We are conducting a research study that aims to develop digital patient-tracked measures for routine outcome monitoring (ROM) that can be used in clinical settings with patients with chronic pelvic pain disorders. There are currently no standard universal measures that can be used for monitoring treatment responses for this heterogenous cluster of conditions that include endometriosis, adenomyosis, uterine fibroids, among others.
Therefore, the purpose of study d2prom is to gather information from patients diagnosed with CPP and beginning physical therapy (PT) about their symptoms as they go through their PT treatment. The data will be used to identify factors that are most informative for deciding whether a treatment is working (e.g., Does physical therapy help reduce pain?). Then, we will use these to design and evaluate a digital ROM that captures the patient’s experience and can be used by PT providers to assess treatment effects and outcomes.
Do you have a clinician diagnosis for chronic pelvic pain disorder (e.g., endometriosis, uterine fibroids, adenomyosis)?
Have you been experiencing pelvic pain symptoms for 6 months or longer?
Are you between the ages of 18 and 64 years?
Are you starting physical therapy (PT) treatment with a physiotherapist for your pelvic pain symptoms?
If you responded “Yes” to these questions, and you are currently not undoing treatment for other major conditions (e.g., cancers, acute coronary syndromes), you might be eligible to participate in this 12-week study. If you are interested in participating and would like to check eligibility, you can access the study screener through the link (https://redcap.mountsinai.org/redcap/surveys/, Enter Code: NE9EYXXJE)
For this study, we are specifically looking for patients who are about to begin pelvic floor PT. If you are interested in participating in this study but have already had several PT sessions with your provider, our team is also conducting another similar study (CPP Tracker) you might want to consider. To learn more about CPP Tracker, visit https://www.hpims.org/research-projects/cpp-tracker/.
What does participation in this study involve?
If you choose to participate in the d2prom study, you will be asked to:
Download two research apps (freely available in App stores) on your smartphone
Wear an activity tracker (Fitbit Inspire 3) provided by the study team every day for 12 weeks
Meet with our research coordinator (virtually) upon enrollment for them to orient you to the mHealth Apps and the activity tracker for the study. This orientation meeting takes about 40 minutes, and you will have the chance to ask our coordinator any questions you might have.
Self-track your daily symptoms, well-being, self-management techniques, and brief details about your physical therapy (PT) exercises
Complete brief standardized questionnaires on pain and quality of life each week through the ehive app
We are recruiting from multiple collaborating PT Centers in New York City area for this study:
Fiona McMahon, PT, DPT (New Jersey)
Mount Sinai West (425 West 59th Street, 3rd floor)
We will be adding more collaborating PT Centers to our list in the coming months.
The overall goal of d2prom is to develop treatment outcome monitoring measures that are reflective of patient’s experience and can be used in clinical settings by providers. This can have important implications such as making it easier to obtain health insurance coverage of PT treatments and improving the assessment of patient’s progress throughout the treatment.
This research study is conducted by researchers at the Icahn School of Medicine at Mount Sinai and Columbia University in NYC (Principal Investigator: Ipek Ensari, PhD) and is funded by the National Institutes of Health (Grant #: R01HD108263).
For questions regarding study participation, you can reach out to our study team at email@example.com.