Nursing Interventions Following Sudden Cardiac Arrest

NCT04462887 | Completed

• 2 other identifiers: 13730R01NR004766
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ICD

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• 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

• 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 clinic visits related to the ICD

  change in number of clinic visits from baseline to 12 months

Study Arms (2)

Nursing intervention program

EXPERIMENTAL

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.

Behavioral: Nursing intervention program

Usual Care Group

NO INTERVENTION

Usual care participants received treatment as usual from their health care providers.

Interventions

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.

Nursing intervention program

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• significant clinical comorbidities that prevented their return home after hospitalization,
• younger than 21 years of age,
• Short BLESSED cognitive screening tool scores ≥10.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Related Publications (4)

• 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.

  PMID: 11554535 BACKGROUND

• 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.

  PMID: 16359281 RESULT

• 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.

  PMID: 15613121 RESULT

• 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.

  PMID: 35948889 DERIVED

Study Officials

• Cynthia M. Dougherty, PhD, ARNP

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 8, 2020
• Study Start: January 1, 1998
• Primary Completion: December 31, 2003
• Study Completion: December 31, 2003
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share