Abstract

Introduction: Health characteristics and symptoms of patients with an ICD differ based on ICD indication (primary or secondary prevention). The purpose of this study was to examine for differential effects of ICD indication on health outcomes in 2 post-implant interventions: a patient-only intervention (P-only) and a patient intervention that included the patient’s partner (P+P). Hypothesis: Intervention effects on patient health outcomes will be influenced by ICD indication. Methods: A prospective RCT (N = 301) compared the 2 interventions on: Physical Function (SF-36 Physical functioning , Vitality and Physical Component Score - PCS; physical health, Patient Concerns Assessment - PCA) and Psychological Adjustment (SF-36 Social Functioning and Mental Component Score - MCS; State Anxiety, STAI; and Depression, PHQ-9). Study participants were randomized to intervention condition, blocked by comorbidities and ICD indication. The 2 nurse-led social cognitive theory interventions (P-only or P+P) were delivered by telephone during the first 12 weeks post implant. Health outcomes were measured at baseline, 3, and 12 months. Using repeated measures ANOVA, comparisons were made among 4 study groups, defined by ICD indication (primary vs secondary) and intervention condition (P-only vs P+P). Results: The sample was primarily white (91%), male (88%), average age 64±11.90 years, BMI = 29.57±6.17, EF = 34.08±14.33, Charlson Comorbidity = 2.29±1.49, with 60% receiving ICD for primary prevention. Secondary, compared to primary, prevention patients in both interventions showed improved physical functioning, vitality, physical health, and depression (F = 8.5, P = <0.001; F = 5.75, P = 0.001; F = 6.15, P = < 0.001; F = 4.09, P = 0.007, respectively). The greatest improvements were observed at 3 months (end of interventions) and maintained or improved at 12 months. Secondary prevention patients participating in P+P showed the greatest improvement in vitality and depression across 12 months. Conclusion: Patients who received an ICD for secondary prevention and were also in the P+P intervention showed greatest improvement across recovery, indicating promising health outcomes for patients in intervention programs that include the partner.

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