- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03035682
The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT
23. august 2020 oppdatert av: Robert Elson PT, Aultman Health Foundation
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
Ohio
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Canton, Ohio, Forente stater, 44710
- Aultman Hospital - West Physical Therapy
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Traditional Group
The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription.
|
The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.
|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: 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.
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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.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan.
Tidsramme: 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.
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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.
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Numeric Pain Rating Scale (NPRS) 0-10 scale.
Tidsramme: 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.
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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.
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Patient-Specific Functional Scale (PSFS)
Tidsramme: 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.
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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.
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The Global Rating of Change Scale (GROC)
Tidsramme: 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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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Robert A Elson, MPT, Aultman Health Foundation
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. januar 2017
Primær fullføring (Faktiske)
23. juli 2018
Studiet fullført (Faktiske)
12. desember 2019
Datoer for studieregistrering
Først innsendt
18. januar 2017
Først innsendt som oppfylte QC-kriteriene
26. januar 2017
Først lagt ut (Anslag)
30. januar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. august 2020
Sist bekreftet
1. august 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016.11RE
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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