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.