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OpenTrials
Completed

NCT Number: NCT04462887

Nursing Interventions Following Sudden Cardiac Arrest

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.

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Key information

Conditions

ICD

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nursing intervention program

Behavioral

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 outcomes

  1. Patient Concerns Assessment (PCA)

    Time frame: Change in patient concerns from baseline to 12 months

    scores from 0 to 58 in which lower scores reflect fewer symptoms

  2. SF-12 Short Form Health Survey (SF-12)

    Time frame: change in general health (SF-12) score from baseline to 12 months

    scores from 0 to 100 with higher scores representing better self-reported health

  3. State-Trait Anxiety Inventory (STAI)

    Time frame: change in anxiety (STAI) score from baseline to 12 months

    Scores range from 20 to 80. Higher scores indicating greater anxiety.

Secondary outcomes

  1. Number of ICD shocks

    Time frame: change in number of ICD shocks from baseline to 12 months

    The number of ICD shocks (if any) that the patient received from the ICD

  2. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: change in depression (CES-D) score from baseline to 12 months

    Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

  3. Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)

    Time frame: change in efficacy expectations from baseline to 12 months

    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.

  4. 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

    The number of times a person went to the ER for evaluation over 12 months

  5. Number of clinic visits related to the ICD

    Time frame: change in number of clinic visits from baseline to 12 months

    The number of times a person had an outpatient clinic visit for the ICD

  6. Number of hospital admissions for ICD or cardiac related

    Time frame: change in number of hospital admission from baseline to 12 months

    The number of times a person stayed overnight, at least 24 hours, in the hospital.

  7. Sudden Cardiac Arrest (SCA) Knowledge

    Time frame: change in SCA knowledge from baseline to 12 months

    Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.

  8. Heart rhythm stability

    Time frame: change in heart rhythm stability from baseline to 12 months

    self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits

  9. Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)

    Time frame: change in self-management behavior from baseline to 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest

Important dates

Study start
1998
Primary completion
2003
Study completion
2003
First posted
Jul 8, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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