Real-Life Pilot Feasibility Study (LC_RLP)

Summary

The LifeChamps Real-Life pilot's objective is to ascertain the feasibility of the use of the LifeChamps solution, previously developed in another clinical trial, in a real-world environment. This solution integrates a health advisory system, and technical intelligence, based on behavioural science, to provide personalized recommendations to follow a healthier lifestyle, to act as a nutrition and physical activity coach, and to guide on social inclusion, among other issues, with the aim of increasing the quality of life. This study is conducted to investigate the feasibility of such an undertaking, assess the clinical impact it may have, as well as evaluate the applicability, usability, and effectiveness of the solution.

Conditions

• Breast Cancer
• Prostate Cancer

Interventions

DEVICE

LifeChamps Platform HCP

Healthcare professionals that will participate in the study will be introduced will have access to the LifeChamps Dashboard, which will display the data monitored from the patients, thus potentially facilitating patients' follow-up between clinical consultations. The LC Dashboard will provide pseudonymised information regarding the patients' physical activity and PROMs for the purpose of the pilot feasibility trial. They will not be able to view real time processed information, such as risk of frailty, QoL, risk of dependency and psychological condition, from the LIFECHAMPS analytics engine. They will be shown the anonymised outputs of the engine per patient and asked their opinions on the usability, acceptability and on whether such information would have helped better manage their patients' supportive care.

DEVICE

LifeChamps Platform

Participants will be asked to provide 5 endpoints (PROMS) and will be provided with the study equipment, i.e., a mobile app, smartwatch, smart scale, location home sensor, a smart plug, and a micro-computer, with which they will need to interact with the devices for three months. Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) as much as possible. Additionally, participants should use the smart scale to weigh themselves and the mobile app to fill in selected PROMs monthly, while the ambient home sensors will be passively collecting information about their everyday living during these three months. At the end of the 3 month period, the participants will return the devices and will be asked to provide the 5 endpoints and their opinions regarding the usability and acceptability of the platform using structured questionnaires

Sponsors & Collaborators

• University of Glasgow

  collaborator OTHER

• Region Stockholm

  collaborator OTHER_GOV

• Hospital Universitario La Fe

  collaborator OTHER

• Aristotle University Of Thessaloniki

  lead OTHER

Principal Investigators

• Panos D Bamidis, PhD · Aristotle University Of Thessaloniki

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-15

Primary Completion

2023-11-30

Completion

2023-12-06

Countries

• Greece

Study Locations