Use of a Telematics Device for Daily Monitoring of Vital Signs in Home-care Patients With Advanced Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fondazione ANT Italia ONLUS
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of measurements
Study Overview
Brief 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.
Detailed Description
BACKGROUND
The overloading of healthcare facilities and the need to prevent the risk of infection during Covid-19 emergency have highlighted the need to implement significant changes in the organization and delivery of healthcare services, mainly when these are aimed at the most fragile segments of the population, as in the case of palliative care. In order to assist with an efficient program of home palliative care for an increasing number of patients, scientific evidence is progressively underlining the need to integrate telemedicine intervention into home care protocols. The introduction of telemonitoring systems in home palliative care aims to facilitate more effective patient care, reducing both emergency room and hospital admissions and improving symptoms of distress, anxiety, and depression in patients and caregivers. Self-monitoring also increases patients' awareness by making them feel part of their care pathway and active contributors to their well-being.
Telemonitoring mainly uses medical devices to record parameters relating to the patient's state of health or treatment progress. Once registered, the data are shared on a cloud platform and then viewed by the physician, who can intervene in real-time in the event of clinically significant anomalies reported by the system.
In the panorama of medical devices used for this purpose in Italy, there is ButterfLife® (VST Srl, Modena Italy), a medical device similar to a joypad, designed by the Unimore spinoff VST (Vital Signal in a Touch), which, thanks to special sensors, allows to measure simultaneously the five primary vital parameters defined by the WHO in 90 seconds (heart rate, respiratory rate, blood oxygenation, blood pressure and body temperature). To record these parameters, the patient has to place both hands on the device, and the data collected are immediately transmitted to a portal whose software (VST-FIVE) calculates the vital signs and allows visualization the sharing with the doctor via a Wi-Fi network. In this way, it is possible to ensure early detection of worsening and failure of the health state enabling a timely activation of appropriate intervention in the home setting. The recorded data remains available for subsequent evaluation, long-term monitoring, and offline analysis.
In the present study, the ANT Foundation proposes to evaluate the feasibility and outcomes of a daily monitoring model of five vital signs (heart rate, respiratory rate, blood oxygenation, blood pressure and body temperature) conducted through the ButterfLife medical device in cancer patients assisted at home with cardiovascular and respiratory comorbidities.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with advanced cancer assisted at home;
- •Age ≥ 18 years;
- •Able to understand the objectives of the study and sign the informed consent;
- •Able to speak and understand the Italian language;
- •KPS ≥ 50;
- •Presence of at least one of the following comorbidities:
- •Chronic Obstructive Pulmonary Disease (COPD);
- •Chronic ischaemic heart disease (CIC) after acute myocardial infarction (AMI)
- •Pulmonary emphysema;
- •Valvulopathy;
- •Systemic arterial hypertension;
- •Severe coronary artery disease;
- •Respiratory failure related to primary or metastatic lung cancer disease;
- •Cardiomyopathy developed after oncological treatment. This symptomatology may be directly related to the oncological disease or independent of it (pre-existing pathology at the time of cancer diagnosis, symptoms occurring as a result of oncological therapies, age-related onset).
- •The severity of these comorbidities must be relevant to the patient's clinical profile expressed in at least one of the following conditions:
- •Resting oxygen saturation level < 90% in room air or oxygen therapy.
- •Systolic/diastolic blood pressure greater than 140/90 mmHg or less than 90/60 mmHg, or on antihypertensive medication.
- •Resting heart rate greater than 100 or less than 60 beats per minute or being treated with anti-arrhythmic drugs, presence of a pacemaker.
Exclusion Criteria
- •Patients with a diagnosis of dementia or cognitive impairment hampering the comprehension of the study information and/or signing of informed consent,
- •Patients who are dying.
- •Patients refusing to participate.
Arms & Interventions
ButterfLife
The patient will be recommended to take the measurement of five vital parameters once a day by ButterfLife device. Daily telemonitoring will be conducted in addition to standard home care.
Intervention: ButterfLife (Device)
Control
The patients will receive standard home care.
Intervention: Control (Other)
Outcomes
Primary Outcomes
Number of measurements
Time Frame: 8 weeks
Number of measurements/week per patient.
Acceptability
Time Frame: 8 weeks
Percentage of eligible patients proposed for the study who agree to participate.
Secondary Outcomes
- Quality of life(Day 1, day 28 and day 56)
- Psychological status(Day 1, day 28 and day 56)
- Perceived health status(Day 1, day 28 and day 56)
- Caregiver burden(Day 1, day 28 and day 56)
- Satisfaction with care(Day 56)