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

NCT03035682 | Completed

• 1 other identifier: 2016.11RE
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder; Musculoskeletal Injury

Outcome Measures

Primary Outcomes (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

  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 Outcomes (4)

• Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan.

  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.

• Numeric Pain Rating Scale (NPRS) 0-10 scale.

  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.

• Patient-Specific Functional Scale (PSFS)

  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.

• The Global Rating of Change Scale (GROC)

  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.

Study Arms (2)

Traditional Group

ACTIVE COMPARATOR

The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription.

Other: Traditional Group

Augmented Media Group

EXPERIMENTAL

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

Interventions

Augmented Media Group OTHER

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.

Augmented Media Group

Traditional Group OTHER

The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.

Traditional Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of neurological pathology with neurological impairments
• Impaired cognition
• Difficulty with operation and manipulation of mobile application

Sponsors & Collaborators

• Aultman Health Foundation: lead

Study Sites (1)

Aultman Hospital - West Physical Therapy

Canton, Ohio, 44710, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Robert A Elson, MPT

  Aultman Health Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 30, 2017
• Study Start: January 23, 2017
• Primary Completion: July 23, 2018
• Study Completion: December 12, 2019
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)