Use of Actigraphy (Wearable Digital Sensors to Monitor Activity) in Heart Failure Randomized Clinical Trials: A Scoping Review

Abstract Background Actigraphy-based measurements of physiologic parameters may enable design of patient-centric heart failure (HF) clinical trials. Recently, the Heart Failure Collaboratory (HFC) focused on recommendations for meaningful change and use of actigraphy as an endpoint in HF clinical trials. We aimed to evaluate randomized controlled trials (RCTs) that have quantified the impact of HF interventions using actigraphy. Methods Using a scoping review strategy, we evaluated the use of actigraphy in HF RCTs. Studies were identified through electronic searches of Embase, OVID MEDLINE, PubMed, and Cochrane review. Data on trial characteristics and results were collected. Results We identified 11 RCTs with a total of 1,455 participants. The risk of bias across the included trials was overall high. All trials had the primary outcomes reflecting measures of either physical activity (n=8), sleep (n=2), or both (n=1). Five trials evaluated response to pharmacologic therapies compared to placebo, three evaluated physical activity interventions, two evaluated group or cognitive therapy, and one evaluated sleep-ventilation strategy. Sample sizes ranged from 30 to 619 participants. There was significant heterogeneity relating to device type, body placement site, and handling of missing actigraphy data. Duration of monitoring ranged from 48 hours to 12 weeks. None of the studies evaluating pharmacologic therapies (n=5) demonstrated a significant improvement of actigraphy-based primary endpoints measurements. Conclusions There is significant heterogeneity in the use, methodology, and results of actigraphy-based HF RCTs. Our results highlight the need to develop, standardize, and validate actigraphy-specific outcomes for use in HF clinical trials