Telematics Device for Daily Monitoring of Vital Signs in Cancer

Summary

The primary goal of this non-profit single-centre randomized pilot interventional study is to evaluate the acceptability of a daily telemonitoring of five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) using a medical device in advanced cancer patients with relevant cardiovascular and respiratory comorbidities assisted at home.

In addition to the standard home care, participants in the intervention group will keep the medical device at home. They will register five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) once a day for eight weeks. Participants belonging to the control group will receive standard home care.

The secondary goals of this study include the following:

* Analyzing the effect of telemonitoring on patients' quality of life and psychological status.
* Observing the possible effects of telemonitoring on the caregiver care burden.
* Assessing the possible effects of telemonitoring on the caregiver perceived satisfaction with the home care received.
* Comparing the number of physician and nurse home visits and phone calls between the patients using the device and patients in standard home care.
* Comparing the number of emergency room visits, admissions, and hospitalization days between the patients using the device and patients in standard home care.

Conditions

• Cancer
• Cardiovascular Diseases
• Respiratory Disease

Interventions

DEVICE

ButterfLife

On day 1, the investigator delivers the ButterfLife device at home and explains its use. The patient is recommended to take the measurement once a day, preferably in the morning and to repeat the measurement of parameters during the day if necessary. The doctor will check the data recorded by the patient every day and the trend of the parameters over time by a graphical representation on the electronic medical record (Vitaever®, Nethical S.r.l.). Daily telemonitoring will be conducted in addition to standard home care.

OTHER

Control

Patients will receive standard home care: visits will be planned according to the patient's needs. In case of an unstable clinical condition, worsening of symptoms, and alteration of vital parameters, patient can contact by phone the physician or the nurse, who will decide how to intervene.

Sponsors & Collaborators

• Vital Signals Touch srl (IppocraTech)

  collaborator UNKNOWN

• Nethical srl

  collaborator UNKNOWN

• Fondazione ANT Italia ONLUS

  lead OTHER

Principal Investigators

• Italo Malavasi · Fondazione ANT Italia ONLUS

• Guido Biasco · University of Bologna

• Anna Vittoria Mattioli · University of Modena e Reggio Emilia

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-23

Primary Completion

2023-11-23

Completion

2024-05-23

Countries

• Italy

Study Locations