Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06270771 |
| Other study ID # |
5823 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2024 |
| Est. completion date |
February 1, 2026 |
Study information
| Verified date |
November 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
