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ClinicalTrials.gov Identifier NCT01878630.

Aims Depression is a frequent comorbidity in patients with chronic heart failure (CHF). Telemonitoring has emerged as a novel option in CHF care. However, patients with depression have been excluded in most telemedicine studies. This pre‐specified subgroup analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM‐HF) trial investigates the effect of telemonitoring on depressive symptoms over a period of 12 months. Methods and results The TIM‐HF study randomly assigned 710 patients with CHF to either usual care (UC) or a telemedical intervention (TM) using non‐invasive devices for daily monitoring electrocardiogram, blood pressure and body weight. Depression was evaluated by the 9‐item Patient Health Questionnaire (PHQ‐9) with scores ≥10 defining clinically relevant depressive symptoms. Mixed model repeated measures were performed to calculate changes in PHQ‐9 score. Quality of life was measured by the Short Form‐36. At baseline, 156 patients had a PHQ‐9 score ≥10 points (TM: 79, UC: 77) with a mean of 13.2 points indicating moderate depressiveness. Patients randomized to telemedicine showed an improvement of their PHQ‐9 scores, whereas UC patients remained constant (P = 0.004). Quality of life parameters were improved in the TM group compared to UC. Adjustment was performed for follow‐up, New York Heart Association class, medication, age, current living status, number of hospitalizations within the last 12 months and serum creatinine. In the study population without depression, the PHQ‐9 score was similar at baseline and follow‐up. Conclusion Telemedical care improved depressive symptoms and had a positive influence on quality of life in patients with CHF and moderate depression.

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Background The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial showed that, compared with usual care, a structured remote patient management (RPM) intervention done over 12-months reduced the percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause death. The aim of the study was to evaluate whether this clinical benefit seen for the RPM group during the initial 12 month follow-up of the TIM-HF2 trial would be sustained 1 year after stopping the RPM intervention.Methods TIM-HF2 was a prospective, randomised, multicentre trial done in 43 hospitals, 60 cardiology practices, and 87 general practitioners in Germany. Patients with heart failure, New York Heart Association functional class II or III, and who had been hospitalised for heart failure within 12 months before randomisation were randomly assigned to either the RPM intervention or usual care. At the final study visit (main trial), the RPM intervention was stopped and the 1 year extended follow-up period started, which lasted 1 year. The primary outcome was percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause mortality. Analyses were done using the intention-totreat principle. This trial is registered with ClinicalTrials.gov, number NCT01878630.

Tele-6MWT has a high predictive value with respect to hospitalization as a result of HF or death from any cause and the results were comparable with the prognostic impact of a conventional 6MWT. Therefore Tele-6MWT may be used as alternative test method in the home environment. However, there is no added prognostic value of repeating Tele-6MWTs on a monthly basis.

RPM will be a medical care concept for recently hospitalized HF- patients in the near future but the optimal telemedical setting of RPM and the duration of this intervention have to be defined in further clinical trials.

A high adherence can be achieved by individual training of the patient regarding the handling of his disease, the use of telemedical devices and an easy-to-use telemonitoring system. The majority of the informed self-determined CHF patients NYHA class II/III are adopting telemonitoring and are adherent in the long term.