<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/NCT04459546</url>
  </required_header>
  <id_info>
    <org_study_id>60116787-020/4317</org_study_id>
    <nct_id>NCT04459546</nct_id>
  </id_info>
  <brief_title>Nurse-led COPD Self-management Intervention</brief_title>
  <official_title>The Effect of Rational Drug Use and Symptom Control Training on Self-efficacy, Emotional Status and Clinical Parameters in COPD (Chronic Obstructive Pulmonary Disease)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Introduction: Chronic Obstructive Pulmonary Disease (COPD) disease highest mortality and&#xD;
      morbidity of respiratory diseases that third cause of death in the world and Turkey.&#xD;
&#xD;
      Purpose: Purpose of study improve self-efficacy, anxiety/depression, symptom control and&#xD;
      exercise capacity, reduce use of health care of COPD patients.&#xD;
&#xD;
      Method: The study was conducted with a randomized controlled design. This study were included&#xD;
      41 COPD patients (İntervention=20, Control=21). Data collection tools were patient&#xD;
      description form, COPD Self-Efficacy Scale (CSES), COPD Assessment Test (CAT), Hospital&#xD;
      Anxiety Depression Scale (HAD), 6-Minute Walk Test (MWT) and tele-health form. Intervention&#xD;
      consists patient education, training booklet and 3 month follow-up. Control group patients&#xD;
      received only general care. The final test was performed three months later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The skills and the knowledge necessary in COPD management and interventions required to&#xD;
      develop this skill have conceptualized as self-management. The complex structure of COPD&#xD;
      self-management includes medication compliance, smoking cessation, maintaining and increasing&#xD;
      exercise capacity, regulating nutrition, healthy lifestyle changes, vaccination and symptom&#xD;
      management.&#xD;
&#xD;
      According to the GOLD (2017) report, copd self-management cannot be achieved only with&#xD;
      didactic teaching. Skill acquisition, behavior change and motivational interventions should&#xD;
      be applied with education. Among these interventions, action plans are among the tools&#xD;
      frequently used in preventing tele-health COPD attacks. Action plans can be used effectively&#xD;
      in COPD to prevent attacks, symptom management and reduce the risk of anxiety / depression.&#xD;
      One objectives of self-management is to reduce use of health care. Symptom management; It has&#xD;
      been stated that it is effective in reducing hospitalization and days of hospitalization&#xD;
      especially in patients with COPD diseases.&#xD;
&#xD;
      In studies involving self-management in COPD, self-management interventions increase&#xD;
      health-related quality of life, control symptom, reduce the risk of anxiety / depression,&#xD;
      increase self-efficacy, reduce respiratory hospital stays, reduce severity and duration of&#xD;
      attacks, and reduce mortality at low impact. It is stated that the interventions made in the&#xD;
      GOLD (2017) report provide improvements for health-related quality of life and patient&#xD;
      outcomes. Because of self-management is a multi-component concept, variety in type of&#xD;
      intervention and follow-up make it difficult to reach generalizable evidence.&#xD;
&#xD;
      Although many health professionals work with patients with COPD, self-management&#xD;
      interventions are known to be carried out mostly by nurses or by multidisciplinary groups&#xD;
      involving nurses.&#xD;
&#xD;
      This study is an example of applicable self-management intervention in terms of disease&#xD;
      information and general management, rational drug use, symptom control training and&#xD;
      evaluation with medium-term monitoring. It can contribute to literature in terms of&#xD;
      determining the effect of nurse-managed self-management intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2018</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">February 17, 2019</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>Randomized controlled pre-post test design</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COPD Self-Efficacy Score</measure>
    <time_frame>Change from baseline COPD self-efficacy score at 3 months</time_frame>
    <description>Scales were filled in by interviewing each participant.Scoring is done between 1-5 points. Increased score indicates an increase in self-efficacy in coping with respiratory distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COPD Assessment Test Score</measure>
    <time_frame>Change from baseline COPD assessment test score at 3 months</time_frame>
    <description>Scales were filled in by interviewing each participant.Scoring is done between 0-40 points. Increased points indicate that the severity of the disease decreases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Depression Score</measure>
    <time_frame>Change from baseline anxiety depression test score at 3 months</time_frame>
    <description>Scales were filled in by interviewing each participant. Turkey cut-off score of the scale used for anxiety, 10, were found to be 7 for depression. Participants who scored above these points were evaluated as risky.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6-Minute Walk Test</measure>
    <time_frame>Change from baseline 6-minute walk distance at 3 months</time_frame>
    <description>Each participant received a 6-minute walk test as recommended by the AmericanThoracic Society.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of health care uses</measure>
    <time_frame>Change in the number of initial health care use in the 3rd month</time_frame>
    <description>According to the patient's declaration, emergency room visit, chest diseases outpatient clinic and hospitalizations associated with respiration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>COPD</condition>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study group intervention consists patient education, training booklet and 3 month follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group received only general care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>patient education, training booklet, 3 months tele health</intervention_name>
    <description>Patient education includes general disease information, COPD self-management and symptom control. The education face-to-face and practical training was provided by the researcher. The training booklet was prepared by the researcher. The readability of the booklet was very easy and its comprehensibility was tested by pre-application. Tele monitoring was done by the researcher for support and motivation. The participants were called 4 times by phone.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a diagnosis of COPD&#xD;
&#xD;
          -  Being inpatient at chest diseases clinic&#xD;
&#xD;
          -  Being literate&#xD;
&#xD;
          -  Able to use a telephone&#xD;
&#xD;
          -  No communication disabilities&#xD;
&#xD;
          -  Being volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having mental illness&#xD;
&#xD;
          -  Respiratory comorbidity (lung cancer, interstitial lung disease, pulmonary&#xD;
             tuberculosis),&#xD;
&#xD;
          -  Unable to attend the post-tests&#xD;
&#xD;
          -  Not reachable by phone&#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_official>
    <last_name>Nevin K Kurban, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Consultant, Responsible researcher</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Şenay Takmak, pHd</last_name>
    <role>Principal Investigator</role>
    <affiliation>pHd student, Assistant researcher</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denizli Public Hospitals Association, Buldan Chest Diseases Hospital</name>
      <address>
        <city>Denizli</city>
        <zip>20000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kasikci MK. Using self-efficacy theory to educate a patient with chronic obstructive pulmonary disease: A case study of 1-year follow-up. Int J Nurs Pract. 2011 Feb;17(1):1-8. doi: 10.1111/j.1440-172X.2010.01898.x.</citation>
    <PMID>21251148</PMID>
  </reference>
  <reference>
    <citation>Global Initiative for Chronic Obstructive Lung Disease, From the Global Strategy for the Diagnosis, Management and Prevention of COPD, GOLD 2017, p.139. https://goldcopd.org/wp-content/uploads/2017/02/wms-GOLD-2017-FINAL.pdf (access date: 10.08.2018)</citation>
  </reference>
  <reference>
    <citation>Harrison SL, Janaudis-Ferreira T, Brooks D, Desveaux L, Goldstein RS. Self-management following an acute exacerbation of COPD: a systematic review. Chest. 2015 Mar;147(3):646-661. doi: 10.1378/chest.14-1658.</citation>
    <PMID>25340578</PMID>
  </reference>
  <results_reference>
    <citation>Trappenburg JC, Koevoets L, de Weert-van Oene GH, Monninkhof EM, Bourbeau J, Troosters T, Verheij TJ, Lammers JW, Schrijvers AJ. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulm Med. 2009 Dec 29;9:52. doi: 10.1186/1471-2466-9-52.</citation>
    <PMID>20040088</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 30, 2022</last_update_submitted>
  <last_update_submitted_qc>January 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Şenay Takmak</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>nursing</keyword>
  <keyword>self-efficacy</keyword>
  <keyword>self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study results will be announced in a publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Findings can be shared after the study has been published.</ipd_time_frame>
    <ipd_access_criteria>The sociodemographic and disease-related characteristics of the participants, the pre-post-test findings including the answers to the research questions and statistical analyzes will be shared.</ipd_access_criteria>
    <ipd_url>http://acikerisim.pau.edu.tr/xmlui/handle/11499/28554</ipd_url>
  </patient_data>
  <!-- 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/NCT04459546
org study id: 60116787-020/4317
nct id: NCT04459546
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: Chronic Obstructive Pulmonary Disease (COPD) disease highest mortality and
      morbidity of respiratory diseases that third cause of death in the world and Turkey.

      Purpose: Purpose of study improve self-efficacy, anxiety/depression, symptom control and
      exercise capacity, reduce use of health care of COPD patients.

      Method: The study was conducted with a randomized controlled design. This study were included
      41 COPD patients (İntervention=20, Control=21). Data collection tools were patient
      description form, COPD Self-Efficacy Scale (CSES), COPD Assessment Test (CAT), Hospital
      Anxiety Depression Scale (HAD), 6-Minute Walk Test (MWT) and tele-health form. Intervention
      consists patient education, training booklet and 3 month follow-up. Control group patients
      received only general care. The final test was performed three months later.
The skills and the knowledge necessary in COPD management and interventions required to
      develop this skill have conceptualized as self-management. The complex structure of COPD
      self-management includes medication compliance, smoking cessation, maintaining and increasing
      exercise capacity, regulating nutrition, healthy lifestyle changes, vaccination and symptom
      management.

      According to the GOLD (2017) report, copd self-management cannot be achieved only with
      didactic teaching. Skill acquisition, behavior change and motivational interventions should
      be applied with education. Among these interventions, action plans are among the tools
      frequently used in preventing tele-health COPD attacks. Action plans can be used effectively
      in COPD to prevent attacks, symptom management and reduce the risk of anxiety / depression.
      One objectives of self-management is to reduce use of health care. Symptom management; It has
      been stated that it is effective in reducing hospitalization and days of hospitalization
      especially in patients with COPD diseases.

      In studies involving self-management in COPD, self-management interventions increase
      health-related quality of life, control symptom, reduce the risk of anxiety / depression,
      increase self-efficacy, reduce respiratory hospital stays, reduce severity and duration of
      attacks, and reduce mortality at low impact. It is stated that the interventions made in the
      GOLD (2017) report provide improvements for health-related quality of life and patient
      outcomes. Because of self-management is a multi-component concept, variety in type of
      intervention and follow-up make it difficult to reach generalizable evidence.

      Although many health professionals work with patients with COPD, self-management
      interventions are known to be carried out mostly by nurses or by multidisciplinary groups
      involving nurses.

      This study is an example of applicable self-management intervention in terms of disease
      information and general management, rational drug use, symptom control training and
      evaluation with medium-term monitoring. It can contribute to literature in terms of
      determining the effect of nurse-managed self-management intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled pre-post test design
primary purpose: Supportive Care
masking: None (Open Label)
measure: COPD Self-Efficacy Score
time frame: Change from baseline COPD self-efficacy score at 3 months
description: Scales were filled in by interviewing each participant.Scoring is done between 1-5 points. Increased score indicates an increase in self-efficacy in coping with respiratory distress.
measure: COPD Assessment Test Score
time frame: Change from baseline COPD assessment test score at 3 months
description: Scales were filled in by interviewing each participant.Scoring is done between 0-40 points. Increased points indicate that the severity of the disease decreases.
measure: Anxiety Depression Score
time frame: Change from baseline anxiety depression test score at 3 months
description: Scales were filled in by interviewing each participant. Turkey cut-off score of the scale used for anxiety, 10, were found to be 7 for depression. Participants who scored above these points were evaluated as risky.
measure: 6-Minute Walk Test
time frame: Change from baseline 6-minute walk distance at 3 months
description: Each participant received a 6-minute walk test as recommended by the AmericanThoracic Society.
measure: Number of health care uses
time frame: Change in the number of initial health care use in the 3rd month
description: According to the patient's declaration, emergency room visit, chest diseases outpatient clinic and hospitalizations associated with respiration
arm group label: Study group
arm group type: Experimental
description: Study group intervention consists patient education, training booklet and 3 month follow-up.
arm group label: Control group
arm group type: No Intervention
description: Control group received only general care
intervention type: Behavioral
intervention name: patient education, training booklet, 3 months tele health
description: Patient education includes general disease information, COPD self-management and symptom control. The education face-to-face and practical training was provided by the researcher. The training booklet was prepared by the researcher. The readability of the booklet was very easy and its comprehensibility was tested by pre-application. Tele monitoring was done by the researcher for support and motivation. The participants were called 4 times by phone.
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nevin K Kurban, Prof. Dr.
role: Study Director
affiliation: Consultant, Responsible researcher
last name: Şenay Takmak, pHd
role: Principal Investigator
affiliation: pHd student, Assistant researcher
facility: 
country: Turkey
citation: Kasikci MK. Using self-efficacy theory to educate a patient with chronic obstructive pulmonary disease: A case study of 1-year follow-up. Int J Nurs Pract. 2011 Feb;17(1):1-8. doi: 10.1111/j.1440-172X.2010.01898.x.
PMID: 21251148
citation: Global Initiative for Chronic Obstructive Lung Disease, From the Global Strategy for the Diagnosis, Management and Prevention of COPD, GOLD 2017, p.139. https://goldcopd.org/wp-content/uploads/2017/02/wms-GOLD-2017-FINAL.pdf (access date: 10.08.2018)
citation: Harrison SL, Janaudis-Ferreira T, Brooks D, Desveaux L, Goldstein RS. Self-management following an acute exacerbation of COPD: a systematic review. Chest. 2015 Mar;147(3):646-661. doi: 10.1378/chest.14-1658.
PMID: 25340578
citation: Trappenburg JC, Koevoets L, de Weert-van Oene GH, Monninkhof EM, Bourbeau J, Troosters T, Verheij TJ, Lammers JW, Schrijvers AJ. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulm Med. 2009 Dec 29;9:52. doi: 10.1186/1471-2466-9-52.
PMID: 20040088
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Şenay Takmak
investigator title: PhD student
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Yes
ipd description: Study results will be announced in a publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Findings can be shared after the study has been published.
ipd access criteria: The sociodemographic and disease-related characteristics of the participants, the pre-post-test findings including the answers to the research questions and statistical analyzes will be shared.
ipd url: http://acikerisim.pau.edu.tr/xmlui/handle/11499/28554