ICD
Conditions
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.
Interventions
BEHAVIORALNursing 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.
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Concerns Assessment (PCA) | Change in patient concerns from baseline to 12 months | scores from 0 to 58 in which lower scores reflect fewer symptoms |
| SF-12 Short Form Health Survey (SF-12) | change in general health (SF-12) score from baseline to 12 months | scores from 0 to 100 with higher scores representing better self-reported health |
| State-Trait Anxiety Inventory (STAI) | change in anxiety (STAI) score from baseline to 12 months | Scores range from 20 to 80. Higher scores indicating greater anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias | change in number of ER visits from baseline to 12 months | The number of times a person went to the ER for evaluation over 12 months |
| Number of clinic visits related to the ICD | change in number of clinic visits from baseline to 12 months | The number of times a person had an outpatient clinic visit for the ICD |
| Number of hospital admissions for ICD or cardiac related | change in number of hospital admission from baseline to 12 months | The number of times a person stayed overnight, at least 24 hours, in the hospital. |
| Number of ICD shocks | change in number of ICD shocks from baseline to 12 months | The number of ICD shocks (if any) that the patient received from the ICD |
| Heart rhythm stability | change in heart rhythm stability from baseline to 12 months | 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) | change in self-management behavior from baseline to 12 months | 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. |
| Sudden Cardiac Arrest (SCA) Knowledge | change in SCA knowledge from baseline to 12 months | Score ranges from 0 to 25. Higher the score greater is the ICD knowledge. |
| Center for Epidemiologic Studies Depression Scale (CES-D) | change in depression (CES-D) score from baseline to 12 months | Scores range from 0 to 60, with high scores indicating greater depressive symptoms. |
| Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale) | change in efficacy expectations from baseline to 12 months | 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. |
Outcome results
None listed