Digital Care Programs for Female Pelvic Health

Status Enrolling by invitation

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05513417
Study type	Observational [Patient Registry]
Source	Sword Health, SA
Contact
Status	Enrolling by invitation
Phase
Start date	August 29, 2022
Completion date	December 2032

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.