Clinical trial NCT06733480: Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue
Official title: Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Anatomic Total Shoulder Arthroplasty
Reverse Total Shoulder Arthroplasty
Keywords: physical therapy compliance
home-based physical therapy
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Band Connect
First posted: 2024-12-13
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants are being invited to take part in this research study because you will be undergoing total shoulder replacement or rotator cuff repair and will be participating in physical therapy rehabilitation following the procedure. The purpose of this research is to investigate the effectiveness of Band Connect, a connected health platform, in enhancing compliance with home exercise programs among patients undergoing physical therapy. This study aims to evaluate the implications of increased compliance on improving patient engagement and increasing satisfaction for both patients and clinicians. Additionally, the study will analyze the economic implications of implementing Band Connect's hybrid care model on driving increased revenue per patient.


Eligibility criteria: Inclusion Criteria:

* Age range: from 18 to 89 years old
* Surgery performed by Dr. Robert Gillespie and will be undergoing post-op physical therapy rehabilitation at University Hospitals
* Patients undergoing primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA)
* Patients undergoing primary rotator cuff repair
* Prescribed outpatient physical therapy for post-operative rehabilitation

Chart Review Inclusion Criteria:

* Age range: from 18 to 89 years old
* Surgery performed by Dr. Robert Gillespie who underwent post-op physical therapy rehabilitation at University Hospitals
* Patients who underwent primary anatomic total shoulder shoulder arthroplasty (aTSA) or primary reverse total shoulder arthroplasty (rTSA)
* Patients who underwent primary rotator cuff repair
* Prescribed outpatient physical therapy for post-operative rehabilitation

Exclusion Criteria:

* Patients undergoing hemiarthroplasty or revision TSA
* Patients undergoing revision rotator cuff repair
* TSA performed for proximal humerus fractures
* Length of stay in hospital following shoulder surgery greater than 3 days
* Shoulder injuries related to workers compensation or involved in any pending litigation
* Pregnant individuals

Chart Review Exclusion Criteria:

* Patients undergoing hemiarthroplasty or revision TSA
* Patients undergoing revision rotator cuff repair
* TSA performed for proximal humerus fractures
* Length of stay in hospital following shoulder surgery greater than 3 days
* Shoulder injuries related to workers compensation or involved in any pending litigation
* Pregnant individuals

Primary outcomes:
measure: Number of physical therapy visits as measured by medical record review.
timeFrame: Up to 6 months
measure: Number of home exercise programs completed as measured by medical record review.
timeFrame: Up to 6 months
measure: Number of in clinic visits as measured by medical record review.
timeFrame: Up to 6 months
measure: Number of patients who were able to return to work
timeFrame: Up to 6 months
measure: Time to return to work measured in weeks
timeFrame: Up to 6 months
measure: Number of patients who returned to sports
timeFrame: Up to 6 months
measure: Change in pain as measured by the Visual Analog Scale
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Active range of motion measured in degrees
timeFrame: Up to 6 months
measure: Passive range of motion measured in degrees
timeFrame: Up to 6 months
measure: Strength will be measured on a scale of 0-5
timeFrame: Up to 6 months
measure: Patient satisfaction as measured by American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: Up to 6 months
measure: Number of adverse events as measured by medical record review.
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Robert Gillespie
role: PRINCIPAL_INVESTIGATOR
References: