Primary Objective:
• To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation.
Secondary Objective:
• To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group.

开始日期2024-03-30

申办/合作机构

Dosentrx Ltd.

NCT06335758 / RecruitingN/A

Non-randomized Observational Study to Collate Data Regarding the Safety, Efficacy and Satisfaction of ReX® in the Management of Solid Oral Medications.

The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.
The study will evaluate and monitor use of ReX in respect of:
treatment duration
adverse events
patient adherence and compliance
engagement with ReX via patient-reported outcomes
Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.

开始日期2024-01-15

申办/合作机构

Dosentrx Ltd.

[+1]

NCT04215796 / Unknown statusN/A

Evaluation of the Safety, Usability and Efficacy of the ReX-C® System in Medication Management, in Patients Receiving CFTR Modulators (Kalydeco, Orkambi and/or Symdeko) for the Treatment of Cystic Fibrosis (CF).

Cystic fibrosis (CF) is a progressive multisystem disorder characterized by abnormalities in the transport of chloride ions in human airway epithelial cells, leading to frequent lung infections, decreased pulmonary function, inability to properly digest food and absorb essential nutrients, and complications with many organs.
Patients with CF spend hours daily, in treatments required to manage their disease, including hours of physiotherapy and inhalation and treatment with many daily pills. CF treatment load heavy burden on patients and families and the inevitable consequence of these treatment demands is widespread non-adherence to therapy.
CFTR modulators (trade name Kalydeco, Orkambi, Simdeco) is a highly efficient drug approved to treat CF in patients with certain mutations. It is the first drug that treats the underlying cause rather than the symptoms of the disease. It is also one of the most expensive drugs, costing over $300,000 per patient per year. Despite of its proven efficacy and approved reimbursement for certain patients, non-adherence is common among CF patients, resulting from the heavy burden of daily treatment required to manage CF disease.

开始日期2020-05-12

申办/合作机构

Dosentrx Ltd.

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2021-05-04·Pain Research and Management3区 · 医学

Patient-Controlled Analgesia (PCA): Intravenous Administration (IV-PCA) versus Oral Administration (Oral-PCA) by Using a Novel Device (PCoA® Acute) for Hospitalized Patients with Acute Postoperative Pain—A Comparative Retrospective Study

3区 · 医学

ReviewOA

作者: Shtrichman, Ronit ; Wirz, Stefan ; Seidensticker, Stefanie

Background. Acute postoperative pain delays recovery and increases morbidity and mortality. Opioid therapy is effective but is accompanied by adverse reactions. Patient-controlled analgesia (PCA) enables self-administration of analgesics. Oral-PCA is a safe and beneficial alternative to intravenous (IV) PCA. We have developed a novel Oral-PCA device, which enables self-administration of solid pills to the patient’s mouth. This is a retrospective study comparing the effectiveness and usability of this novel Oral-PCA with those of IV-PCA. Methods. Medical records of patients who received PCA following gynecology and orthopedic surgeries were analyzed. The control cohort (n = 61) received oxycodone by IV-PCA. The test cohort (n = 44) received oxycodone by Oral-PCA via the PCoA Acute device. Outcome measures include the Numeric Rating Scale (NRS) score at rest and movement, side effects, technical difficulties, bolus dose administered, and bolus dose requested. Results. Patient demographics, initial NRS, and PCA duration were comparable between cohorts. NRS reduction in rest and movement was stronger in the Oral-PCA cohort (rest: 1.61 and 2.27,P = 0.077; movement: 2.05 and 2.84,P = 0.039), indicating better pain control and mobility for Oral-PCA. Side effect rates were comparable between cohorts (9% and 11% of patients who experienced side effects,P = 1.000). The rate of technological difficulties was higher in the Oral-PCoA cohort (19.7% and 36.4%,P = 0.056). The mean total bolus dose administered to patients was comparable in both cohorts (18.32 mg and 21.14 mg oxycodone,P = 0.270). However, the mean total boluses requested by patients during lockout intervals were lower in the Oral-PCA cohort (12.8 mg and 6.82 mg oxycodone,P = 0.004), indicating better pain control. Conclusions. Oral-PCA by using PCoA® Acute provides pain control and usability which is noninferior to the IV-PCA, as well as superior to pain reduction in rest and movement. These results, along with the noninvasiveness, medication flexibility, and reduced cost, suggest the potential of Oral-PCA, by using PCoA Acute, to replace IV-PCA for postoperative analgesia.

2017-01-01·Pain Research and Management3区 · 医学

Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, thePCoA® AcuteDevice, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study

3区 · 医学

ArticleOA

作者: Shtrichman, Ronit ; Schimo, Kai ; Hoffmann, Eva ; Wirz, Stefan ; Conrad, Stefan

Background.Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute.Methods.A controlled pilot study was conducted at three medical centers. Patients scheduled for elective surgery were enrolled into two groups, both taking oral analgesics: a control group (n=43), opioids dispensed by nurses, and a test group (n=27), opioids dispensed via the PCoA Acute. Pill intake data were recorded. Pain ratings at rest and during movement were surveyed.Results.No severe adverse events were recorded. Average pill intake time was reduced from 8 : 58 minutes in the control group to 1 : 17 minutes in the test group (Pvalue < 0.05). The test group took 67% more pills than the control group, indicating enhanced compliance. Pain scores were significantly lower for patients in the test group (Pvalue < 0.05). Over 90% of PCoA Acute users were satisfied with its use.Conclusions.The study confirmed that PCoA Acute is safe and effective. It is well accepted by patients and medical staff. Its use can optimize pain medication administration.

JMIR Human Factors

Use of a Digital Medication Management System for Effective Assessment and Enhancement of Patient Adherence to Therapy (ReX): Feasibility Study

Article

作者: Epstein, Shirli ; Conrad, Stefan ; Machluf, Ehud ; Epstein, Howard ; Shtrichman, Ronit ; Schimo, Kai ; Paz, Alan ; Shachar, Ran ; Mindal, Enrique

BACKGROUNDMedication nonadherence is a major problem in health care, imposing poor clinical outcomes and a heavy financial burden on all stakeholders. Current methods of medication adherence assessment are severely limited: they are applied only periodically, do not relate to actual pill intake, and suffer from patient bias due to errors, misunderstanding, or intentional nonadherence. ReX is an innovative medication management system designed to address poor patient adherence and enhance patient engagement with their therapy. ReX controls and tracks pills from the point of packaging right through to the patient's mouth. ReX generates robust, real-time adherence data. The system enables patients to report outcomes, complete surveys, and receive messages and instructions. ReX includes a reusable drug dispensing unit, disposable cassette containing pills, and a cloud-based data portal.OBJECTIVEWe aimed to evaluate ReX feasibility by human factor studies including evaluation of ReX safety; ReX acceptance and usability; and ReX efficacy of providing pills according to a preprogrammed dose regimen, managing reminders and adherence data, and enhancing the adherence rate compared with the standard of care.METHODSThe ReX system was evaluated in 2 human factor, nonclinical feasibility studies. Human subjects used ReX for the administration of pill-shaped Tic Tac sweets. The initial study evaluated ReX use and pill intake administration; second was a self-controlled, 4-day home-use study. All subjects took pills at home, according to a preprogrammed dose regimen, for 4 days each via the device (ReX test) or from standard packaging (control test). The adherence rate (percent of pills taken) was measured by the study subject's report, remaining pills count, and ReX records (in the ReX test). ReX safety and usability were evaluated by a questionnaire filled out by the subject.RESULTSThe initial feasibility study evaluated usability and acceptance of the ReX novel approach to pill dispensing. All subjects successfully managed 2 pill intakes. The ReX device was rated as easy to use by 81% (48/59) of subjects. The 4-day home-use study evaluated the safety, efficacy, and usability of the ReX system. No adverse event occurred; no pill overdose or pill malformation was reported. The overall adherence rate in the ReX test was 97.6% compared with 76.3% in the control test (P<.001). Real-time, personalized reminders provided in the event of a delay in pill intake contributed to 18.0% of doses taken during the ReX test. The ReX system was found easy to use by 87% (35/40) of subjects; 90% (36/40) felt comfortable using it for their medication.CONCLUSIONSReX's novel "tracking to the mouth" technology was found usable and accepted by subjects. The assessment of adherence rates was reliable; adherence of subjects to the dose regimen was significantly enhanced when using ReX compared with the standard of care.

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