- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07790484
Assessing Feasibility of Evaluating Provider Experience With a Remote Therapeutic Monitoring Platform
25 de agosto de 2026 atualizado por: Adly A Adam
Assessing Feasibility of Evaluating Provider Experience With a Remote Therapeutic Monitoring Platform: A Cross-Sectional Survey of Clinician Workload, Therapeutic Alliance, and Satisfaction
: Remote therapeutic monitoring (RTM) platforms were increasingly deployed in Outpatient Rehabilitation to support continuous, between-visit communication, adherence to home exercise programs, and earlier identification of clinical setbacks.
While patient-facing outcomes have received growing attention, evidence describing the clinician experience of RTM; including its effects on therapeutic alliance, perceived cognitive workload, and capacity for proactive patient management remains limited.
Understanding how providers perceive and integrate RTM technology into their workflows is essential to optimizing implementation, sustaining adoption, and translating digital health investment into measurable clinical value.
This cross-sectional survey study tested the feasibility of evaluating the provider's experience using a digital RTM platform across three pre-specified domains: 1) therapeutic alliance, 2) work satisfaction, plus cognitive loading, and 3) proactive patient management.
A secondary objective examined whether years of clinical experience or self-reported comfort with new technology were associated with provider experience or perceived workload.A cross-sectional, anonymous survey was administered to licensed physical therapists at the Outpatient Clinics, Shebin El-Kom, Menofyia governate, Egypt between 1st March, and 31th July, 2026 with a response rate of 43.4% (43/99) for the completed surveys.
Eligible clinicians used the SaRA Health RTM platform for at least the previous six months prior to initiation of current study.
The survey instrument combined an internally developed 8-item Likert-scale survey (0-5) targeting therapeutic alliance, proactive management, and satisfaction (Cronbach's α = 0.89) with a modified NASA Task Load Index (NASA-TLX; Cronbach's α = 0.86) measured the perceived workload across six domains (0-10).
Cronbach's α coefficient demonstrates internal consistency, unless not construct validity or test-retest reliability.
Statistical analyses included Spearman rank-order correlations and Mann-Whitney-U tests.
For Mann-Whitney comparisons, results were reported as: U, p-value, group sample sizes (N1, N2), and rank-biserial r-effect size.
For multiple comparisons across NASA-TLX subscales (k = 6), a Bonferroni-corrected threshold of α = .0083
was applied.
Spearman correlations were reported with ρ and 95% confidence intervals.In this cross-sectional survey feasibility study, it was observed that clinician experience with the SaRA Health RTM platform was characterized by enhanced therapeutic alliance when early warning detection performed well, reduced cognitive load was observed when frustration was low, and meaningful facilitation of proactive patient management was observed among engaged users.
Frustration emerged as the most actionable lever for design and implementation improvement, and self-reported digital comfort rather than years of clinical experience was the strongest clinician-level correlate of cognitive burden.
These findings suggest that targeted onboarding, mentorship, and friction-reducing platform refinements may improve RTM adoption and amplify downstream benefits to patient care.
Larger, multi-site, longitudinal studies are warranted to validate these signals.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
Remote Therapeutic Monitoring (RTM) has emerged as an increasingly important component of contemporary rehabilitation delivery, particularly within outpatient musculoskeletal care.
The introduction of RTM-specific CPT codes beginning in 2022 to include patient-reported subjective data, has created reimbursement pathways that support integration of RTM into physical therapy practice by enabling clinicians to monitor patient progress, adherence, symptoms, and treatment response between in-person visits.
Digital-health technologies may strengthen this alliance by providing easy access to communication with clinicians in between visits, enhancing continuity, and supporting personalized feedback between visits.
Recent evidence suggests that digital-health interventions can positively influence patient-provider relationships when technologies are perceived as supportive rather than intrusive or burdensome.
A feasibility, cross-sectional, quantitative survey was conducted at the Outpatient Clinics, Shebin El-Kom, Menofyia governate, Egypt between 1st March, and 31th July, 2026.
The Outpatient Clinics provide care to adult patients with musculoskeletal, and neuromuscular conditions.
Participating clinicians were defined as licensed physical therapists (PTs).
All participants were recruited voluntarily and checked an informed consent box through an emailed request.
Across three pre-specified objectives for this cross-sectional, quantitative survey study, the SaRA Health RTM platform demonstrated observational signals consistent with improved therapeutic alliance when early warning detection performed well, reduced cognitive load when frustration with the platform was minimized, and meaningful facilitation of proactive patient management among clinicians who experienced the RTM process as positive.
Frustration emerged as the single most actionable target for improvement, and lower self-reported digital comfort was the clinician characteristic most associated with elevated cognitive load and reduced performance on the modified NASA task index.
Together these findings suggest clinician experience design, education, and training as important determinants of whether this specific RTM platform translates into the proactive, alliance-strengthening care it is intended to enable.
Tipo de estudo
Observacional
Inscrição (Real)
45
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Menofyia
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Shibīn al Kawm, Menofyia, Egito, 11432
- Shebin ElKom Teaching Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Clinicians used the SaRA Health RTM platform for at least the previous six months prior to initiation of current study.
Licensed physical therapists providing Outpatient care to adult patients at the Outpatient Clinics, Shebin El-Kom, Menofyia governate, Egypt, who had used the SaRA Health RTM platform at least six months prior and during the study period.
Exclusion: clinicians without direct RTM-platform exposure and respondents with incomplete surveys on key outcome items.
Descrição
Inclusion Criteria:
- Licensed physical therapists providing Outpatient care to adult patients at the Outpatient Clinics, Shebin El-Kom, Menofyia governate, Egypt, who had used the SaRA Health RTM platform at least six months prior and during the study period.
- A range of physical therapy experience levels and professions.
- Clinicians used the SaRA Health RTM platform for at least the previous six months prior to initiation of current study.
Exclusion Criteria:
- Clinicians without direct RTM-platform exposure and respondents with incomplete surveys on key outcome items
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Experimental Group
45 Licensed physical therapists providing Outpatient care to adult patients at the Outpatient Clinics, Shebin El-Kom, Menofyia governate, Egypt, who had used the SaRA Health RTM platform at least six months prior and during the study period.
Exclusion: clinicians without direct RTM-platform exposure and respondents with incomplete surveys on key outcome items.
Participants represent a range of experience levels and professions.
Respondents were asked about their comfort with technology, the number of patient-care hours they delivered weekly, and the proportion of their caseload enrolled on the SaRA Health RTM platform
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The survey was administered anonymously and consisted of two principal instruments: 1) an internally developed 8-item Likert-scale survey examining clinician experiences with the SaRA Health RTM platform and its perceived contribution to patient care plans, and 2) a modified, non-validated NASA Task Load Index (NASA-TLX) that captured perceived cognitive and physical workload, time pressure, performance (defined as the ability to complete work), effort, and frustration associated with platform use.
The validated tool is generally used without modification using a 0-100 scale.
We modified the scale to 0-10 with '0' representing the lowest end of each domain.
The internally developed survey, designed by the SaRA Health research team, comprised 8 items rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree).
Items targeted clinician perceptions of therapeutic alliance, proactive patient management, and work satisfaction associated with use of the RTM system.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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A modified, non-validated NASA Task Load Index (NASA-TLX)
Prazo: 1. At base-line of the study.
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A modified, non-validated NASA Task Load Index (NASA-TLX) measures perceived workload of human-machine systems across six domains and has been used extensively in the healthcare field to exam workload for providers using digital health technologies.
The validated tool is generally used without modification using a 0-100 scale.
We modified the scale to 0-10 with '0' representing the lowest end of each domain.
For example, a score of 0 on the mental demand item indicates no additional mental load attributable to the system, whereas a score of '10' indicates extremely high additional mental load.
The original instrument served as a template; item wording was lightly modified to reflect the RTM use case more specifically.
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1. At base-line of the study.
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An internally developed 8-item Likert-scale survey
Prazo: 1. At base-line of the study.
|
An internally developed 8-item Likert-scale survey designed by the SaRA Health research team, comprised 8 items rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree).
Items targeted clinician perceptions of therapeutic alliance, proactive patient management, and work satisfaction associated with use of the RTM system.
|
1. At base-line of the study.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de março de 2026
Conclusão Primária (Real)
1 de junho de 2026
Conclusão do estudo (Real)
30 de julho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
23 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de agosto de 2026
Primeira postagem (Real)
27 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HSH00192
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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