- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02358135
Collaborative Connected Health (CCH) for PCORI (PCORI)
Collaborative Connected Health (CCH): A Pragmatic Trial Evaluating Effectiveness of CCH in Psoriasis Management Compared to In-person Visits.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90089
- University of Southern California
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Sacramento, California, Estados Unidos, 95817
- University of California Davis School of Medicine
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Denver
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be age 18 years and older
- Have physician-diagnosed plaque psoriasis
- Have access to internet and a digital camera or a mobile phone with camera features
- Have a primary care provider or the ability to establish primary care
Exclusion Criteria:
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Control
In-person care is the control group because it is currently considered the standard of care in delivering dermatologic services.
The intervention includes regular visits to a physician, and may include such treatments as ointments, steroids or ultraviolet therapy at the discretion of a physician.
In-person care is the major healthcare-delivery model for managing chronic skin diseases and a realistic, primary option that patients face.
The patients in the in-person arm can seek psoriasis care from primary care practitioners or dermatologists, just as they would in the real world.
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In-person care is the control group because it is currently considered the standard of care in delivering dermatologic services.
The intervention includes regular visits to a physician, and may include such treatments as ointments, steroids or UV therapy at the discretion of a physician.
In-person care is the major healthcare-delivery model for managing chronic skin diseases and a realistic, primary option that patients face.
The patients in the in-person arm can seek psoriasis care from PCPs or dermatologists, just as they would in the real world.
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Experimental: CCH Model
The intervention arm will be the collaborative connected health (CCH) model, which purports to increase access to specialists and improve outcomes.
Specifically, CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously.
CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists.
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CCH is an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments.
Likewise, practitioners can request and/or initiate dermatology consultations, assume longitudinal care or communicate with patients directly.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI)
Periodo de tiempo: 12 months
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Participants are asked to complete self-administered Psoriasis Area and Severity Index (SA-PASI).
SA-PASI combines the assessment of lesion severity (erythema, induration, and scale) and the affected areas into a single score between 0 (no disease) to 72 (maximal disease).
The primary outcome of the study was the mean percent improvement in SA-PASI averaged over three, six, nine, and 12 months.
The percent improvement in SA-PASI was defined as the difference in SA-PASI scores between the baseline and each of the follow-up visits divided by the SA-PASI score from the baseline visit.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments
Periodo de tiempo: 12 months
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Quality of life will be assessed using dermatology-specific, quality of life instruments, Skindex-16 and Dermatology Life Quality Index (DLQI). Scores for these assessments will be compared between patients randomized to the CCH model and in-person care. Skindex-16 is a validated and reliable instrument that comprehensively captures the effects of skin disease on health-related quality of life. It discriminates among patients with different effects and is responsive to clinical changes over time. Skindex-16 scores range from 0 (no effect) to 100 (effect experienced all the time), and the responses are aggregated in symptoms, emotions, and functioning subscales. The Dermatology Life Quality Index (DLQI) is another validated dermatology-specific quality-of-life instrument that has been used in many psoriasis trials. DLQI scores range from 0 to 30, with higher scores indicating more severe impact on quality of life. |
12 months
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Access to Care: Distance Traveled
Periodo de tiempo: 12 months.
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Access to care is an overall term to capture the transportation to care factors including total distance traveled to see a provider (round-trip driving distance from patient's home to provider's office multiplied by the number of in-person visits during the study period).
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12 months.
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Depression Severity
Periodo de tiempo: 12 months
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Participants will be assessed for depression severity using the Patient Health Questionnaire (PHQ), a validated, self-administered diagnostic instrument for common mental disorders. The PHQ-9 score can range from 0 to 27 with 0 = "No" depression and 27 = "Severe" depression. The PHQ is a validated, self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) depression criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score of 10 or greater has 89% sensitivity and 88% specificity for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. PHQ-9 is a validated tool for diagnosis of depression and monitoring response to interventions. |
12 months
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Other Psoriasis Disease Severity Measures
Periodo de tiempo: 12 months
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Body surface area (BSA) involvement and patient global assessment (PtGA) will be compared between the patients randomized to the CCH model and the in-person care. The BSA assessment is a well-established, validated measure used by psoriasis patients to report percent body surface affected by psoriasis in numerous prior studies. BSA ranges from 0% (no involvement) to 100% (complete body surface affected). The PtGA is a validated instrument that measures the overall psoriasis severity from the patients' perspective.40 PtGA is an ordinal six-point scale ranging from 0 (clear) to 5 (severe). |
12 months
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Access to Care: Wait Time
Periodo de tiempo: 12 months
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Access to care is an overall term to capture transportation factors including time taken to be seen by a provider.
me.
Wait time is measured by calculating roundtrip transportation time plus in-office waiting time multiplied by the number of in-person visits during the study period.
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12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: April Armstrong, MD MPH, University of Southern California
Publicaciones y enlaces útiles
Publicaciones Generales
- Armstrong AW, Chambers CJ, Maverakis E, Cheng MY, Dunnick CA, Chren MM, Gelfand JM, Wong DJ, Gibbons BM, Gibbons CM, Torres J, Steel AC, Wang EA, Clark CM, Singh S, Kornmehl HA, Wilken R, Florek AG, Ford AR, Ma C, Ehsani-Chimeh N, Boddu S, Fujita M, Young PM, Rivas-Sanchez C, Cornejo BI, Serna LC, Carlson ER, Lane CJ. Effectiveness of Online vs In-Person Care for Adults With Psoriasis: A Randomized Clinical Trial. JAMA Netw Open. 2018 Oct 5;1(6):e183062. doi: 10.1001/jamanetworkopen.2018.3062.
- Armstrong AW, Ford AR, Chambers CJ, Maverakis E, Dunnick CA, Chren MM, Gelfand JM, Gibbons CM, Gibbons BM, Lane CJ. Online Care Versus In-Person Care for Improving Quality of Life in Psoriasis: A Randomized Controlled Equivalency Trial. J Invest Dermatol. 2019 May;139(5):1037-1044. doi: 10.1016/j.jid.2018.09.039. Epub 2018 Nov 24.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HS-15-00417
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Soriasis
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ProgenaBiomeReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Rostro de psoriasis | Clavo de la psoriasis | Psoriasis difusa | Psoriasis Punctata | Psoriasis palmar | Psoriasis circinata | Psoriasis anular | Psoriasis genital | Psoriasis GeográficaEstados Unidos
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Centre of Evidence of the French Society of DermatologyReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Psoriasis palmar | Eritrodermia psoriásica | Uña psoriásica | Psoriasis en gotas | Psoriasis inversa | Psoriasis pustulosaFrancia
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Clin4allReclutamientoPsoriasis del cuero cabelludo | Clavo de la psoriasis | Psoriasis palmar | Psoriasis genital | Psoriasis plantarFrancia
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Herlev and Gentofte HospitalReclutamientoInfarto de miocardio | Isquemia miocardica | Enfermedades cardíacas | Enfermedades cardiovasculares | Insuficiencia cardiaca | Carrera | Soriasis | Insuficiencia Cardíaca Diastólica | Psoriasis vulgar | Factor de riesgo cardiovascular | Insuficiencia Cardíaca Sistólica | Disfunción Ventricular Izquierda | Psoriasis... y otras condicionesDinamarca
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UCB Biopharma S.P.R.L.TerminadoPsoriasis moderada a severa | Psoriasis Pustular Generalizada y Psoriasis EritrodérmicaJapón
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Innovaderm Research Inc.TerminadoPsoriasis del cuero cabelludo | Psoriasis pustulosa palmo-plantar | Psoriasis palmoplantar no pustulosa | Psoriasis de codo | Psoriasis de la parte inferior de la piernaCanadá
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AmgenTerminadoPsoriasis tipo psoriasis | Psoriasis tipo placaEstados Unidos
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TakedaReclutamientoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
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Assiut UniversityDesconocidoPacientes con psoriasis
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Janssen Pharmaceutical K.K.ReclutamientoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
Ensayos clínicos sobre Control
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Yonsei UniversityAún no reclutandoHipertensión | Enfermedades Renales Crónicas | DislipidemiasCorea, república de
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Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainDesconocidoUn Procedimiento Breve de Regulación Emocional (PbRE) para la Fibromialgia Utilizando las TIC (PbRE)Dolor crónico | FibromialgiaEspaña
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University Hospital, LilleTerminado
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Takeshi MorimotoUniversity of the RyukyusActivo, no reclutandoEnfermedad de la arteria coronaria | Hipertensión | Diabetes tipo 2 | DislipidemiaJapón
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University of California, San FranciscoRetiradoLesión pulmonar aguda
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National Taiwan University HospitalTerminado
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Federal University of Health Science of Porto AlegreTerminado
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Xuanwu Hospital, BeijingBeijing Tiantan Hospital; Peking University Third Hospital; The 306 Hospital of...DesconocidoRevascularización Cerebral | Enfermedad cerebrovascular isquémicaPorcelana
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James J. Peters Veterans Affairs Medical CenterKessler FoundationTerminadoEl flujo sanguíneo cerebral | Presión arterial | Función cognitiva | Lesión de la médula espinalEstados Unidos
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Cornell UniversityTerminadoVoluntarios SaludablesEstados Unidos