A Patient-Centred Supportive Care Management Program Reduces Acute Events in Patients with Heart Failure and Diabetes Mellitus: A Sub-Analysis of ‘SupportHeart’ Study

Abstract

Introduction: New effective approaches are necessary for improving the care and complications in patients with Heart Failure (HF) and Diabetes Mellitus (DM) who must deal everyday with various complex factors. Aim: 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 the reduction of acute events and mortality compared to the ‘usual’ care. Methodology: The current study is a sub-analysis of the Randomized Clinical Trial (RCT) named ‘SupportHeart’ using pragmatic methodology consisted by the Intervention Group (IG) and the Control Group (CG). The study investigated the patients for a period of one year at 5 different time points. Welsch t-test when the variables were continuous and the Fisher’s exact test in the case of categorical variables were used. Linear Mixed Models Effects were performed and adjusted by various factors related to the participants. Results: The sample consisted of 121 patients with HF and DM. Survival analysis was studied categorizing it, into acute events and death events due to HF. At the period from recruitment to 1 month, there were 3/65 (4.6 %) acute events for the CG and 2/56 (3.6%) acute events for the IG p>0.9. After 1 month and until 3 months’ time point after the intervention, the CG 7/64 (10.9%) had more acute events compared to the IG 3/56 (5.4%) p=0.51. After 3 months and until the 6-month time point after the intervention, the CG 12/61 (19.7%) had more acute events compared to the IG 6/52 (11.5%) p=0.3. Between 6 months and until 1 year time point after the intervention, the IG (0/49) (0.0%) hadn’t any acute event compared to the CG that had 8/58 (13.8%) p=0.007 acute events. There were no significant differences in the mortality across the two groups in all time points; at the period from recruitment to 1 month, there was 1/ 65 (1.5%) death event for the CG and no death for the IG 0/56 (0.0%) p>0.9. After 1 month and until 3 months’ time point after the intervention, the CG had 2/64 (3.1 %) deaths and the IG 3/56 (5.4%) p=0.66. After 3 months and until the 6-month time point after the intervention, the CG had 3/61 (4.9%) deaths compared with the IG that had 1/52 (1.9%) death p=0.62. Between 6 months and until 1 year time point after the intervention, the CG had 1/58 (1.7%) death event and the IG had 1/49 (2.0%) with p>0.9. Conclusions: Supportive care seems to be a promising concept for HF-DM management programs. The pragmatic methodology that was used in the ‘SupportHeart’ study had an intensive intervention, started rapidly in early stages on a person-centred basis, reduced acute events and deaths in patients with HF and DM.