Digital Care Programs for Musculoskeletal Health: a Large-scale, Multi-disorder, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300,000
- 试验地点
- 1
- 主要终点
- Short form of Foot and Ankle Ability Measure (QuickFAAM)
研究概览
简要总结
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).
详细描述
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:
- 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;
- Correlate the results with patient's demographic and clinical profiles;
- Examine the impact of mental health and the behavioral modification components of SWORD Health interventions on disease markers, comorbidities, and productivity;
- 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
Clinical outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Short form of Foot and Ankle Ability Measure (QuickFAAM)
时间窗: 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
Change in condition-specific clinical outcomes over time, measured through the short form of Foot and Ankle Ability Measure (QuickFAAM). This is a 12-item scale with 5-likert options, the total number of points are added, divided by the total number os possible points and then multiplied by 100.
Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire
时间窗: 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
Change in condition-specific clinical outcomes over time measured through the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). Scoring Formula = (\[(sum of n responses)/n\] -1)x(25).
Short form Knee Osteoarthritis Outcomes score (KOOS-PS)
时间窗: 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
Change in condition-specific clinical outcomes over time, measured through the short form Knee Osteoarthritis Outcomes score (KOOS-PS) This is a 7-item scale with 5-likert options, the total number of points are added, divided by the total number os possible points and then multiplied by 100.
Neck Disability Index (NDI)
时间窗: 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
Change in condition-specific clinical outcomes over time measured through the Neck Disability Index (NDI). For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated as follows: Example:16 (total scored) 50 (total possible score) x 100 = 32%
Self-reported Pain (NPRS)
时间窗: 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
Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale
Short form Hip Osteoarthritis Outcomes Score (HOOS-PS)
时间窗: 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
Change in condition-specific clinical outcomes over time, measured through the short form Hip Osteoarthritis Outcomes Score (HOOS-PS). This is a 5-item scale with 5-likert options, the total number of points are added, divided by the total number os possible points and then multiplied by 100.
Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM)
时间窗: 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
Change in condition-specific clinical outcomes over time measured through Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM) (flexion/extension/abduction/rotation), in degrees, as directly retrieved from the angle measurement tool integrated within the medical device.
Oswestry Disability Index (ODI)
时间窗: 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
Change in condition-specific clinical outcomes over time measured through the Oswestry Disability Index (ODI). \\ The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Fear avoidance behaviour
时间窗: 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
Change over time in clinical outcomes of low back pain measured through the Fear Avoidance Beliefs Questionnaire - Physical Activity (FABQ - PA). This is a 5-item scale with 6 likert options. The total number of points are added. Maximum score is 30. Higher scores mean higher fear avoidance (higher scores are worse).
次要结局
- Self-reported Pain (VAS)(Baseline and following each exercise session through program completion, an average of 40 sessions)
- Self-reported fatigue (VAS)(Baseline and following each exercise session until the end of the program)
- Anxiety(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)
- Work productivity and absenteeism(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)
- Self-reported Surgical intent(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)
- Self-reported consumption of painkillers(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)
- Depression(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)