Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial
31. december 2013 opdateret af: Jonathan Paul, MD, Charlotte Sports Medicine Institute, PA
Phase I Study Comparing Internet Delivered Home Exercise Programs to Standard Orthopedic Care and Outpatient Physical Therapy.
The investigators have previously reported on patient utilization of an eRehab patient education web portal that utilizes streaming, clinician prescribed video instruction to motivate and inform patients in self-care of their orthopedic condition, focusing on the importance of a home exercise program.
The greatest barrier to patient use of this web-based home exercise treatment plan was the initial access to the program.
The purpose of this study is to compare an Internet-based patient education rehab portal (eRehab) to formal physical therapy (PT) in terms of patient costs and outcomes.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
This is a prospective, randomized, controlled pilot study.
Twenty-four patients who were candidates for a knee or shoulder orthopedic outpatient physical therapy referral were randomized to a 6-week treatment course of either PT or eRehab.
Patients were evaluated for outcome scores (KOOS or DASH), pain NRS-11 scores, patient subjective outcomes and cost of treatment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Prince Frederick, Maryland, Forenede Stater, 20678
- Advanced Orthopaedic Specialists
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28269
- Charlotte Sports Medicine Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patient diagnosed by board certified orthopedic surgeon to be in need of formal physical therapy referral
- had the ability to access and use the Internet and email
- English-speaking
- non-pregnant adults
- had not received formal physical therapy for their current diagnosis
Exclusion Criteria:
- work-related injuries
- pain NRS-11 score greater than or equal to 6
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Physical Therapy
This arm will receive the standard of care for orthopedic patients receiving a diagnosis and then a recommendation for outpatient physical therapy referral.
They will follow through on the referral and attend physical therapy.
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This intervention involves referral to a licensed physical therapist or supervised ATC-L.
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Eksperimentel: eRehab
This group will not go to formal therapy but receive Internet delivered patient education and exercise instruction.
This group will then perform those exercises at home.
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Growth in e-Health applications, defined as any computer or Internet application integrated into health services, has resulted in the development of treatment strategies to improve healthcare while reducing costs.
The utilization of e-Health to provide a rehabilitative intervention has recently been identified in the cardiac literature as "e-rehabilitation" or "eRehab."
This study specifically compares an orthopedic eRehab Internet application to standard outpatient physical therapy as an adjunct in the treatment of non-complicated knee and shoulder disorders.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Outcome scores for knee (KOOS) and shoulder (DASH)
Tidsramme: six weeks
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six weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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NRS-11 pain scores
Tidsramme: 6 weeks
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6 weeks
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patient utilization of an eRehab portal measured by number of logons and performance of a home exercise program as documented with an exercise log.
Tidsramme: 6 weeks
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6 weeks
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Patient cost of care per episode
Tidsramme: 6 months
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A patient's insurance explanation of benefits will be reviewed for 6 months from completion of the current episode of care to determine patient out of pocket expenses
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6 months
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Total cost of care per episode
Tidsramme: 6 months
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Each patient's EOB will be reviewed to determine total cost of care for each episode of care
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.
- Burden of Musculoskeletal Diseases in the United States: Prevalence, Societal and Economic Cost. Rosemont, IL, American Academy of Orthopaedic Surgeons. February 2008.
- Eng TR. The eHealth Landscape: A Terrain Map of Emerging Information and Communication Technologies in Health and Health Care. Princeton, NJ: The Robert Wood Johnson Foundation, 2001.
- Antypas K, Wangberg SC. E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial. BMC Cardiovasc Disord. 2012 Jul 9;12:50. doi: 10.1186/1471-2261-12-50.
- APTA Presentation to House Ways and Means Committee, 2011
- Farley FA, Weinstein SL. The case for patient-centered care in orthopaedics. J Am Acad Orthop Surg. 2006 Aug;14(8):447-51. doi: 10.5435/00124635-200608000-00001.
- Fatehi F, Wootton R. Telemedicine, telehealth or e-health? A bibliometric analysis of the trends in the use of these terms. J Telemed Telecare. 2012 Dec;18(8):460-4. doi: 10.1258/jtt.2012.gth108. Epub 2012 Dec 3.
- Galea MP, Levinger P, Lythgo N, Cimoli C, Weller R, Tully E, McMeeken J, Westh R. A targeted home- and center-based exercise program for people after total hip replacement: a randomized clinical trial. Arch Phys Med Rehabil. 2008 Aug;89(8):1442-7. doi: 10.1016/j.apmr.2007.11.058. Epub 2008 Jun 30.
- Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.
- Russell TG, Buttrum P, Wootton R, Jull GA. Internet-based outpatient telerehabilitation for patients following total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2011 Jan 19;93(2):113-20. doi: 10.2106/JBJS.I.01375.
- Helwig AL, Lovelle A, Guse CE, Gottlieb MS. An office-based Internet patient education system: a pilot study. J Fam Pract. 1999 Feb;48(2):123-7.
- Hill AM, McPhail S, Hoffmann T, Hill K, Oliver D, Beer C, Brauer S, Haines TP. A randomized trial comparing digital video disc with written delivery of falls prevention education for older patients in hospital. J Am Geriatr Soc. 2009 Aug;57(8):1458-63. doi: 10.1111/j.1532-5415.2009.02346.x. Epub 2009 Jun 8.
- Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L. Erratum In: Am J Ind Med 1996 Sep;30(3):372.
- Jolly K, Taylor R, Lip GY, Greenfield S, Raftery J, Mant J, Lane D, Jones M, Lee KW, Stevens A. The Birmingham Rehabilitation Uptake Maximisation Study (BRUM). Home-based compared with hospital-based cardiac rehabilitation in a multi-ethnic population: cost-effectiveness and patient adherence. Health Technol Assess. 2007 Sep;11(35):1-118. doi: 10.3310/hta11350.
- Ko V, Naylor J, Harris I, Crosbie J, Yeo A, Mittal R. One-to-one therapy is not superior to group or home-based therapy after total knee arthroplasty: a randomized, superiority trial. J Bone Joint Surg Am. 2013 Nov 6;95(21):1942-9. doi: 10.2106/JBJS.L.00964.
- Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. doi: 10.1016/j.jse.2008.06.004. Epub 2008 Oct 2.
- Mazzuca SA, Brandt KD, Katz BP, Dittus RS, Freund DA, Lubitz R, Hawker G, Eckert G. Comparison of general internists, family physicians, and rheumatologists managing patients with symptoms of osteoarthritis of the knee. Arthritis Care Res. 1997 Oct;10(5):289-99. doi: 10.1002/art.1790100503.
- McCarthy CJ, Mills PM, Pullen R, Richardson G, Hawkins N, Roberts CR, Silman AJ, Oldham JA. Supplementation of a home-based exercise programme with a class-based programme for people with osteoarthritis of the knees: a randomised controlled trial and health economic analysis. Health Technol Assess. 2004 Nov;8(46):iii-iv, 1-61. doi: 10.3310/hta8460.
- Paul JJ, Rolfes K, Herron B, Rouse J. Orthopedic eRehab: An Assessment of Patient Utilization of Internet-based Home Exercise Programs. Submitted to Am J Sports Med.
- Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
- Rozental TD, Bozentka DJ, Beredjiklian PK. Patient education through the Internet: academic and private practice sites. Clin Orthop Relat Res. 2004 Apr;(421):50-3.
- Simek EM, McPhate L, Haines TP. Adherence to and efficacy of home exercise programs to prevent falls: a systematic review and meta-analysis of the impact of exercise program characteristics. Prev Med. 2012 Oct;55(4):262-275. doi: 10.1016/j.ypmed.2012.07.007. Epub 2012 Jul 17.
- Tunay VB, Baltaci G, Atay AO. Hospital-based versus home-based proprioceptive and strengthening exercise programs in knee osteoarthritis. Acta Orthop Traumatol Turc. 2010;44(4):270-7. doi: 10.3944/AOTT.2010.2306.
- Veroff DR, Sullivan LA, Shoptaw EJ, Venator B, Ochoa-Arvelo T, Baxter JR, Manocchia M, Wennberg D. Improving self-care for heart failure for seniors: the impact of video and written education and decision aids. Popul Health Manag. 2012 Feb;15(1):37-45. doi: 10.1089/pop.2011.0019. Epub 2011 Oct 17.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2012
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
26. december 2013
Først indsendt, der opfyldte QC-kriterier
31. december 2013
Først opslået (Skøn)
1. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. december 2013
Sidst verificeret
1. december 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- eRehab101
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .