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Nursing Interventions Following Sudden Cardiac Arrest

Primary Purpose

ICD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nursing intervention program
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ICD

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the ability to read, speak, and write English,
  • having telephone access,
  • willingness to be followed for 1 year.

Exclusion Criteria:

  • significant clinical comorbidities that prevented their return home after hospitalization,
  • younger than 21 years of age,
  • Short BLESSED cognitive screening tool scores ≥10.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Nursing intervention program

    Usual Care Group

    Arm 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.

    Usual care participants received treatment as usual from their health care providers.

    Outcomes

    Primary Outcome Measures

    Patient Concerns Assessment (PCA)
    scores from 0 to 58 in which lower scores reflect fewer symptoms
    SF-12 Short Form Health Survey (SF-12)
    scores from 0 to 100 with higher scores representing better self-reported health
    State-Trait Anxiety Inventory (STAI)
    Scores range from 20 to 80. Higher scores indicating greater anxiety.

    Secondary Outcome Measures

    Number of ICD shocks
    The number of ICD shocks (if any) that the patient received from the ICD
    Center for Epidemiologic Studies Depression Scale (CES-D)
    Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
    Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
    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.
    Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias
    The number of times a person went to the ER for evaluation over 12 months
    Number of clinic visits related to the ICD
    The number of times a person had an outpatient clinic visit for the ICD
    Number of hospital admissions for ICD or cardiac related
    The number of times a person stayed overnight, at least 24 hours, in the hospital.
    Sudden Cardiac Arrest (SCA) Knowledge
    Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.
    Heart rhythm stability
    self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits
    Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
    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.

    Full Information

    First Posted
    June 16, 2020
    Last Updated
    July 7, 2020
    Sponsor
    University of Washington
    Collaborators
    National Institute of Nursing Research (NINR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04462887
    Brief Title
    Nursing Interventions Following Sudden Cardiac Arrest
    Official Title
    Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 1998 (Actual)
    Primary Completion Date
    December 31, 2003 (Actual)
    Study Completion Date
    December 31, 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    National Institute of Nursing Research (NINR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ICD

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    168 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nursing intervention program
    Arm Type
    Experimental
    Arm 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 Title
    Usual Care Group
    Arm Type
    No Intervention
    Arm Description
    Usual care participants received treatment as usual from their health care providers.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nursing intervention program
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Patient Concerns Assessment (PCA)
    Description
    scores from 0 to 58 in which lower scores reflect fewer symptoms
    Time Frame
    Change in patient concerns from baseline to 12 months
    Title
    SF-12 Short Form Health Survey (SF-12)
    Description
    scores from 0 to 100 with higher scores representing better self-reported health
    Time Frame
    change in general health (SF-12) score from baseline to 12 months
    Title
    State-Trait Anxiety Inventory (STAI)
    Description
    Scores range from 20 to 80. Higher scores indicating greater anxiety.
    Time Frame
    change in anxiety (STAI) score from baseline to 12 months
    Secondary Outcome Measure Information:
    Title
    Number of ICD shocks
    Description
    The number of ICD shocks (if any) that the patient received from the ICD
    Time Frame
    change in number of ICD shocks from baseline to 12 months
    Title
    Center for Epidemiologic Studies Depression Scale (CES-D)
    Description
    Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
    Time Frame
    change in depression (CES-D) score from baseline to 12 months
    Title
    Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
    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.
    Time Frame
    change in efficacy expectations from baseline to 12 months
    Title
    Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias
    Description
    The number of times a person went to the ER for evaluation over 12 months
    Time Frame
    change in number of ER visits from baseline to 12 months
    Title
    Number of clinic visits related to the ICD
    Description
    The number of times a person had an outpatient clinic visit for the ICD
    Time Frame
    change in number of clinic visits from baseline to 12 months
    Title
    Number of hospital admissions for ICD or cardiac related
    Description
    The number of times a person stayed overnight, at least 24 hours, in the hospital.
    Time Frame
    change in number of hospital admission from baseline to 12 months
    Title
    Sudden Cardiac Arrest (SCA) Knowledge
    Description
    Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.
    Time Frame
    change in SCA knowledge from baseline to 12 months
    Title
    Heart rhythm stability
    Description
    self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits
    Time Frame
    change in heart rhythm stability from baseline to 12 months
    Title
    Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
    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.
    Time Frame
    change in self-management behavior from baseline to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the ability to read, speak, and write English, having telephone access, willingness to be followed for 1 year. Exclusion Criteria: significant clinical comorbidities that prevented their return home after hospitalization, younger than 21 years of age, Short BLESSED cognitive screening tool scores ≥10.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cynthia M. Dougherty, PhD, ARNP
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11554535
    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.
    Results Reference
    background
    PubMed Identifier
    16359281
    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.
    Results Reference
    result
    PubMed Identifier
    15613121
    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.
    Results Reference
    result
    PubMed Identifier
    35948889
    Citation
    Dougherty CM, Liberato ACS, Streur MM, Burr RL, Kwan KY, Zheng T, Auld JP, Thompson EA. Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial. BMC Cardiovasc Disord. 2022 Aug 10;22(1):369. doi: 10.1186/s12872-022-02782-8.
    Results Reference
    derived

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    Nursing Interventions Following Sudden Cardiac Arrest

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