Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK.

NARecruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

July 11, 2024

Primary Completion Date

July 30, 2025

Study Completion Date

July 30, 2025

Conditions
Heart Failure
Interventions
DEVICE

Heartfelt Device installed

Device installed in the patient's home and capturing foot volume data which are processed in the cloud.

OTHER

Standard care

Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. They should also report changes in breathlessness, tiredness and other symptoms associated with heart failure decompensation.

OTHER

Questionnaires

Patients are presented with one or more optional questionnaires (some validated, some bespoke)

DEVICE

Heartfelt Device in pharmacy

Device used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud.

DEVICE

Heartfelt device alerting system

The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.

Trial Locations (9)

HU15 1AY

RECRUITING

The Ridings Medical Group, Brough

HU7 5DD

RECRUITING

Dr R Raut & Partnership (General Practice), Hull

CR7 7YE

RECRUITING

Croydon Health Services NHS Trust, Croydon

IP33 2QZ

RECRUITING

West Suffolk NHS Foundation Trust, Bury St Edmunds

RH6 9PT

RECRUITING

Modality East Surrey Medical Practice, Horley

BD21 1LA

RECRUITING

Modality Partnership Airedale, Wharfedale & Craven:, Keighley

CB22 3GN

RECRUITING

Pillsorted Ltd, Cambridge

HU7 4PT

RECRUITING

Sutton Manor Pharma Services, Hull

RM1 2BA

RECRUITING

Barking, Havering and Redbridge University Hospitals NHS Trust, London

Sponsors
All Listed Sponsors
lead

Heartfelt Technologies

INDUSTRY

NCT06334822 - Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK. | Biotech Hunter | Biotech Hunter