- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02659280
Using "Store and Forward" Tele-health as an Adjunct to Traditional Outpatient or Home Health Physical Therapy (TELE)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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,
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Standard of Care Therapy
Home Health or Outpatient Physical therapy services (a minimum of 1x/week).
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Standard of Care Outpatient Physical Therapy
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Experimental: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Improved compliance with Physical Therapy Home Exercise Program
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MinneapolisMRF
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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