Nursing Interventions Following Sudden Cardiac Arrest

ICD Clinical Trial

Official title:

Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462887
• Other study ID #: 13730
• Secondary ID: R01NR004766
• Status: Completed
• Phase: N/A
• Start date: January 1, 1998
• Est. completion date: December 31, 2003

Study information

• Verified date: July 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 31, 2003
• Est. primary completion date: December 31, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• ICD

Intervention

Behavioral:
• Nursing intervention program
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Concerns Assessment (PCA)	scores from 0 to 58 in which lower scores reflect fewer symptoms	Change in patient concerns from baseline to 12 months
Primary	SF-12 Short Form Health Survey (SF-12)	scores from 0 to 100 with higher scores representing better self-reported health	change in general health (SF-12) score from baseline to 12 months
Primary	State-Trait Anxiety Inventory (STAI)	Scores range from 20 to 80. Higher scores indicating greater anxiety.	change in anxiety (STAI) score from baseline to 12 months
Secondary	Number of ICD shocks	The number of ICD shocks (if any) that the patient received from the ICD	change in number of ICD shocks from baseline to 12 months
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	change in depression (CES-D) score from baseline to 12 months
Secondary	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.	change in efficacy expectations from baseline to 12 months
Secondary	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	change in number of ER visits from baseline to 12 months
Secondary	Number of clinic visits related to the ICD	The number of times a person had an outpatient clinic visit for the ICD	change in number of clinic visits from baseline to 12 months
Secondary	Number of hospital admissions for ICD or cardiac related	The number of times a person stayed overnight, at least 24 hours, in the hospital.	change in number of hospital admission from baseline to 12 months
Secondary	Sudden Cardiac Arrest (SCA) Knowledge	Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.	change in SCA knowledge from baseline to 12 months
Secondary	Heart rhythm stability	self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits	change in heart rhythm stability from baseline to 12 months
Secondary	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.	change in self-management behavior from baseline to 12 months