- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02659280
Using "Store and Forward" Tele-health as an Adjunct to Traditional Outpatient or Home Health Physical Therapy (TELE)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Minnesota
-
Minneapolis, Minnesota, Spojené státy, 55415
- Hennepin County Medical Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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,
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Standard of Care Therapy
Home Health or Outpatient Physical therapy services (a minimum of 1x/week).
|
Standard of Care Outpatient Physical Therapy
|
|
Experimentální: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Improved compliance with Physical Therapy Home Exercise Program
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MinneapolisMRF
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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