OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study
- Conditions
- MDSMyelodysplastic Syndromes
- Interventions
- Device: OURA Ring
- Registration Number
- NCT06270771
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
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.
- Detailed Description
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, treatment details
* 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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)
- Able to provide informed consent
- Diagnosed with Myelodysplastic Syndrome using WHO 2022 criteria (12)
- Ability to wear the OURA ring and operate the associated smart-phone app, and willing to adhere to the study regimen
- Willing to operate and charge a smart phone loaded with the OURA ring app
- Performance status ECOG > 3.
- Cognitive or physical impairment preventing the usage or utilization of the OURA ring and smart phone.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Transfusion Dependent OURA Ring Patients who are currently receiving transfusions will be assigned to this cohort Transfusion Independent OURA Ring Patients who are not currently receiving transfusions will be assigned to this cohort
- Primary Outcome Measures
Name Time Method Feasibility of patients with MDS wearing the OURA ring 3 months Feasibility will be defined as being worn 70% of the time and uploaded to a web-based database weekly x 3 months.
- Secondary Outcome Measures
Name Time Method Exploratory correlations between physiologic changes captured by the wearable device and physical functioning 2.5 years Correlation between self-rated fatigue, physical functioning with steps taken, calories burned/day, sleep, readiness scores; Correlation between resting heart rate, heart rate variability, respiratory rate, oxygen saturation with hemoglobin, transfusion dependence, dates of transfusion, and unplanned healthcare encounters
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Research Centre
🇨🇦Toronto, Ontario, Canada