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The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT

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ClinicalTrials.gov Identifier: NCT03035682
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Elson PT, Aultman Health Foundation

Brief Summary:
The purpose of this study is to determine the impact a mobile health application has on adherence to a physical therapy home exercise program and its effect on functional outcomes.

Condition or disease Intervention/treatment Phase
Orthopedic Disorder Musculoskeletal Injury Other: Augmented Media Group Other: Traditional Group Not Applicable

Detailed Description:
Outpatient physical therapy is an integral aspect in combating the impairment and dysfunction associated with musculoskeletal injuries. Healthcare and insurance restrictions are leading to reduced clinic visits, encouraging efficient and effective treatments and focusing a greater demand on education, proactive wellness and home exercise maintenance. Home exercise prescription has long been a fundamental aspect to a physical therapy routine or regimen. It is well established that exercise protocols can positively impact pain, fitness levels, physical function and measures of life quality (Forkan, Pumper, Smyth, Wirkkala, A Ciol, & Shumway-Cook, 2006). It is also recognized that treatment outcomes may be negatively impacted by non-adherence to the prescribed exercise recommendation in rehabilitation (Holden, Haywood, Portia, Gee, & Mclean, 2014). Research historically suggests that levels of non-adherence to exercise prescription range from 50-70% (Bassett, 2003; Sluijs, Kok, & van der Zee, 1993), and likely increase as time passes. Investigating non-adherence demonstrates a myriad of influencing factors. These factors can be characterized as motivators and barriers. With the explosion of mobile communications access and increasing number of active device users, healthcare is embarking on the concept of mobile health management. Mobile health interventions have been found to have a positive impact in the arenas of medication compliance, weight loss, chronic disease management and postoperative complication (Lee, 2016; Ronghua, Li, (2015).The implementation of a mobile health application in physical therapy outpatient management has not been well established. It is time to investigate the impact of using a mobile health application on a prescribed physical therapy treatment regimen for the enhancement of HEP adherence and functional outcome assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A Randomized Clinical Trial
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : July 23, 2018
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Traditional Group
The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription.
Other: Traditional Group
The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.

Experimental: Augmented Media Group
The Augmented Media group will receive traditional PT services as deemed clinically appropriate via examination and include home exercise prescription via a mobile health application.
Other: Augmented Media Group
The intervention group will receive traditional PT services deemed clinically appropriate via examination plus home exercise prescription augmented via a mobile health application. The augmented media group will receive digital exercise prescription via a mobile health application source (Physitrack) that includes: high definition video and pictures, education material and written instruction, reminder notification and in-app logging of completion.




Primary Outcome Measures :
  1. Adherence Exercise Logs: Adherence = exercise reps completed (x) sets completed (x) times per day completed (x) days per week completed divided by total number of (reps) (sets) (time per day) (days per week) assigned to the HEP regimen for each patient [ Time Frame: Weekly during course of patient standard treatment. Logs will be assessed over each 7 day period after initial treatment session and collected up to a period of 24 weeks or discharge from therapy intervention for any reason, which ever may occur first. ]

Secondary Outcome Measures :
  1. Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan. [ Time Frame: Completed at 1 week after inital exam , at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and 3 month follow-up. 6month follow-up if subject agreeable. ]
  2. Numeric Pain Rating Scale (NPRS) 0-10 scale. [ Time Frame: Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first. ]
  3. Patient-Specific Functional Scale (PSFS) [ Time Frame: Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first. ]
  4. The Global Rating of Change Scale (GROC) [ Time Frame: At patient discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and at 3 month follow-up. 6month follow-up if subject agreeable. ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any musculoskeletal pathology: spine, UE, LE
  2. Age18 or older
  3. Primary language is English. Ability to read, write and understand the English language
  4. Ownership of mobile smart phone
  5. Functional and cognitive ability to operate/manipulate a mobile media application
  6. Willingness to use their data package for support/use of mobile application

Exclusion Criteria:

Following the initial screening criteria, the study population will be scrutinized for exclusion.

Exclusion criteria:

  1. History of neurological pathology with neurological impairments
  2. Impaired cognition
  3. Difficulty with operation and manipulation of mobile application
  4. Difficulty with directions as set forth by the intake The exclusion criteria will be screened by written intake and a traditional medical history by the primary researcher. Subject enrollment will commence after eligibility is met and informed consent received.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035682


Locations
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United States, Ohio
Aultman Hospital - West Physical Therapy
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Health Foundation
Investigators
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Principal Investigator: Robert A Elson, MPT Aultman Health Foundation

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Responsible Party: Robert Elson PT, Physical Therapist, Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT03035682     History of Changes
Other Study ID Numbers: 2016.11RE
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Musculoskeletal Diseases