An interventional study of Nursing intervention program in ICD, sponsored by University of Washington. Completed. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 168 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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 participants received treatment as usual from their health care providers.
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.
Patient Concerns Assessment (PCA)
scores from 0 to 58 in which lower scores reflect fewer symptoms
Time frame: 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
Time frame: 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.
Time frame: change in anxiety (STAI) score from baseline to 12 months
Number of ICD shocks
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
Center for Epidemiologic Studies Depression Scale (CES-D)
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
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.
Time frame: change in efficacy expectations from baseline to 12 months
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
Time frame: change in number of ER visits from baseline to 12 months
Number of clinic visits related to the ICD
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
Number of hospital admissions for ICD or cardiac related
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
Sudden Cardiac Arrest (SCA) Knowledge
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
Heart rhythm stability
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
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.
Time frame: change in self-management behavior from baseline to 12 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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