<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/NCT04462887</url>
  </required_header>
  <id_info>
    <org_study_id>13730</org_study_id>
    <secondary_id>R01NR004766</secondary_id>
    <nct_id>NCT04462887</nct_id>
  </id_info>
  <brief_title>Nursing Interventions Following Sudden Cardiac Arrest</brief_title>
  <official_title>Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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>
      Determine the benefits of implantable cardioverter defibrillator (ICD) patients participating&#xD;
      in a structured, 8-week educational telephone intervention delivered by expert cardiovascular&#xD;
      nurses post-ICD. To determine if individuals participating in a post-hospital telephone&#xD;
      nursing intervention would demonstrate (1) increased physical functioning, (2) increased&#xD;
      psychological adjustment, (3) improved self-efficacy in managing the challenges of ICD&#xD;
      recovery, and (4) lower levels of health care utilization over usual care at 1, 3, 6 and 12&#xD;
      months post-ICD implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the study was to determine if a short-term social cognitive theory intervention&#xD;
      would improve physical functioning and enhance psychological adjustment after receiving a&#xD;
      first time ICD. The central aim of this study was to determine if individuals participating&#xD;
      in a telephone nursing intervention compared to usual care demonstrated (1) improved physical&#xD;
      functioning, (2) improved psychological adjustment, 3) improved knowledge related to sudden&#xD;
      cardiac arrest (SCA) and the ICD, and (4) lower levels of health care use over a 3-month&#xD;
      period post-ICD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1998</start_date>
  <completion_date type="Actual">December 31, 2003</completion_date>
  <primary_completion_date type="Actual">December 31, 2003</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Concerns Assessment (PCA)</measure>
    <time_frame>Change in patient concerns from baseline to 12 months</time_frame>
    <description>scores from 0 to 58 in which lower scores reflect fewer symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-12 Short Form Health Survey (SF-12)</measure>
    <time_frame>change in general health (SF-12) score from baseline to 12 months</time_frame>
    <description>scores from 0 to 100 with higher scores representing better self-reported health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>change in anxiety (STAI) score from baseline to 12 months</time_frame>
    <description>Scores range from 20 to 80. Higher scores indicating greater anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of ICD shocks</measure>
    <time_frame>change in number of ICD shocks from baseline to 12 months</time_frame>
    <description>The number of ICD shocks (if any) that the patient received from the ICD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>change in depression (CES-D) score from baseline to 12 months</time_frame>
    <description>Scores range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)</measure>
    <time_frame>change in efficacy expectations from baseline to 12 months</time_frame>
    <description>SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The first 8 items measure self-efficacy. Score for this sub-scale ranges from 0 to 8. higher the score greater is the self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias</measure>
    <time_frame>change in number of ER visits from baseline to 12 months</time_frame>
    <description>The number of times a person went to the ER for evaluation over 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinic visits related to the ICD</measure>
    <time_frame>change in number of clinic visits from baseline to 12 months</time_frame>
    <description>The number of times a person had an outpatient clinic visit for the ICD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions for ICD or cardiac related</measure>
    <time_frame>change in number of hospital admission from baseline to 12 months</time_frame>
    <description>The number of times a person stayed overnight, at least 24 hours, in the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sudden Cardiac Arrest (SCA) Knowledge</measure>
    <time_frame>change in SCA knowledge from baseline to 12 months</time_frame>
    <description>Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rhythm stability</measure>
    <time_frame>change in heart rhythm stability from baseline to 12 months</time_frame>
    <description>self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)</measure>
    <time_frame>change in self-management behavior from baseline to 12 months</time_frame>
    <description>SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The items - to 16 measure self-management behavior. Score range from 0 to 8 for self-management behavior skills. Higher the score greater is the self-management behavior skills.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>ICD</condition>
  <arm_group>
    <arm_group_label>Nursing intervention program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The nursing intervention program consisting of 3 parts: (1) Structural Informational (SI) booklet, (2) Nursing Telephone Support (NTS) protocol, and (3) Nurse Pager 24/7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care participants received treatment as usual from their health care providers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nursing intervention program</intervention_name>
    <description>The intervention consisted of structured information (SI) provided in a booklet, nursing telephone support (NTS) and access to a nurse pager 24h/day. The SI booklet, Sudden Cardiac Arrest: A Survivor's Experience, contains 2 components: a descriptive component including individual verbatim statements about experiences of others during the first year of recovery and a management component outlining successful strategies used by others in dealing with issues in recovery. The NTS telephone calls included: check-in about current concerns, assessment of the topic for the week, review of common recovery experiences, discussion of behavioral strategies for dealing with the topic for the week, provision of positive feedback for strategies already working well, anxiety reduction statements, practice of new behaviors using role-playing and problem solving techniques, summarization, setting specific goals for the upcoming week, and collaborating on a learning assignment for the subsequent week.</description>
    <arm_group_label>Nursing intervention program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the ability to read, speak, and write English,&#xD;
&#xD;
          -  having telephone access,&#xD;
&#xD;
          -  willingness to be followed for 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant clinical comorbidities that prevented their return home after&#xD;
             hospitalization,&#xD;
&#xD;
          -  younger than 21 years of age,&#xD;
&#xD;
          -  Short BLESSED cognitive screening tool scores ≥10.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia M. Dougherty, PhD, ARNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <reference>
    <citation>Dougherty CM, Johnson-Crowley NR, Lewis FM, Thompson EA. Theoretical development of nursing interventions for sudden cardiac arrest survivors using social cognitive theory. ANS Adv Nurs Sci. 2001 Sep;24(1):78-86. doi: 10.1097/00012272-200109000-00009.</citation>
    <PMID>11554535</PMID>
  </reference>
  <results_reference>
    <citation>Dougherty CM, Thompson EA, Lewis FM. Long-term outcomes of a telephone intervention after an ICD. Pacing Clin Electrophysiol. 2005 Nov;28(11):1157-67. doi: 10.1111/j.1540-8159.2005.09500.x.</citation>
    <PMID>16359281</PMID>
  </results_reference>
  <results_reference>
    <citation>Dougherty CM, Lewis FM, Thompson EA, Baer JD, Kim W. Short-term efficacy of a telephone intervention by expert nurses after an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2004 Dec;27(12):1594-602. doi: 10.1111/j.1540-8159.2004.00691.x.</citation>
    <PMID>15613121</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Cynthia M. Dougherty</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04462887
org study id: 13730
secondary id: R01NR004766
nct id: NCT04462887
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determine the benefits of implantable cardioverter defibrillator (ICD) patients participating
      in a structured, 8-week educational telephone intervention delivered by expert cardiovascular
      nurses post-ICD. To determine if individuals participating in a post-hospital telephone
      nursing intervention would demonstrate (1) increased physical functioning, (2) increased
      psychological adjustment, (3) improved self-efficacy in managing the challenges of ICD
      recovery, and (4) lower levels of health care utilization over usual care at 1, 3, 6 and 12
      months post-ICD implantation.
The goal of the study was to determine if a short-term social cognitive theory intervention
      would improve physical functioning and enhance psychological adjustment after receiving a
      first time ICD. The central aim of this study was to determine if individuals participating
      in a telephone nursing intervention compared to usual care demonstrated (1) improved physical
      functioning, (2) improved psychological adjustment, 3) improved knowledge related to sudden
      cardiac arrest (SCA) and the ICD, and (4) lower levels of health care use over a 3-month
      period post-ICD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient Concerns Assessment (PCA)
time frame: Change in patient concerns from baseline to 12 months
description: scores from 0 to 58 in which lower scores reflect fewer symptoms
measure: SF-12 Short Form Health Survey (SF-12)
time frame: change in general health (SF-12) score from baseline to 12 months
description: scores from 0 to 100 with higher scores representing better self-reported health
measure: State-Trait Anxiety Inventory (STAI)
time frame: change in anxiety (STAI) score from baseline to 12 months
description: Scores range from 20 to 80. Higher scores indicating greater anxiety.
measure: Number of ICD shocks
time frame: change in number of ICD shocks from baseline to 12 months
description: The number of ICD shocks (if any) that the patient received from the ICD
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: change in depression (CES-D) score from baseline to 12 months
description: Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
time frame: change in efficacy expectations from baseline to 12 months
description: SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The first 8 items measure self-efficacy. Score for this sub-scale ranges from 0 to 8. higher the score greater is the self-efficacy.
measure: Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias
time frame: change in number of ER visits from baseline to 12 months
description: The number of times a person went to the ER for evaluation over 12 months
measure: Number of clinic visits related to the ICD
time frame: change in number of clinic visits from baseline to 12 months
description: The number of times a person had an outpatient clinic visit for the ICD
measure: Number of hospital admissions for ICD or cardiac related
time frame: change in number of hospital admission from baseline to 12 months
description: The number of times a person stayed overnight, at least 24 hours, in the hospital.
measure: Sudden Cardiac Arrest (SCA) Knowledge
time frame: change in SCA knowledge from baseline to 12 months
description: Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.
measure: Heart rhythm stability
time frame: change in heart rhythm stability from baseline to 12 months
description: self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits
measure: Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
time frame: change in self-management behavior from baseline to 12 months
description: SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The items - to 16 measure self-management behavior. Score range from 0 to 8 for self-management behavior skills. Higher the score greater is the self-management behavior skills.
arm group label: Nursing intervention program
arm group type: Experimental
description: The nursing intervention program consisting of 3 parts: (1) Structural Informational (SI) booklet, (2) Nursing Telephone Support (NTS) protocol, and (3) Nurse Pager 24/7.
arm group label: Usual Care Group
arm group type: No Intervention
description: Usual care participants received treatment as usual from their health care providers.
intervention type: Behavioral
intervention name: Nursing intervention program
description: The intervention consisted of structured information (SI) provided in a booklet, nursing telephone support (NTS) and access to a nurse pager 24h/day. The SI booklet, Sudden Cardiac Arrest: A Survivor's Experience, contains 2 components: a descriptive component including individual verbatim statements about experiences of others during the first year of recovery and a management component outlining successful strategies used by others in dealing with issues in recovery. The NTS telephone calls included: check-in about current concerns, assessment of the topic for the week, review of common recovery experiences, discussion of behavioral strategies for dealing with the topic for the week, provision of positive feedback for strategies already working well, anxiety reduction statements, practice of new behaviors using role-playing and problem solving techniques, summarization, setting specific goals for the upcoming week, and collaborating on a learning assignment for the subsequent week.
arm group label: Nursing intervention program
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Cynthia M. Dougherty, PhD, ARNP
role: Principal Investigator
affiliation: University of Washington
citation: Dougherty CM, Johnson-Crowley NR, Lewis FM, Thompson EA. Theoretical development of nursing interventions for sudden cardiac arrest survivors using social cognitive theory. ANS Adv Nurs Sci. 2001 Sep;24(1):78-86. doi: 10.1097/00012272-200109000-00009.
PMID: 11554535
citation: Dougherty CM, Thompson EA, Lewis FM. Long-term outcomes of a telephone intervention after an ICD. Pacing Clin Electrophysiol. 2005 Nov;28(11):1157-67. doi: 10.1111/j.1540-8159.2005.09500.x.
PMID: 16359281
citation: Dougherty CM, Lewis FM, Thompson EA, Baer JD, Kim W. Short-term efficacy of a telephone intervention by expert nurses after an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2004 Dec;27(12):1594-602. doi: 10.1111/j.1540-8159.2004.00691.x.
PMID: 15613121
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Cynthia M. Dougherty
investigator title: Professor
mesh term: Heart Arrest
mesh term: Death, Sudden, Cardiac
sharing ipd: No