The impact of telehealth care on health-related quality of life of patients with heart failure: Results from the Danish TeleCare North heart failure trial

Aim The aim of this study was to assess the impact on health-related quality of life (HRQoL) of a telehealth care solution compared with usual practice of patients with heart failure (HF). Methods A randomized controlled trial with a telehealth care solution (Telekit) as the intervention (with a focus on self-empowerment achieved by engaging patients in their own illness through self-monitoring) combined with usual care and usual care as the control. The primary outcome was a change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score. Secondary outcomes were changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) score, all of which were assessed from baseline to approximately 12 months' follow-up between the two groups. Outcomes were assessed via unadjusted and adjusted analyses. Results At baseline, 299 (145 interventions, 154 controls) patients were enrolled. In the primary analysis (n = 299), the adjusted intervention effects were PCS -0.81 (95% CI -2.7-1.1), MCS 4.66 (95% CI 1.8-7.5) and KCCQ12 3.67 (95% CI -0.7-8.1). Only the change in MCS was statistically significant. An unadjusted analysis replicated the primary analysis. Complete case analyses (n = 193) generally resulted in a lower intervention effect on the PCS score, but the difference remained statistically insignificant. Conclusions Only the MCS score was significantly higher in the telehealth care group compared to the control group. ClinicalTrials.gov (NCT02860013), July 28, 2016