Sword Health Inc
Draper, Utah, 84020, United States
NCT Number: NCT05513417
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.
Interested in participating?
Request Info18 year–99 year
Female
Observational
Draper, Utah, 84020, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pelvic floor program consisting of exercise performed while using the device, education and behavioural change
Time frame: 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
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.
Time frame: Baseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
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.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
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.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
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.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
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.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Change over time common to all conditions measured through Self-reported consumption of painkillers (yes/no); Prescription drugs (yes/no); Opioids (yes/no)
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Change over time common to all conditions measured through a numerical rating scale (0-100). Higher scores mean higher intent.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean higher fatigue.
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
Change over time common to all conditions measured through a 0-10 Visual Analogue Scale. Higher scores mean more symptoms.
Time frame: Measured at the end of the program, an average of 10 weeks
Number of total exercise sessions performed
Time frame: aseline, then 3, 5 and 10 weeks after program initiation, and then at 6, 12 and 24 months after enrolment
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?")
Time frame: Measured at the end of the program, an average of 10 weeks
Number of minutes spent on exercise sessions (aggregated)
Time frame: Measured at the end of the program, an average of 10 weeks
Average number of minutes spent on exercise per week
Sword Health, SA
Industry
Digital Care Programs for Female Pelvic Health: a Large-scale, Multi-disorder, Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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