HeartSense-HF
Research type
Research Study
Full title
Heart failure patient-reported outcomes and lived experience of remote monitoring with HeartLogicTM
IRAS ID
347566
Contact name
Fadi Jouhra
Contact email
Sponsor organisation
St George’s University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 3 months, 90 days
Research summary
This is a pilot, observational, cross-sectional, comparative cohort feasibility study conducted at two NHS Trusts: St George's University Hospitals NHS Foundation Trust and Liverpool Heart and Chest Hospital NHS Foundation Trust. The aim of this pilot study is to assess the feasibility and acceptability of conducting a larger-scale study evaluating the impact of HeartLogic™ remote monitoring on patient-reported outcomes and experiences in individuals with chronic heart failure (HF) and cardiac implantable electronic devices (CIEDs).
Patients will be identified through hospital records and local device databases and invited to participate if they meet the eligibility criteria, including having a CIED (ICD or CRT, with or without HeartLogic™ monitoring) implanted between 12 and 36 months prior.
Data collection will be conducted at a single time point, using validated patient-reported outcome measures (PROMs) and a patient-reported experience measure (PREM). These include the Kansas City Cardiomyopathy Questionnaire (KCCQ), EuroQol 5-Dimension 5-Level (EQ-5D-5L) with Visual Analog Scale (VAS), and a designed HeartLogic™ patient experience questionnaire to assess usability, satisfaction, and perceived value of the monitoring system.
As part of feasibility outcomes, this study will also explore recruitment rates, response rates, data completeness, and acceptability of PROM and PREM collection methods. Finally, by comparing patient-reported outcomes and experiences between patients with and without HeartLogic™ monitoring, this study will provide preliminary insights into the potential impact of HeartLogic™ on quality of life and patient experience, supporting the development of patient-centered approaches in remote HF management.
REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0052
Date of REC Opinion
13 May 2025
REC opinion
Favourable Opinion