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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloom Pod | Device | Pelvic floor program consisting of exercise performed while using the device, education and behavioural change |
|
| 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 |
| 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 |
| 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?") |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Correia, PhD | Sword Health, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sword Health Inc | Draper | Utah | 84020 | United States |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D017699 | Pelvic Pain |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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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 |
| 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 |
| D052801 | Male Urogenital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |