Development and feasibility study of the heart failure management program 'SupportHeart'

Type of funding sources: None.

Disease management programs for HF are characterized by heterogeneity and different levels of complexity, thus the results regarding of their effectiveness are controversial. The trajectory of HF makes supportive care controversial. Supportive care consists the following four aspects: Communication, education, psychological and spiritual issues and symptom management.

To evaluate the effectiveness of an individualized supportive care management program in terms of the four different components that comprise supportive care in patients with HF.

This was a multi-method, randomized control trial (RCT) study [control group (CG)and intervention group (IG)] to assess a new developed supportive care management program for patients with HF. Patients allocated in the IG received written material for HF self-management and an educational session was conducted by a nurse in the bedside of the patient. The intervention was consisted by monthly educational sessions including information about the HF syndrome, pharmacological and non- pharmacological treatment and self-management. The evaluation of the intervention included health-related quality of life (HR-QoL), self-care management, exercise, anxiety and depression and perceived support. Furthermore, acute events (readmissions and deaths) and deterioration of symptoms were measured. Statistical comparisons were performed using the "Kruskal Wallis Test", Chi-Square and the Fisher’s test. Kaplan Meir curves and the log-rank test were utilised to explore the time until the first acute event. Statistical analysis was conducted in the statistical software R v.3.6.1.

Thirty-five patients with HF participated in the study and the intervention lasted for six months. A better HR-QoL was found for both groups in the sixth time period, but with a difference in the social dimension of the HR-QoL favoring the IG [IG baseline= 4.8 (4.9) / 1st month=3.3 (3.5) / 6th month =2.8 (3.1)] [ CG baseline= 2.3 (1,1) / 1st month=3.4 (2,7) / 6th month =2.7 (2.8) ]. Also, a difference in the sub-scale of family/significant others in the IG was indicated, with an increased trend [IG baseline=50.9 (5.4) / 6th month= 52.7 (3.4)] [CG baseline =50.3 (8.9) / 6th month = 49.9 (4.2)]. No difference between the two groups was found for self-care management. The survival of the CG was lower than that of the IG in all three time points; 30 days: (log-rank test, X2(1) = 5.7, p = 0.02), 90 days: (log-rank test, X2(1) = 12.3, p<0.001) and 180 days: (log-rank test, X2(1) = 6.8, p = 0.009).

Discussion/Conclusion: This is the first RCT assessing the effectiveness of supportive care in patients with HF. Supportive care seems to be a promising concept for HF management programs. There was a great effect in acute events as it was found a reduced risk by 87% for a patient receiving supportive care. Also, the study illustrated the effectiveness regarding multiple outcomes, such as HR-QoL and perceived support.

Survival Analysis