Understanding patient and caregiver burden of chronic limb-threatening ischemia-a mixed-methods, patient-centered approach

The National Heart, Lung, and Blood Institute awarded Massachusetts General Hospital (The General Hospital Corporation) $185,196 on January 7, 2027 under the Cardiovascular Diseases Research program (CFDA 93.837).

The award funds a pilot multi-center cohort study examining patient and caregiver burden in chronic limb-threatening ischemia (CLTI). Aim 1 will assess how caregiver support relates to patient outcomes including quality of life, amputation, readmission, and mortality, collecting prospective data from 245 patients across two time points over six months. Aim 2 will use journey mapping and in-depth interviews with 15 patient-caregiver dyads to explore their lived experience and contributors to high or low caregiver burden.

Work is performed in Boston, Massachusetts. The period of performance runs from January 7, 2027 through January 6, 2028. The award is a Project Grant, a competitive research training grant mechanism. The assistance type is Project Grant.

Abstract

Chronic limb-threatening ischemia (clti), the most severe form of peripheral artery disease, affects over two million adults in the U.S. And leads to high rates of amputation, mortality, and diminished quality of life (QOL). Patients with clti experience debilitating pain and mobility loss, requiring extensive support that is often provided by informal caregivers. Despite the essential role caregivers play in managing wound care, medications, mobility, and emotional support, their contributions remain poorly understood and undervalued in clti care. In other chronic diseases like dementia and stroke, caregiver support is known to improve treatment adherence, reduce hospitalizations, and enhance patient outcomes. However, similar evidence is lacking for clti. Preliminary interviews with clti patients suggest that access to informal caregiver support is a key determinant of patient QOL after major interventions such as limb amputation. Furthermore, caregiver burden is likely high in clti but has not been systematically studied. The long-term goal of this project is to improve outcomes for both patients with clti and their caregivers. The central hypothesis is that greater caregiver support improves patient QOL and outcomes, while caregiver burden in clti is substantial and modifiable. This project involves a pilot multi-center cohort study of patients with clti and their informal caregivers, with two aims: aim 1 will assess how caregiver support relates to patient outcomes including QOL, amputation, readmission, and mortality, collecting prospective data from 245 patients across 2 time points over 6 months. Aim 2 will use journey mapping and in-depth interviews in a subset of 15 patient- caregiver dyads to explore their lived experience and contributors to high or low caregiver burden. This study aligns with the NIH's mission to enhance health and reduce illness burden by informing policies and interventions that recognize and support informal caregiving in high-risk vascular disease.