Remote motivational interviewing to improve patient self-care and caregiver contributions in heart failure: the REMOTIVATE-HF trial protocol

In patients with heart failure (HF), self-care and caregiver contributions to self-care defined as the daily management of the disease by patients and caregivers are essential for improving patient outcomes, including mortality, quality of life, and hospitalizations. However, patients and caregivers often demonstrate inadequate self-care and caregiver contributions, respectively, and experience difficulties performing related tasks. Face-to-face motivational interviewing (MI) has been shown to effectively improve both patient self-care and caregiver contributions, but many patients and caregivers live far from HF centers or face transportation barriers. In such cases, remote MI delivered via videoconferencing may represent a viable alternative; however, evidence regarding its effectiveness remains scarce and inconclusive. The aim of this randomized controlled trial is to evaluate whether remote MI delivered via videocalls in patients with HF: (1) improves patient self-care maintenance (primary endpoint); and (2) improves secondary outcomes, including (a) for patients: self-care management, self-care monitoring, self-efficacy, HF symptoms, generic and disease-specific quality of life, anxiety and depression, healthcare service utilization, and mortality; and (b) for caregivers: contributions to self-care, self-efficacy, and preparedness.

This multicenter randomized controlled trial is being conducted in six Italian HF centers. Patient–caregiver dyads are randomly assigned to one of two groups: Arm 1 (remote motivational interviewing for patients and caregivers) or Arm 2 (usual care). The intervention consists of seven video-based sessions of MI over twelve months: four intensive sessions within the first two months, followed by three maintenance sessions at months five, eight, and eleven. Trained nurses will deliver MI addressing individual self-care using the Self-Care of Heart Failure Index, version 7.2 (score range 0-100; higher scores indicate better self-care), along with a battery of psychometrically validated instruments. All measures are collected at baseline and every three months (one month after each intervention) over a 12-month follow-up period.

The planned final sample, accounting for attrition, will include 432 patient–caregiver dyads. If remote MI proves effective in improving patient self-care and caregiver contributions to self-care, this low-cost intervention delivered via videocalls may represent a scalable strategy to improve key outcomes in patients with HF and their caregivers.