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Clinical Trials/NCT03013192
NCT03013192TerminatedNot Applicable

Effect of a Three Month Automated Messaging Intervention on Patient Compliance to Physical Therapy Regimens and on Clinical Outcomes

St. Louis University2 sites in 1 country13 target enrollmentStarted: September 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
13
Locations
2
Primary Endpoint
Compliance with PT

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Arms & Interventions

Control

No Intervention

No text message reminders, usual patient protocol

Intervention (text messaging)

Experimental

Text message reminders for PT

Intervention: Text message reminder (Other)

Outcomes

Primary Outcomes

Compliance with PT

Time Frame: 3 months

Secondary Outcomes

  • American Shoulder And Elbow Surgeons Score(3 months)
  • Shoulder range of motion(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Scott Kaar, MD

Associate Professor

St. Louis University

Study Sites (2)

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