CancerNCT04086251
Remote Electronic Patient Monitoring in Oncology Patients
A study testing Gaido in people with Cancer, run by Gaido Health at 1 site in United States.
Trial summary
The goal of this research is to study an intervention, which the investigators call "Remote Electronic Patient Monitoring," that entails vital sign data (enabled with smart algorithms for notification) and patient-reported outcomes (PROs), (such as physical and psychological symptoms) intended to address and manage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Gaido
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult oncology patients over the age of 18 who are receiving chemotherapy.
- Adult oncology in-patients over the age of 18 who are being being discharged.
- Patients who have the mental capacity to understand how to use the devices and phone App; or patients who have a 24-hour caregiver who can manage the devices and complete patient surveys.
- Patients who speak, read, and understand English.
- Patients who have access to a smart phone.
Who cannot join
- Non-English speaking patients.
- Pregnant women.
- Tattoos on outer side of upper arm (where the heart rate device will be worn).
- Infant or pediatric (age less than 18).
- Dementia, unless accompanied by a full-time caregiver.
- Physically unable to wear the associated wearable devices; for example, amputees (preventing the placement of wearable devices worn on the arm).
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- Existence of open wounds or skin breakdown in the designated area for wearable device placement or on patients with conditions of irritable skin, per clinician judgment based on patient assessment.
- Body mass index (BMI) >35 kg/m2, with conical shaped upper arms with significant adipose tissue (BP measurements might not perform properly).
- Hospice patients who have an 'advanced directive'.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research is to study an intervention, which the investigators call "Remote Electronic Patient Monitoring," that entails vital sign data (enabled with smart algorithms for notification) and patient-reported outcomes (PROs), (such as physical and psychological symptoms) intended to address and manage any concerning issues and or diagnoses identified.
Specifically, the plan is a study of oncology patients who will use the Gaido system for up to 21 days or per physician order.
Read the detailed description
Gaido Health's Remote Patient Monitoring Solution v1.0 is a wireless remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Every 15 minutes, a measurement is plotted on the User Interface of heart rate / respiration rate (by a Biovotion device). A non-invasive blood pressure (by an Omron device) along with an oral digital thermometer reading are taken per clinician orders and displayed on the Gaido dashboard. Wearable data are transmitted wirelessly from the Biovotion sensor (heart rate and respiratory rate) to the patient's smart phone that relays data to a cloud-based server for storage and analysis. Oral temperature and blood pressure are entered by the patient or care-giver into the patient's smart phone that relays data to a cloud-based server for storage.
The Remote Patient Monitoring system uses algorithms that indicate when patient vitals and patient reported outcomes have changed. Automatic patient surveys are sent to the patient with results displayed both on the computer located in the medical institution and the patient's smart phone. The patient surveys gather patient reported symptoms which are intended to be used in combination with vital signs to support decision-making. The system is intended for use with patients 18 years of age and older who are cared for by healthcare professionals.
- Conditions
- Cancer
- Being tested
- Gaido
- Keywords
- Neoplasm, Malignancy, Oncology, Remote patient monitoring
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaidoOther
Also called Remote electronic patient monitoring
Patients will participate for up to 21 days. Over the course of the study, 25-100 patients will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Gaido Intervention | Experimental | All patients enrolled in the study will participate in the Gaido Intervention, which entails wearing the Biovotion Everion continuously and take blood pressure and oral temperature spot checks per clinician orders. Patients will also be responsible for filling out PRO surveys and any surveys that trigger as a result of their vital signs falling outside of tailored thresholds. Receives: Other: Gaido |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Gaido intervention for use by cancer patients
Feasibility will be measured through utilization of the intervention to track statistics such as wear time, completion of patient reported outcomes patients who are meet the criteria and are enrolled in the study. o Analysis of patient wear time for Gaido, using reporting tools as part of the Gaido solution.
- Proportion of time that patients wear the Gaido solution
- Proportion of participants completing self-reported symptom monitoring through the device
- Proportion of participants completing vital sign data entry (blood pressure and oral temperature) through the device
Measured: Evaluation last for 3 days after each patient use
Secondary outcomes (2)
Acceptability of Gaido intervention for use by cancer patients
The research team will conduct semi-structured interviews with patients, to obtain feedback on usability and utility of the Gaido solution.
Measured: Evaluation last for 3 days after each patient use
Potential impact of Gaido intervention on cancer patient outcomes
To describe health care utilization, potential conditions detected on patients receiving Remote Electronic Patient Monitoring.corresponding interventions on patients receiving Remote Electronic Patient Monitoring.The Electronic Health Record (EHR) will be used to validate the potential Gaido conditions/findings. The following information will be gathered from the EHR: clinical factors (e.g. activities of daily living, tumor staging, diagnosis dates, cancer treatment, prior cancer history, medical comorbidities, and current medications), health care utilization (e.g. inpatient admissions and emergency department visits), and end-of-life care (e.g. death date, hospice enrollment, location of death).
Measured: Evaluation last for 3 days after each patient use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start9 Sep 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaido Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Guthrie Clinic
- Responsible party
- Sponsor
- Investigators
- Philip Lowry, MD, Principal investigator, Guthrie Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086251
- Sponsor's protocol ID
- GHBC-0719
- Status last verified
- Sep 2019
- First submitted
- 22 Jul 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Electronic Patient Monitoring in Oncology Patients
- ClinicalTrials.gov ID
- NCT04086251
- Acronym / sponsor ID
- GHBC-0719
- Conditions
- Cancer
- Keywords
- Neoplasm, Malignancy, Oncology, Remote patient monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gaido HealthIndustry (pharma, biotech, devices)
- Collaborators
- The Guthrie Clinic
- Study start
- 9 Sep 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to study an intervention, which the investigators call "Remote Electronic Patient Monitoring," that entails vital sign data (enabled with smart algorithms for notification) and patient-reported outcomes (PROs), (such as physical and psychological symptoms) intended to address and manage any concerning issues and or diagnoses identified.
Specifically, the plan is a study of oncology patients who will use the Gaido system for up to 21 days or per physician order.
Detailed description
Gaido Health's Remote Patient Monitoring Solution v1.0 is a wireless remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Every 15 minutes, a measurement is plotted on the User Interface of heart rate / respiration rate (by a Biovotion device). A non-invasive blood pressure (by an Omron device) along with an oral digital thermometer reading are taken per clinician orders and displayed on the Gaido dashboard. Wearable data are transmitted wirelessly from the Biovotion sensor (heart rate and respiratory rate) to the patient's smart phone that relays data to a cloud-based server for storage and analysis. Oral temperature and blood pressure are entered by the patient or care-giver into the patient's smart phone that relays data to a cloud-based server for storage.
The Remote Patient Monitoring system uses algorithms that indicate when patient vitals and patient reported outcomes have changed. Automatic patient surveys are sent to the patient with results displayed both on the computer located in the medical institution and the patient's smart phone. The patient surveys gather patient reported symptoms which are intended to be used in combination with vital signs to support decision-making. The system is intended for use with patients 18 years of age and older who are cared for by healthcare professionals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gaido Intervention | Experimental | Other: GaidoAll patients enrolled in the study will participate in the Gaido Intervention, which entails wearing the Biovotion Everion continuously and take blood pressure and oral temperature spot checks per clinician orders. Patients will also be responsible for filling out PRO surveys and any surveys that trigger as a result of their vital signs falling outside of tailored thresholds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult oncology patients over the age of 18 who are receiving chemotherapy.
- Adult oncology in-patients over the age of 18 who are being being discharged.
- Patients who have the mental capacity to understand how to use the devices and phone App; or patients who have a 24-hour caregiver who can manage the devices and complete patient surveys.
- Patients who speak, read, and understand English.
- Patients who have access to a smart phone.
Key exclusion criteria (9 listed)
- Non-English speaking patients.
- Pregnant women.
- Tattoos on outer side of upper arm (where the heart rate device will be worn).
- Infant or pediatric (age less than 18).
- Dementia, unless accompanied by a full-time caregiver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaidoAlso: Remote electronic patient monitoringPatients will participate for up to 21 days. Over the course of the study, 25-100 patients will be enrolled. | Other | Gaido Intervention |
Primary outcome
Feasibility of Gaido intervention for use by cancer patients
Time frame: Evaluation last for 3 days after each patient use
Feasibility will be measured through utilization of the intervention to track statistics such as wear time, completion of patient reported outcomes patients who are meet the criteria and are enrolled in the study. o Analysis of patient wear time for Gaido, using reporting tools as part of the Gaido solution. * Proportion of time that patients wear the Gaido solution * Proportion of participants completing self-reported symptom monitoring through the device * Proportion of participants completing vital sign data entry (blood pressure and oral temperature) through the device
2 secondary outcomes
Acceptability of Gaido intervention for use by cancer patients
Time frame: Evaluation last for 3 days after each patient use
Potential impact of Gaido intervention on cancer patient outcomes
Time frame: Evaluation last for 3 days after each patient use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Lowry, MD principal investigator
Guthrie Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaido in people with Cancer, run by Gaido Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Gaido intervention for use by cancer patients (time frame: Evaluation last for 3 days after each patient use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.