- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02659280
Using "Store and Forward" Tele-health as an Adjunct to Traditional Outpatient or Home Health Physical Therapy (TELE)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Hennepin Health System (HHS) will determine participant's eligibility in the pilot project if a participant meets the following stipulations; 1) The prospective participant must be an Hennepin Health Services outpatient or home health Physical Therapy (PT) patient. 2) The prospective participant's primary PT and Primary Investigator must determine that the participant has adequate motor control to participate in a HEP (home exercise program) on their own. 3) The prospective participant's primary PT and Primary Investigator must determine that the prospective participant has adequate cognitive ability to use electronic assistive technology (iPad Mini 4). The prospective participant will need to live greater than 100 miles from Minneapolis and/or needs to have financial hardship (as designated by being on Medical Assistance, Emergency Medical Assistance, Hennepin Care, Medicaid, Medical Assistance Cost Plan, Wavered services or have no health insurance).
Note: The prospective participant may receive home health or outpatient PT at another facility other than Hennepin Health System (HHS), if they are from greater than 100 miles from Minneapolis (but the participant's care will need to be tied to a HHS admission).
The tele-health will be administered in the following manner;
- The participant's primary PT will determine the appropriateness for this adjunct therapy and contact the tele-therapist/Primary Investigator, Casey Byron, MPT.
- Casey Byron, MPT will perform a chart review and interview the participant to determine if they meet eligibility requirements.
- Participant will sign the pilot program contract agreement, informed consent agreement and terms and conditions for the Hudl Technique app. The participant will be given information on how to operate the iPad Mini 4, how to use the Hudl Technique app and be given information on what to do if problems occur.
- The participant's primary PT will discuss the home exercise program (HEP) that they wish for the participant to perform with the tele-therapist.
- The tele-therapist will formulate an audio/video clip through Hudl Technique of the HEP and send it to the participant.
- The participant will record their performance of the HEP using the Hudl Technique app, iPad Mini 4 and iPad Mini 4 tripod and send their audio/video clip back to the tele-therapist.
- The video clip will be analyzed by the tele-therapist. Hudl Technique tools such as slow motion video, comparing two videos side by side, measuring angles, highlighting points of emphasis, and an audio voice over will be used to formulate a critiqued video clip.
- The critiqued video clip will be sent back to the participant.
- The participant will view the critiqued video clip and await the next video. ***There will be a maximum of 1 HEP per week.***
- The tele-health PT and participant's primary PT will correspond for updates to participant's HEP.
- The critiqued video clip will be "deleted" from the tele-therapists Hudl Technique account (HHS will not store any video clips that we generate).
Study Parameters to be Measured:
Participants will need to agree to data analytics of their electronic medical record (EMR). We will need access to information like payer source, diagnoses, address, and past and future emergency department and inpatient visits to the hospital. This will be performed through EMR review here at HHS and a survey for participants living greater than 100 miles from Minneapolis. The Hudl Technique app and a survey will allow for measurement of adherence to HEP. Participant's satisfaction with tele-health will be measured via survey (Modified Patient Satisfaction with Outpatient Physical Therapy Scale)1. Participants would be encouraged to allow the use of the Apple Health Kit. Participants would be encouraged to enter data in the Apple Health Kit, on a regular basis. This IOS/Apple program would allow for the measurement of changes that occur to a participant's body measurements (height, weight, and body mass index) with this adjunct therapy. The participant's use of the Apple Health Kit would be voluntary. Body weight measurements would also be assessed via survey.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55415
- Hennepin County Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Hennepin Health System (HHS) will determine participant's eligibility in the pilot project if a participant meets the following stipulations
- The prospective participant must be an HHS outpatient or home health Physical Therapy (PT) patient.
- The prospective participant's primary PT must determine that the participant has adequate motor control to participate in a HEP (home exercise program) on their own.
- The prospective participant has adequate cognitive ability to use electronic assistive technology (iPad Mini
- The prospective participant will need to live greater than 100 miles from Minneapolis and/or needs to have financial hardship (as designated by being on Medical Assistance, Emergency Medical Assistance, Hennepin Care, Medicaid, Medical Assistance Cost Plan, Wavered services or have no health insurance).
Exclusion Criteria:
- Any participant less than the age of 18 years of age. Any participant who is pregnant or has reason to beleive they are pregnant,
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Standard of Care Therapy
Home Health or Outpatient Physical therapy services (a minimum of 1x/week).
|
Standard of Care Outpatient Physical Therapy
|
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Sperimentale: Adjunct Therapy
Home Health or Outpatient Physical therapy services (a minimum of 1x/week) with an adjunct Home Exercise Program given up to 1x/wk via "Store and Forward" tele-health through the Hudl Technique app.
|
"Store and Forward" Tele-heath
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Improved compliance with Physical Therapy Home Exercise Program
Lasso di tempo: 24 weeks
|
Subjects will have statistically significant improvement in the frequency of performing their Home Exercise Program (HEP).
This will be measured via survey with the modified Patient Satisfaction for Outpatient Physical Therapy Survey.
|
24 weeks
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Beattie PF, Pinto MB, Nelson MK, Nelson R. Patient satisfaction with outpatient physical therapy: instrument validation. Phys Ther. 2002 Jun;82(6):557-65. Erratum In: Phys Ther 2002 Aug;82(8):827.
- Van de Winckel A, Nawshin T, Byron C. Combining a Hudl App With Telehealth to Increase Home Exercise Program Adherence in People With Chronic Diseases Experiencing Financial Distress: Randomized Controlled Trial. JMIR Form Res. 2021 Mar 18;5(3):e22659. doi: 10.2196/22659.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MinneapolisMRF
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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