Orthopedic DisorderNCT03035682
The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT
A study testing Augmented Media Group and Traditional Group in people with Orthopedic Disorder and Musculoskeletal Injury, run by Aultman Health Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Orthopedic Disorder, Musculoskeletal Injury
- What is being tested?
- Augmented Media Group and Traditional Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Following the initial screening criteria, the study population will be scrutinized for exclusion.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aultman Hospital - West Physical Therapy
Canton, Ohio, 44710
About this study
Official title: The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- Augmented Media Group, Traditional Group
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Media GroupOther
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.
Traditional GroupOther
The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Group | Active comparator | The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription. Receives: 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. Receives: Other: Augmented Media Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start23 Jan 2017
- Primary completion23 Jul 2018
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aultman Health Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Elson PT, Aultman Health Foundation
- Investigators
- Robert A Elson, MPT, Principal investigator, Aultman Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035682
- Sponsor's protocol ID
- 2016.11RE
- Status last verified
- Aug 2020
- First submitted
- 18 Jan 2017
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03035682
- Acronym / sponsor ID
- 2016.11RE
- Conditions
- Orthopedic Disorder, Musculoskeletal Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Aultman Health FoundationUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Group | Active comparator | Other: Traditional GroupThe control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription. |
| Augmented Media Group | Experimental | Other: Augmented Media GroupThe Augmented Media group will receive traditional PT services as deemed clinically appropriate via examination and include home exercise prescription via a mobile health application. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Following the initial screening criteria, the study population will be scrutinized for exclusion.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Media GroupThe 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. | Other | Augmented Media Group |
| Traditional GroupThe Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription. | Other | Traditional Group |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Elson, MPT principal investigator
Aultman Health Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Media Group and Traditional Group in people with Orthopedic Disorder and Musculoskeletal Injury, run by Aultman Health Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.