Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial
Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial
Background: An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial.
Methods: We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356.
Findings: We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43-0·90). Ten versus 27 patients died during follow-up.
Interpretation: Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice.
Integrated telehealth care for chronic illness and depression in geriatric home care patients: the Integrated Telehealth Education and Activation of Mood (I-TEAM) study
Objectives: To evaluate an integrated telehealth intervention (Integrated Telehealth Education and Activation of Mood (I-TEAM)) to improve chronic illness (congestive heart failure, chronic obstructive pulmonary disease) and comorbid depression in the home healthcare setting.
Design: Randomized controlled trial.
Setting: Hospital-affiliated home healthcare setting.
Participants: Medically frail older homebound individuals (N = 102).
Intervention: The 3-month intervention consisted of integrated telehealth chronic illness and depression care, with a telehealth nurse conducting daily telemonitoring of symptoms, body weight, and medication use; providing eight weekly sessions of problem-solving treatment for depression; and providing for communication with participants’ primary care physicians, who also prescribed antidepressants. Control participants were allocated to usual care with in-home nursing plus psychoeducation (UC+P).
Measurements: The two groups were compared at baseline and 3 and 6 months after baseline on clinical measures (depression, health, problem-solving) and 12 months after baseline on health utilization (readmission, episodes of care, and emergency department (ED) visits).
Results: Depression scores were 50% lower in the I-TEAM group than in the UC+P group at 3 and 6 months. Those who received the I-TEAM intervention significantly improved their problem-solving skills and self-efficacy in managing their medical condition. The I-TEAM group had significantly fewer ED visits (P = .01) but did not have significantly fewer days in the hospital at 12 months after baseline.
Conclusion: Integrated telehealth care for older adults with chronic illness and comorbid depression can reduce symptoms and postdischarge ED use in home health settings.