Abstract Introduction Heart failure (HF) and diabetes mellitus (DM) most of the times occur together, aggravating patients’ outcomes and the interaction of the two conditions, which is complex, make the application of effective management programs necessary, in order to improve patients’ outcomes. Purpose The aim of the current study was to evaluate the effectiveness of an individualized supportive care management program in patients with HF and DM, in order to improve patients’ self-management compared to the ‘usual’ care. Methods The current study is a sub-analysis of the randomized clinical trial named ‘SupportHeart’ using pragmatic methodology. It was consisted by the intervention group (IG) and the control group (CG). The study investigated the patients for a period of one year at 5 time points (in baseline, 1 month, 3 months, 6 months and 1 year). Self –care management was measured with the Greek versions of two tools: the ‘Self-care of Heart Failure Index’ (Gr-SCHFI) and the ‘European Heart Failure Self-Care Behavior Scale’ (Gr9EHFScBS). Linear Mixed Models Effects (LMME) were also used. Results The sample consisted of 121 patients with HF and DM and 66% were male patients. The Linear Mixed Model results have shown that there was a statistically significant effect of the intervention at all the time points after the intervention p < 0.001 in all the dimensions of the SCHFI; in the dimension of maintenance [1 month=2.6 (0.81, 4.4) p= 0.005, 3 months = 5.2 (3.4, 7.1) p < 0.001, 6 months = 8.1 (6.2, 10) p < 0.001, 1 year = 7.5 (5.7, 9.4) p < 0.001], on the management [1 month = 4.1(2.8, 5.4) p < 0.001, 3 months = 5.1 (3.8, 6.4) p < 0.001, 6 months = 7.5 (6.1, 8.9) p < 0.001, 1 year = 10 (8.7, 11) p < 0.001 and on the self-confidence [1 month =4.9 (3.4, 6.5) p < 0.001, 3 months = 7.8 (6.2, 9.4) p < 0.001, 6 months = 8.5 (6.9, 10) p < 0.001 and in 1 year = 9.1 (7.5, 11) p < 0.001]. The Linear Mixed Model results showed also a statistically significant effect of the intervention at all the time points after the intervention p < 0.001 in all the dimensions of the GR9EHFScBS: in the dimension of adhering to recommendations [1 month=1.5 (0.71, 2.3) p < 0.001, 3 months = 1.4 (0.59, 2.3) p < 0.001, 6 months=1.6 (0.69, 2.4) p < 0.001, in 1 year = 4.3 (3.5, 5.1) p < 0.001], on the fluid and sodium management [1 month = 2.3 (1.3, 3.2) p < 0.001, 3 months = 3.6 (2.6, 4.6) ) p < 0.001, 6 months = 4.5 (3.5, 5.5) p < 0.001, in 1 year = 6.4 (5.4, 7.4) ) p < 0.001 and on the physical activity and recognition of deteriorating symptoms [1 month = 2.6 (1.7, 3.6) p < 0.001, 3 months = 3.4 (2.4, 4.3) p < 0.001, 6 months = 3.9 (2.9, 4.9) p < 0.001, 1 year = 5.8 (4.8, 6.7) p < 0.001]. Conclusion Supportive care seems to be a promising concept for HF-DM management programs. The pragmatic methodology that was used in the research study has an intensive intervention which started rapidly and in early stages, on a person-centred basis.
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