Clinical trial NCT05513417: Digital Care Programs for Female Pelvic Health
Official title: Digital Care Programs for Female Pelvic Health: a Large-scale, Multi-disorder, Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pelvic Floor Disorders
Pelvic Pain
Pelvic Organ Prolapse
Pelvic Floor Muscle Weakness
Pelvic Pain Syndrome
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 50000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These programs will cover patients suffering from pain and/or activity limitations in relation to the pelvic musculoskeletal systems, including but not limited to, pain/limitations affecting neuromusculoskeletal, genitourinary, gastrointestinal, and reproductive systems in this region. The programs will also cover patients submitted to surgery for a given pelvic condition involving any of the aforementioned systems.

Brief summary: The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.

This will allow the investigators to observe the acceptance, engagement and outcomes of programs using this approach in the treatment of multiple pelvic health disorders.

Detailed description: This patient registry was designed as a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.

This data will allow the researchers to:

1. Assess the adoption, engagement and feasibility of digital care programs for pelvic musculoskeletal disorders and pelvic health;
2. Assess the results of digital care programs and compare the costs with the benefits obtained;
3. Correlate the results with patient's demographic and clinical profiles;
4. Examine the impact of mental health and the behavioral modification components of Bloom's interventions on disease markers, comorbidities, and productivity;
5. Increase the knowledge on several pelvic musculoskeletal disorders, namely how they progress and respond to digital care programs;
6. Develop new or improved tools to assist clinicians in the management of these disorders and in helping people achieve better pelvic health

The primary outcome will be the evolution of the participant's condition along the program. Depending on the condition, primary and secondary outcome measures vary, but the registry will include, in all cases, a complete characterisation of the participant's pelvic health status, as well as the periodic assessment of: a) performance indicators (through condition-specific tests); b) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); c) pain levels; d) compliance; e) patient satisfaction

Eligibility criteria: Inclusion Criteria:

* Over 18 years old;
* Signs/symptoms consistent with an acute (\<12 weeks) or chronic (\>12 weeks) abdominopelvic condition without signs/symptoms indicating underlying disease states that require immediate referral for medical management OR recovering from pelvic surgery with indication from their surgeon to engage in a pelvic physical therapy program
* Able to understand study procedures and willing to provide informed consent.

Exclusion Criteria:

* Health condition (cardiac, respiratory, neurological, immune) condition incompatible with at least 20 minutes of light to moderate exercise if not cleared by a physician to engage in an exercise program
* Bone fractures or other musculoskeletal conditions in which mobilization of the segment or joint is contra-indicated
* Rapidly progressive and new in onset neurological complaints if not cleared by a physician to engage in an exercise program; or signs of acute, serious neurologic compromise
* Active cancer diagnosis or receiving treatment for cancer if not cleared by a physician to engage in an exercise program
* Signs/symptoms consistent with inflammatory bowel diseases (Crohn's, ulcerative colitis, etc.)
* Signs/symptoms consistent with an active pelvic infection
* Aphasia, dementia or any other psychiatric comorbidity that interferes with the use of the medical device
* Complicated or high-risk pregnancy
* Hemodynamic instability
* Significant trauma to the area of pain within the last 12 weeks and functional incapacity and not cleared by a physician to engage in an exercise program
* Surgery within the last 12 weeks and not cleared by a physician to engage in an exercise program

Primary outcomes:
measure: Self-reported symptom level
timeFrame: Baseline, and then at regular intervals (after 9, 15 and 30 sessions) after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
timeFrame: Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Secondary outcomes:
measure: Anxiety
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Depression
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Work productivity and absenteeism
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Self-reported consumption of painkillers
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Self-reported intent to seek additional healthcare services
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Self-reported fatigue (VAS)
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Self-reported symptom level (VAS)
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Other outcomes:
measure: Sessions performed
timeFrame: Measured at the end of the program, an average of 10 weeks
measure: Self-reported satisfaction
timeFrame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
measure: Total treatment time
timeFrame: Measured at the end of the program, an average of 10 weeks
measure: Average treatment time per week
timeFrame: Measured at the end of the program, an average of 10 weeks
Locations:
city: Draper
country: United States
facility: Sword Health Inc
state: Utah
Study officials:
affiliation: Sword Health, Inc
name: Fernando Correia, PhD
role: PRINCIPAL_INVESTIGATOR
References: