharged. We also analyzed the data of clinical pathway every three
      months.

      According to the current data of stroke clinical pathway included demographic data, length of
      hospitalization days, complications, functional independent measure, Brunnstrom motor
      recovery stage, mini-mental state examination, geriatric depression scale, blood pressure
      data, and post-stroke checklist for a retrospective analysis to provide more complete and
      more comprehensive information on follow-up care for stroke patients and effective use of
      medical resources, to improve the quality of future medical care and quality of life for
      stroke patients.
observational model: Cohort
time perspective: Prospective
measure: functional independent measurement
time frame: 1 year
measure: post-stroke checklist
time frame: 1 year
measure: Brunnstrom motor recovery stage
time frame: 1 year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Changhua Christian Hospital
investigator full name: Ta-Sen Wei,MD
investigator title: Director, Physical Medical and Rehabilitation, Principal Investigator,
mesh term: Stroke