Clinical trial NCT05417685: Digital Care Programs for Musculoskeletal Health
Official title: Digital Care Programs for Musculoskeletal Health: a Large-scale, Multi-disorder, Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Musculoskeletal Diseases
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 300000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: These programs will cover patients suffering from musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which, irrespective of their duration (acute, post-acute or chronic), significantly impact their quality of life, to the extent they seek specialized care in direct relation to these disorders. The programs will also cover patients submitted to surgery for a given musculoskeletal condition, including, but not limited to, shoulder tendon repair, shoulder replacement, spinal surgery, hip or knee replacement, meniscal repair, knee ligament reconstruction, undergoing physical rehabilitation programs after surgery.

Brief summary: The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for musculoskeletal conditions and musculoskeletal health delivered by SWORD Health 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 musculoskeletal disorders (MSD).

Detailed description: This scientific research was designed to:

* Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health
* Assess the results of digital care programs and compare the costs with the benefits obtained;
* Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
* Develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health

Collection and objective analysis of the collected data will allow:

1. Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal 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 SWORD Health interventions on disease markers, comorbidities, and productivity;
5. Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
6. Develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health

Clinical outcomes

The primary outcome will be the evolution of patient's clinical condition along the rehabilitation program, objectively estimated through the monitoring data collected using SWORD Phoenix®, as part of patients' supervision routine. Depending on the condition, primary and secondary outcome measures vary.

In any case, this registry will include a complete characterisation of the clinical condition, as well as the periodic assessment of: a) joints' range of motion (collect by the medical device); b) performance indicators (through condition-specific tests); c) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); d) pain and fatigue levels (reported by patients by the end of each therapeutic exercise session); e) compliance; f) patient satisfaction

Eligibility criteria: Inclusion Criteria:

* Over 18 years old;
* Acute (\<12 weeks) or chronic (\>12 weeks) musculoskeletal pain involving any of the following body areas: neck, upper and lower back, shoulder, elbow, wrist/hand, hip, knee, ankle OR Recovering from MSK surgery involving the above body areas with indication from their surgeon to engage in a 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
* Rapidly progressive and new in onset neurological complaints if not cleared by a physician to engage in an exercise program
* Active cancer diagnosis or receiving treatment for cancer if not cleared by a physician to engage in an exercise program
* 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
* MSK surgery within the last 12 weeks and not cleared by a physician to engage in an exercise program

Primary outcomes:
measure: Self-reported Pain (NPRS)
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Neck Disability Index (NDI)
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Short form of Foot and Ankle Ability Measure (QuickFAAM)
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Short form Hip Osteoarthritis Outcomes Score (HOOS-PS)
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Short form Knee Osteoarthritis Outcomes score (KOOS-PS)
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Fear avoidance behaviour
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM)
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Secondary outcomes:
measure: Self-reported Pain (VAS)
timeFrame: Baseline and following each exercise session through program completion, an average of 40 sessions
measure: Self-reported fatigue (VAS)
timeFrame: Baseline and following each exercise session until the end of the program
measure: Self-reported Surgical intent
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Self-reported consumption of painkillers
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Anxiety
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Depression
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Work productivity and absenteeism
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Other outcomes:
measure: Sessions performed
timeFrame: Measured at the end of the program, an average of 12 weeks
measure: Self-reported satisfaction
timeFrame: Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Total treatment time
timeFrame: Measured at the end of the program, an average of 12 weeks
measure: Average treatment time per week
timeFrame: Measured at the end of the program, an average of 12 weeks
Locations:
city: Draper
country: United States
facility: Sword Health
state: Utah
Study officials:
affiliation: SWORD HEALTH INC
name: Fernando D Correia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: