Digital Care Programs for Female Pelvic Health

Digital Care Programs for Female Pelvic Health: a Large-scale, Multi-disorder, Observational Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pelvic Organ Prolapse; Pelvic Pain; Pelvic Floor Disorders; Pelvic Floor Muscle Weakness; Pelvic Pain Syndrome
• Intervention / Treatment: Device: Bloom Pod

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

• Study Type: Observational
• Enrollment (Anticipated): 50000

Contacts and Locations

Study Locations

• United States
  • Utah
    • Draper, Utah, United States, 84020
      • SWORD HEALTH INC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; These programs will cover participants with pelvic floor conditions which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these conditions.	Device: Bloom Pod; Pelvic floor program consisting of exercise performed while using the device, education and behavioural change

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported symptom level	Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale referring to the previous 7 days. Higher scores mean more symptoms.	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
Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)	The PFIQ-7 consists of 7 questions that need to be answered 3 times each considering symptoms related to the bladder or urine, vagina or pelvis, and bowel or rectum and their effect on function, social health, and mental health in the past 3 months. The responses for each question range from "not at all" (0) to "quite a bit" (3). To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.	Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Change over time common to all conditions measured through General Anxiety Disorder-7 (GAD-7) is a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Depression	Change over time common to all conditions measured through Patient Health Questionnaire-9 (PHQ-9), a 9-item scale (0-27). Higher scores mean higher depression levels.	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Work productivity and absenteeism	Change over time common to all conditions measured through Work Productivity and Activity Impairment Questionnaire (WPAI) assessed by the sub-scores: WPAI overall (combining presenteeism and absenteeism), WPAI work (presenteeism), WPAI time (absenteeism) and WPAI activities (activities of daily living impairment) (scores 0-100%). Higher scores mean greater impairment.	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported consumption of painkillers	Change over time common to all conditions measured through Self-reported consumption of painkillers (yes/no); Prescription drugs (yes/no); Opioids (yes/no)	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported intent to seek additional healthcare services	Change over time common to all conditions measured through a numerical rating scale (0-100). Higher scores mean higher intent.	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported fatigue (VAS)	Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean higher fatigue.	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Self-reported symptom level (VAS)	Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean more symptoms.	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sessions performed	Number of total exercise sessions performed	Measured at the end of the program, an average of 10 weeks
Self-reported satisfaction	measured through the Net Promoter Score question collected at end of program: "On a scale from 0 to 10, how likely are you to recommend SWORD's programs to a friend or family member?")	aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Total treatment time	Number of minutes spent on exercise sessions (aggregated)	Measured at the end of the program, an average of 10 weeks
Average treatment time per week	Average number of minutes spent on exercise per week	Measured at the end of the program, an average of 10 weeks

Collaborators and Investigators

• Sponsor: Sword Health, SA
• Investigators: Principal Investigator: Fernando Correia, PhD, SWORD Health, Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Anticipated): August 1, 2032
• Study Completion (Anticipated): December 1, 2032

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Pregnancy Complications; Muscle Weakness; Prolapse; Pelvic Organ Prolapse; Pelvic Floor Disorders; Pelvic Pain
• Other Study ID Numbers: BL-OBS-PH-US-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No