Идёт набор NCT06270771

OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study

— Наблюдательное MDS Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms RARS-T

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: OURA Ring.
Кому может быть актуально: Состояния в реестре: MDS, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, RARS-T. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months.

Подробное описание

This is a single-centre feasibility study involving two groups of patients (transfusion-dependent MDS and non-transfusion dependent MDS), each enrolling 30 patients. Eligible patients who consent to the study will be provided with the OURA ring sizing kit to determine their ring size. Baseline characteristics will be collected, including the following information if available:

* Patient demographics such as age, sex, history of cancer * MDS disease characteristics: date of diagnosis, IPSS and IPSS-R score, transfusion status, transfusion schedule, MDS specific treatment and concomittent medications * Laboratory data: hemoglobin, MCV, RDW, WBC, reticulocyte count, creatinine clearance, bilirubin, ALT, AST, LDH, ferritin

The correctly sized OURA ring will be ordered and provided to the patient within 4 weeks during their Baseline visit at "week 0". At this time, technological assistance will be provided for correctly wearing the ring, installation of the OURA app to their smartphone, and teaching the patient how to sync the OURA ring to their device. During this visit, patients will have their first clinical assessment which includes a physical exam, vitals, height and weight, as well as the 4-metre walk test and the administration of the study questionnaires (ECOG score, clinical frailty score, QLQ-C30, QUALMS, EQ-5D, global fatigue scale, and the Lawton-Brody instrumental activity of daily living (IADL) scale.

Patients will be given study forms to take home and complete based on the schedule listed in Appendix A. This includes a daily log of their global fatigue score, and a section for descriptive annotation of significant events in the day. Once every 7 days, patients will fill in the QLQ-C30, PROMIS-fatigue, QUALMS physical functioning subscale and synchronize the OURA ring data onto their smartphone.

Patients will have monthly follow-up appointments at 1 and 2 months into the study. At these times, clinical events in the month will be reviewed, including whether they had transfusions, hospitalizations, or major health events. Patients' OURA ring data will be reviewed. Depending on OURA ring results, the physician involved may determine to order additional investigations or referrals (such as sleep clinic assessment or cardiology referrals).

At month 3, patients will have their study exit visit. Data from the OURA ring app will be downloaded and a debrief will occur to qualitatively gauge the experience of a wearable device.

Вмешательства

Устройство OURA Ring
The OURA ring (https://ouraring.com) is a light-weight wearable device in the form of a ring that has several microsensors enabling detection of heart rate, blood oxygen level, skin temperature, and movement. The OURA ring and application can synthesize the sensory data to generate physiologic information such as sleep, activity level, resting heart rate, heart rate variability, respiratory rate, and more. The OURA ring is water resistant and has up to 5-7 days of battery life and can be fully c

Первичные конечные точки

Feasibility of patients with MDS wearing the OURA ring [Срок оценки: 3 months]

Вторичные конечные точки (1)

Exploratory correlations between physiologic changes captured by the wearable device and physical functioning [Срок оценки: 2 years]

Критерии участия

Критерии включения

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18 or older
Able to read, write and speak English or French (non-English or French speaking patients may participate if appropriate translation is used)
Diagnosed with Myelodysplastic Syndrome using WHO 2022 criteria (12) all risk groups
Ability to wear the OURA ring and operate the associated smart-phone app, and willing to adhere to the study regimen