Clinical trial NCT04462887: Nursing Interventions Following Sudden Cardiac Arrest
Official title: Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICD
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-07-08
Enrollment: 168
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Patient Concerns Assessment (PCA)
timeFrame: Change in patient concerns from baseline to 12 months
measure: SF-12 Short Form Health Survey (SF-12)
timeFrame: change in general health (SF-12) score from baseline to 12 months
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: change in anxiety (STAI) score from baseline to 12 months
Secondary outcomes:
measure: Number of ICD shocks
timeFrame: change in number of ICD shocks from baseline to 12 months
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: change in depression (CES-D) score from baseline to 12 months
measure: Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
timeFrame: change in efficacy expectations from baseline to 12 months
measure: Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias
timeFrame: change in number of ER visits from baseline to 12 months
measure: Number of clinic visits related to the ICD
timeFrame: change in number of clinic visits from baseline to 12 months
measure: Number of hospital admissions for ICD or cardiac related
timeFrame: change in number of hospital admission from baseline to 12 months
measure: Sudden Cardiac Arrest (SCA) Knowledge
timeFrame: change in SCA knowledge from baseline to 12 months
measure: Heart rhythm stability
timeFrame: change in heart rhythm stability from baseline to 12 months
measure: Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
timeFrame: change in self-management behavior from baseline to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Cynthia M. Dougherty, PhD, ARNP
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.