Nursing Interventions Following Sudden Cardiac Arrest

Not Applicable

Completed

• Conditions: ICD
• Interventions: Behavioral: Nursing intervention program

• Registration Number: NCT04462887
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 1998-01-01
• Primary Completion: 2003-12-31
• Study Completion: 2003-12-31
• Study First Submitted: 2020-06-16
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nursing intervention program	Nursing intervention program	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.

Primary Outcome Measures

Name	Time	Method
SF-12 Short Form Health Survey (SF-12)	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)	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)	Change in patient concerns from baseline to 12 months	scores from 0 to 58 in which lower scores reflect fewer symptoms

Secondary Outcome Measures

Name	Time	Method
Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)	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.
Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias	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
Number of ICD shocks	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
Center for Epidemiologic Studies Depression Scale (CES-D)	change in depression (CES-D) score from baseline to 12 months	Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Number of hospital admissions for ICD or cardiac related	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.
Sudden Cardiac Arrest (SCA) Knowledge	change in SCA knowledge from baseline to 12 months	Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.
Heart rhythm stability	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
Number of clinic visits related to the ICD	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
Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)	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.