Improving outcomes of AF ablation by integrated personalized lifestyle interventions: rationale and design of the prevention to improve outcomes of PVI (POP) trial.

Progression of atrial fibrillation (AF) and outcomes of ablation therapy are strongly affected by modifiable risk factors. Although previous studies show beneficial effects of modifying single risk factors, there is lack of evidence from randomized controlled trials on the effects of integrated AF lifestyle programmes. The POP trial is designed to evaluate the clinical outcomes of a dedicated nurse-led AF lifestyle outpatient clinic in patients with symptomatic AF. This study is a prospective, 1:1 randomized, single centre, investigator-initiated clinical trial in 150 patients with paroxysmal or persistent AF referred for a first pulmonary vein isolation (PVI). Prior to the ablation, patients in the intervention group receive a personalized risk factor treatment programme in a specialized, protocolized, nurse-led outpatient clinic. Patient education and durable lifestyle management is promoted with an e-health platform. Patients in the control group receive standard care by cardiologists before ablation. The primary endpoint is the number of hospitalizations for re-ablation and cardioversion, with a follow-up of 12 months after ablation. Secondary endpoints include mortality, number of acute ischemic events, stroke or hospitalizations for heart failure, quality of life, number of ablations cancelled because of symptom reduction, and ablation success rate at 12 months. Determinants of patient and staff experience are explored and a cost-effectiveness analysis is included. The POP trial will help ascertain the efficacy and cost-effectiveness of an integrated technology-supported lifestyle therapy in patients with symptomatic AF. The trial is funded by the Netherlands Organisation for Health Research and Development [10070012010001]. Home sleep apnoea testing devices were provided by Itamar Medical, Ltd.ClinicalTrials.gov Identifier NCT05148338. AF atrial fibrillation, OSA obstructive sleep apnoea, PFA pulsed field ablation, PVI pulmonary vein isolation.

The Value of Tracking Data on the Behavior of Patients Who Have Undergone Bariatric Surgery: Explorative Study.

BACKGROUND: To maintain the benefits of a bariatric procedure, patients have to change their lifestyle permanently. This happens within a context of coresponsibilities of health care professionals and their social support system. However, most interventions are focused on the patient as an individual. In this explorative pilot study, behavioral, contextual, and experiential data were gathered to obtain insight on coresponsibility. OBJECTIVE: The aim of this study is to explore the use of trackers by patients who have undergone bariatric surgery in a data-enabled design approach. METHODS: Behavioral and contextual data on the households of patients who have undergone bariatric surgery were explored using a smartphone with an interactive user interface (UI), weight scale, activity bracelet, smart socket, accelerometer motion sensor, and event button to find examples of opportunities for future interventions. RESULTS: A total of 6 households were monitored. Approximately 483,000 data points were collected, and the participants engaged in 1483 conversations with the system. Examples were found using different combinations of data types, which provided the obesity team a better understanding of patient behaviors and their support system, such as a referral to a family coach instead of a dietician. Another finding regarding the partners was, for example, that the conversational UI system facilitated discussion about the support structure by asking for awareness. CONCLUSIONS: An intelligent system using a combination of quantitative data gathered by data tracking products in the home environment and qualitative data gathered by app-enhanced short conversations, as well as face-to-face interviews, is useful for an improved understanding of coresponsibilities in the households of patients who have undergone bariatric surgery. The examples found in this explorative study so far encourage research in this field.