Digital Care Programs for Female Pelvic Health

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05513417
• Other study ID #: BL-OBS-PH-US-01
• Status: Enrolling by invitation
• Start date: August 29, 2022
• Est. completion date: December 2032

Study information

• Verified date: August 2022
• Source: Sword Health, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50000
• Est. completion date: December 2032
• Est. primary completion date: August 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Pelvic Floor Disorders
• Pelvic Floor Muscle Weakness
• Pelvic Organ Prolapse
• Pelvic Pain
• Pelvic Pain Syndrome
• Prolapse

Intervention

Device:
• Bloom Pod
Pelvic floor program consisting of exercise performed while using the device, education and behavioural change

Locations

Country	Name	City	State
United States	Sword Health Inc	Draper	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Sword Health, SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sessions performed	Number of total exercise sessions performed	Measured at the end of the program, an average of 10 weeks
Other	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
Other	Total treatment time	Number of minutes spent on exercise sessions (aggregated)	Measured at the end of the program, an average of 10 weeks
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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