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Clinical Trials/NCT04462887
NCT04462887
Completed
Not Applicable

Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest

University of Washington0 sites168 target enrollmentJanuary 1, 1998
ConditionsICD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ICD
Sponsor
University of Washington
Enrollment
168
Primary Endpoint
SF-12 Short Form Health Survey (SF-12)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 1998
End Date
December 31, 2003
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cynthia M. Dougherty

Professor

University of Washington

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.

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

  • Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)(change in efficacy expectations from baseline to 12 months)
  • Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias(change in number of ER visits from baseline to 12 months)
  • Number of ICD shocks(change in number of ICD shocks from baseline to 12 months)
  • Center for Epidemiologic Studies Depression Scale (CES-D)(change in depression (CES-D) score from baseline to 12 months)
  • Number of hospital admissions for ICD or cardiac related(change in number of hospital admission from baseline to 12 months)
  • Sudden Cardiac Arrest (SCA) Knowledge(change in SCA knowledge from baseline to 12 months)
  • Heart rhythm stability(change in heart rhythm stability from baseline to 12 months)
  • Number of clinic visits related to the ICD(change in number of clinic visits from baseline to 12 months)
  • Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)(change in self-management behavior from baseline to 12 months)

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