Nursing Interventions Following Sudden Cardiac Arrest
Primary Purpose
ICD
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nursing intervention program
Sponsored by
About this trial
This is an interventional supportive care trial for 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nursing intervention program
Usual Care Group
Arm Description
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.
Usual care participants received treatment as usual from their health care providers.
Outcomes
Primary Outcome Measures
Patient Concerns Assessment (PCA)
scores from 0 to 58 in which lower scores reflect fewer symptoms
SF-12 Short Form Health Survey (SF-12)
scores from 0 to 100 with higher scores representing better self-reported health
State-Trait Anxiety Inventory (STAI)
Scores range from 20 to 80. Higher scores indicating greater anxiety.
Secondary Outcome Measures
Number of ICD shocks
The number of ICD shocks (if any) that the patient received from the ICD
Center for Epidemiologic Studies Depression Scale (CES-D)
Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
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.
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
Number of clinic visits related to the ICD
The number of times a person had an outpatient clinic visit for the ICD
Number of hospital admissions for ICD or cardiac related
The number of times a person stayed overnight, at least 24 hours, in the hospital.
Sudden Cardiac Arrest (SCA) Knowledge
Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.
Heart rhythm stability
self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits
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.
Full Information
NCT ID
NCT04462887
First Posted
June 16, 2020
Last Updated
July 7, 2020
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04462887
Brief Title
Nursing Interventions Following Sudden Cardiac Arrest
Official Title
Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 1998 (Actual)
Primary Completion Date
December 31, 2003 (Actual)
Study Completion Date
December 31, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nursing intervention program
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Usual care participants received treatment as usual from their health care providers.
Intervention Type
Behavioral
Intervention Name(s)
Nursing intervention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Concerns Assessment (PCA)
Description
scores from 0 to 58 in which lower scores reflect fewer symptoms
Time Frame
Change in patient concerns from baseline to 12 months
Title
SF-12 Short Form Health Survey (SF-12)
Description
scores from 0 to 100 with higher scores representing better self-reported health
Time Frame
change in general health (SF-12) score from baseline to 12 months
Title
State-Trait Anxiety Inventory (STAI)
Description
Scores range from 20 to 80. Higher scores indicating greater anxiety.
Time Frame
change in anxiety (STAI) score from baseline to 12 months
Secondary Outcome Measure Information:
Title
Number of ICD shocks
Description
The number of ICD shocks (if any) that the patient received from the ICD
Time Frame
change in number of ICD shocks from baseline to 12 months
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time Frame
change in depression (CES-D) score from baseline to 12 months
Title
Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
Description
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.
Time Frame
change in efficacy expectations from baseline to 12 months
Title
Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias
Description
The number of times a person went to the ER for evaluation over 12 months
Time Frame
change in number of ER visits from baseline to 12 months
Title
Number of clinic visits related to the ICD
Description
The number of times a person had an outpatient clinic visit for the ICD
Time Frame
change in number of clinic visits from baseline to 12 months
Title
Number of hospital admissions for ICD or cardiac related
Description
The number of times a person stayed overnight, at least 24 hours, in the hospital.
Time Frame
change in number of hospital admission from baseline to 12 months
Title
Sudden Cardiac Arrest (SCA) Knowledge
Description
Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.
Time Frame
change in SCA knowledge from baseline to 12 months
Title
Heart rhythm stability
Description
self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits
Time Frame
change in heart rhythm stability from baseline to 12 months
Title
Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)
Description
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.
Time Frame
change in self-management behavior from baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia M. Dougherty, PhD, ARNP
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11554535
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.
Results Reference
background
PubMed Identifier
16359281
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.
Results Reference
result
PubMed Identifier
15613121
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.
Results Reference
result
PubMed Identifier
35948889
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.
Results Reference
derived
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Nursing Interventions Following Sudden Cardiac Arrest
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