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

Primary Purpose

Orthopedic Disorder, Musculoskeletal Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented Media Group
Traditional Group
Sponsored by
Aultman Health Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aultman Hospital - West Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Group

Augmented Media Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan.
Numeric Pain Rating Scale (NPRS) 0-10 scale.
Patient-Specific Functional Scale (PSFS)
The Global Rating of Change Scale (GROC)

Full Information

First Posted
January 18, 2017
Last Updated
August 23, 2020
Sponsor
Aultman Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03035682
Brief Title
The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT
Official Title
The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aultman Health Foundation

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Musculoskeletal Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Group
Arm Type
Active Comparator
Arm Description
The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription.
Arm Title
Augmented Media Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Augmented Media Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Group
Intervention Description
The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Following the initial screening criteria, the study population will be scrutinized for exclusion. Exclusion criteria: History of neurological pathology with neurological impairments Impaired cognition Difficulty with operation and manipulation of mobile application 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Elson, MPT
Organizational Affiliation
Aultman Health Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aultman Hospital - West Physical Therapy
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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