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

NCT ID: NCT03035682

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-23
• Study Completion Date: 2019-12-12

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.

Conditions

Orthopedic Disorder; Musculoskeletal Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Group

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

Group Type: ACTIVE_COMPARATOR

Traditional Group

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Augmented Media Group

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Traditional Group

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

Intervention Type: OTHER

Eligibility 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.

1. History of neurological pathology with neurological impairments

2. Impaired cognition

3. Difficulty with operation and manipulation of mobile application

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aultman Health Foundation

OTHER

Sponsor Role: lead

Responsible Party

Robert Elson PT

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert A Elson, MPT

Role: PRINCIPAL_INVESTIGATOR

Aultman Health Foundation

Locations

Aultman Hospital - West Physical Therapy

Canton, Ohio, United States

Countries

United States

Other Identifiers

2016.11RE

Identifier Type: -

Identifier Source: org_study_id