Three Month Automated Messaging Intervention

September 11, 2019 updated by: Scott Kaar, MD, St. Louis University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
No text message reminders, usual patient protocol
Experimental: Intervention (text messaging)
Text message reminders for PT
Other: Text message reminder
Patients will receive automated text message reminders regarding their physical therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Compliance with PT
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
American Shoulder And Elbow Surgeons Score
Time Frame: 3 months
3 months
Shoulder range of motion
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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