Clinical trial · Interventional
Remote Electronic Patient Monitoring in Oncology Patients
NCT04086251CI-TRIAL-00040528unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gaido | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gaido Intervention
- description
- 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.
- interventionNames
- Other: Gaido
Primary outcomes (1)
- measure
- Feasibility of Gaido intervention for use by cancer patients
- timeFrame
- Evaluation last for 3 days after each patient use
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult oncology patients over the age of 18 who are receiving chemotherapy. 2. Adult oncology in-patients over the age of 18 who are being being discharged. 3. 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. 4. Patients who speak, read, and understand English. 5. Patients who have access to a smart phone. Exclusion Criteria: 1. Non-English speaking patients. 2. Pregnant women. 3. Tattoos on outer side of upper arm (where the heart rate device will be worn). 4. Infant or pediatric (age less than 18). 5. Dementia, unless accompanied by a full-time caregiver. 6. Physically unable to wear the associated wearable devices; for example, amputees (preventing the placement of wearable devices worn on the arm). 7. 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. 8. Body mass index (BMI) \>35 kg/m2, with conical shaped upper arms with significant adipose tissue (BP measurements might not perform properly). 9. Hospice patients who have an 'advanced directive'.
References
Publications (0)
Data not yet available
No reference posted for this study.