Three Month Automated Messaging Intervention
Primary Purpose
Rotator Cuff Tendinopathy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message reminder
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tendinopathy
Eligibility Criteria
Inclusion Criteria:
- Anterior or lateral shoulder tenderness
- Positive clinical signs of rotator cuff impingement
- X-ray with no fractures, glenohumeral arthritis, or dislocation
- Prescribed shoulder PT for their shoulder
Exclusion Criteria:
- None
Sites / Locations
- Saint Louis University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention (text messaging)
Arm Description
No text message reminders, usual patient protocol
Text message reminders for PT
Outcomes
Primary Outcome Measures
Compliance with PT
Secondary Outcome Measures
American Shoulder And Elbow Surgeons Score
Shoulder range of motion
Full Information
NCT ID
NCT03013192
First Posted
January 4, 2017
Last Updated
September 11, 2019
Sponsor
St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT03013192
Brief Title
Three Month Automated Messaging Intervention
Official Title
Effect of a Three Month Automated Messaging Intervention on Patient Compliance to Physical Therapy Regimens and on Clinical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
IRB and institutional re-assessment
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients who are prescribed physical therapy exercises for their shoulder will have increased compliance to their PT exercises, an increased ASES score, and will have increased range of motion (or reach maximum range of motion earlier) at the end of the 3 month EpxPhysicalTherapy intervention.
Detailed Description
Patient compliance to their prescribed physical therapy (PT) exercises is reported to be 22-40% in various studies. Further, Vasey et al. found that about 8% of patients do not even schedule a follow up PT appointment after it is prescribed. Low adherence presents a problem since long term completion of prescribed home exercises has been correlated with improved health outcomes. Sluijs et al. found that low adherence to PT exercises can be primarily attributed to three factors: (1) the barriers patients perceive and encounter, (2) the lack of positive feedback, and (3) the degree of helplessness. An automated phone/texting system can help with these three points by increasing positive feedback, increasing compliance, and monitoring patient progress. The system can continually remind the patient that their end goal is possible, which will decrease their feeling of helplessness in their condition.
Provide an introduction and background information. Describe past experimental and/or clinical findings leading to the formulation of the study, if applicable. Investigator Initiated studies must cite references in the response provided or attach a bibliography. *?HELP?*
Patient compliance to their prescribed physical therapy (PT) exercises is reported to be 22-40% in various studies [1-4]. Further, Vasey et al. found that about 8% of patients do not even schedule a follow up PT appointment after it is prescribed [5]. Low adherence presents a problem since long term completion of prescribed home exercises has been correlated with improved health outcomes. Sluijs et al. found that low adherence to PT exercises can be primarily attributed to three factors: (1) the barriers patients perceive and encounter, (2) the lack of positive feedback, and (3) the degree of helplessness [2]. An automated phone/texting system can help with these three points by increasing positive feedback, increasing compliance, and monitoring patient progress. The system can continually remind the patient that their end goal is possible, which will decrease their feeling of helplessness in their condition.
The American Shoulder and Elbow Surgeons (ASES) created a survey form that evaluates the shoulder function of a patient. The survey is scored out of 100 points (100 being best possible shoulder function and 0 being worst possible shoulder function). The form can be filled out on an iPad online, and the score recorded by a member of the medical team. This screening form has been validated by numerous studies, and has been specifically validated for patients with non-operative rotator cuff pain/abnormalities (the population that this study is proposing to study).
Telemedicine shows promise in improving the outcomes of orthopedic interventions. Medication adherence and patient outcomes have been shown to improve in interventions that include reminders. Also, because the adoption of cell phones is nearly ubiquitous worldwide and the vast majority of cell phone users text message, a text-message-based intervention seems particularly promising.
Many studies have shown that SMS text messaging has increased treatment compliance. PT adherence to prescribed exercises seems to be limited by compliance, so Epharmix along with several orthopedic surgeons set out to develop an intervention. The result, EpxPhysicalTherapy (EpxPT), is an automated system that ensures that patients have both scheduled their physical therapy appointment and have performed their home exercises. It also sends motivational text messages to the patient to encourage the participant to perform their exercises since a lack of positive reinforcement has been correlated with decreased compliance. When a patient identifies that they have been unable to schedule a PT appointment or have not completed their exercises for multiple days in a row, an alert is sent to the healthcare team.
The system was designed to deliver either voice or text-based automated messages to patients in a way that avoids an additional burden on the healthcare team. EpxPT offers numerous advantages to strictly app-based or text message-based systems in both older and underprivileged patient populations. Older patients, who may be more comfortable with voice messages, have that option, and patients without a smartphone will still be able to receive the intervention.
Patients identified to be eligible for this study and have consented will be randomly assigned to one of two groups: Group 1 will receive the standard of care alone (control) and Group 2 will receive the EpxPT intervention. In Group 2, EpxPT will remind the patient to schedule their first PT appointment. Group 2 patients will also be asked if they have completed their prescribed PT exercises every other day. They will then be sent a motivational text messages or voice call in order to highlight the importance of completing their PT regimen. Group 2 patient compliance will be tracked through the text responses recorded in the Epharmix database. Both Group 1 and Group 2 patients will be seen at a follow up appointment once a month for three months. At this appointment, patients in both groups will be asked about their PT compliance (this will be the measurement of compliance for Group 1), and range of motion and a ASES score will be measured.
Aim 1: To compare control and intervention group compliance to their prescribed physical therapy home exercise regimen
Aim 2: To compare control and intervention group shoulder range of motion after a 3 month intervention
Aim 3: To compare control and intervention group ASES scores after a 3 month intervention
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No text message reminders, usual patient protocol
Arm Title
Intervention (text messaging)
Arm Type
Experimental
Arm Description
Text message reminders for PT
Intervention Type
Other
Intervention Name(s)
Text message reminder
Intervention Description
Patients will receive automated text message reminders regarding their physical therapy
Primary Outcome Measure Information:
Title
Compliance with PT
Time Frame
3 months
Secondary Outcome Measure Information:
Title
American Shoulder And Elbow Surgeons Score
Time Frame
3 months
Title
Shoulder range of motion
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anterior or lateral shoulder tenderness
Positive clinical signs of rotator cuff impingement
X-ray with no fractures, glenohumeral arthritis, or dislocation
Prescribed shoulder PT for their shoulder
Exclusion Criteria:
None
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Three Month Automated Messaging Intervention
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