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Evaluation of Allied Healthcare in Patients Recovering From COVID-19 (ParaCOV)

9 de mayo de 2022 actualizado por: Radboud University Medical Center

SUMMARY Rationale: Allied health professionals (i.e., dietitians, exercise therapists, physical therapists, occupational therapists and speech and language therapists) might play an important role in the recovery of patients with COVID-19 who experience limitations in daily physical functioning and participation. However, the evidence base for allied healthcare in patients with COVID-19 has yet to be established. To facilitate care for people recovering from COVID-19 and to establish this evidence base, the Dutch ministry has created a temporary regulation for primary care allied healthcare specifically for patients with COVID-19.

Objective: This study is setup alongside the temporary regulation and aims to evaluate the longitudinal recovery trajectories and related costs of patients who visited a primary care allied healthcare professional for the management of severe symptoms and activity limitations and/or participation restrictions related to COVID-19.

Study design: Prospective cohort study. Study population: 1,315 adult patients recovering from COVID-19 with severe symptoms and activity limitations and/or participation restrictions, and who are referred to a primary care allied health professional by a general practitioner or medical specialist within four months of the start of the disease will be eligible for this study.

Intervention (if applicable): Although the nature of this study is non-experimental, the allied healthcare intervention can be considered experimental due to the novelty of the disease.

Main study parameters/endpoints: The primary outcome domain of this study is participation measured with the Utrechtse Schaal voor Revalidatie - Participatie (USER-P). The primary endpoint is set at 6 months. A 5 point difference will be considered clinically relevant for patients with COVID-19.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no specific risks involved with participation in this study, as it entails the completion of questionnaires over the timeframe of one year (at the start of the treatment, the end of the treatment, 3 months, 6 months, 9 months and 12 months). The load of the survey will be highest at months 3, 6 and 12 with a total of 74 survey items. Input from patient representatives suggested that this number of items was feasible, especially because participants are allowed to complete the survey over a number of days. Finally, none of the items in the survey are considered emotionally distressing. The prescribed interventions are conform the recommendations of the best available evidence and are in line with usual allied healthcare interventions. Therefore, risks are likely to be negligible conform usual allied healthcare.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

1441

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Gelderland
      • Nijmegen, Gelderland, Países Bajos, 6500HB
        • Radboud University Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Adult patients of 18 year and older recovering from COVID-19 with severe symptoms and activity limitations and/or participation restrictions, who are referred to a primary care allied health professional* by a general practitioner or medical specialist are deemed eligible for this study.

*Allied health professionals relevant to this study are: Dietitians, Exercise Therapists, Occupational Therapists, Physical Therapists, and Speech and Language Therapists working in primary care in the Netherlands.

Descripción

Inclusion Criteria:

Adult patients

  • recovering from COVID-19 with severe symptoms and activity limitations and/or participation restrictions, and;
  • who are referred to a primary care allied health professional by a general practitioner or medical specialist within four months of the start of the disease; will be eligible for this study. The need for referring the patient to an allied health professional will be judged by the primary care physician or medical specialist. Criteria for referral are described in guidance published by the Long Alliantie Nederland (LAN) with recommendations for treatment of post-COVID-19-patients: the COVID-19 Associated Syndrome (CAS) (Chapters 3.3 and 4).

http://www.longalliantie.nl/files/2515/9359/4621/Handreiking_voor_de_zorg.pdf

Exclusion Criteria:

Adult patients:

- receiving palliative care; are excluded from this study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Prospective cohort
Allied health professionals (i.e., dietitians, exercise therapists, physical therapists, occupational therapists and speech and language therapists) that treat patients recovering from COVID-19 in Dutch primary care
We will not develop specific interventions for this prospective observational cohort study. The care provided by allied health professionals in daily practice are based on recommendations published by the professional bodies of allied health professionals and on the interdisciplinary guidance developed by the LAN. All allied health professionals are working according to these recommendations. Dissemination of these recommendations is done by the professional bodies of the allied health professionals. Given the observational nature of our study, no additional implementation strategies will be employed to stimulate this care by the research group.
Retrospective cohort
Allied health professionals (i.e., dietitians, exercise therapists, physical therapists, occupational therapists and speech and language therapists) that have been treated patients recovering from COVID-19 in Dutch primary care
We will not develop specific interventions for this prospective observational cohort study. The care provided by allied health professionals in daily practice are based on recommendations published by the professional bodies of allied health professionals and on the interdisciplinary guidance developed by the LAN. All allied health professionals are working according to these recommendations. Dissemination of these recommendations is done by the professional bodies of the allied health professionals. Given the observational nature of our study, no additional implementation strategies will be employed to stimulate this care by the research group.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participation
Periodo de tiempo: Baseline (T0)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Baseline (T0)
Participation
Periodo de tiempo: 3 months (T1)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
3 months (T1)
Participation
Periodo de tiempo: 6 months (T2)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
6 months (T2)
Participation
Periodo de tiempo: 12 months (T3)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
12 months (T3)
Quality of life measured with EQ-5D-5L
Periodo de tiempo: Baseline (T0)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Baseline (T0)
Quality of life measured with EQ-5D-5L
Periodo de tiempo: 3 months (T1)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
3 months (T1)
Quality of life measured with EQ-5D-5L
Periodo de tiempo: 6 months (T2)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
6 months (T2)
Quality of life measured with EQ-5D-5L
Periodo de tiempo: 12 months (T3)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
12 months (T3)
Fatigue
Periodo de tiempo: Baseline (T0)
Measured with the Fatigue Severity Scale (FSS)
Baseline (T0)
Fatigue
Periodo de tiempo: 3 months (T1)
Measured with the Fatigue Severity Scale (FSS)
3 months (T1)
Fatigue
Periodo de tiempo: 6 months (T2)
Measured with the Fatigue Severity Scale (FSS)
6 months (T2)
Fatigue
Periodo de tiempo: 12 months (T3)
Measured with the Fatigue Severity Scale (FSS)
12 months (T3)
Physical functioning
Periodo de tiempo: Baseline (T0)
PROMIS Physical Functioning Short Form 10b (10 items).
Baseline (T0)
Physical functioning
Periodo de tiempo: 3 months (T1)
PROMIS Physical Functioning Short Form 10b (10 items).
3 months (T1)
Physical functioning
Periodo de tiempo: 6 months (T2)
PROMIS Physical Functioning Short Form 10b (10 items).
6 months (T2)
Physical functioning
Periodo de tiempo: 12 months (T3)
PROMIS Physical Functioning Short Form 10b (10 items).
12 months (T3)
Costs
Periodo de tiempo: Baseline (T0)
will be measured using a cost questionnaire (18 items)
Baseline (T0)
Costs
Periodo de tiempo: 3 months (T1)
will be measured using a cost questionnaire (18 items)
3 months (T1)
Costs
Periodo de tiempo: 6 months (T2)
will be measured using a cost questionnaire (18 items)
6 months (T2)
Costs
Periodo de tiempo: 9 months (T3)
will be measured using a cost questionnaire (18 items)
9 months (T3)
Costs
Periodo de tiempo: 12 months (T4)
will be measured using a cost questionnaire (18 items)
12 months (T4)
Patient Specific Activities
Periodo de tiempo: baseline (T0) as part of usual care
measured with the Patient Specific Complaints (PSC)
baseline (T0) as part of usual care
Patient Specific Activities
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the Patient Specific Complaints (PSC)
end of the treatment as part of usual care (average of 6 months)
Nutritional Status
Periodo de tiempo: baseline (T0) as part of usual care
measured with the BMI (weight and height)
baseline (T0) as part of usual care
Nutritional Status
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the BMI (weight and height)
end of the treatment as part of usual care (average of 6 months)
Global Assessment
Periodo de tiempo: baseline (T0) as part of usual care
measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
baseline (T0) as part of usual care
Global Assessment
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
end of the treatment as part of usual care (average of 6 months)
Voice Problems
Periodo de tiempo: baseline (T0) as part of usual care
measured with Voice Handicap Index (VHI)
baseline (T0) as part of usual care
Voice Problems
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with Voice Handicap Index (VHI)
end of the treatment as part of usual care (average of 6 months)
Swallowing Problems
Periodo de tiempo: baseline (T0) as part of usual care
Dysphagia Handicap Index (DHI).
baseline (T0) as part of usual care
Swallowing Problems
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
Dysphagia Handicap Index (DHI).
end of the treatment as part of usual care (average of 6 months)
Patient Specific Activities
Periodo de tiempo: baseline (T0) as part of usual care
measured with the Canadian Occupational Performance Measure (COPM)
baseline (T0) as part of usual care
Patient Specific Activities
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the Canadian Occupational Performance Measure (COPM)
end of the treatment as part of usual care (average of 6 months)
Activities
Periodo de tiempo: baseline (T0) as part of usual care
measured with the PRO-ergo
baseline (T0) as part of usual care
Activities
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the PRO-ergo
end of the treatment as part of usual care (average of 6 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Exercise capacity
Periodo de tiempo: baseline (T0) as part of usual care
6 Minute Walk Test (6MWT)
baseline (T0) as part of usual care
Exercise capacity
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
6 Minute Walk Test (6MWT)
end of the treatment as part of usual care (average of 6 months)
Exercise capacity
Periodo de tiempo: baseline (T0) as part of usual care
Short Physical Performance Battery (SPPB)
baseline (T0) as part of usual care
Exercise capacity
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
Short Physical Performance Battery (SPPB)
end of the treatment as part of usual care (average of 6 months)
Quadriceps strength
Periodo de tiempo: baseline (T0) as part of usual care
with a hand dynamometer.
baseline (T0) as part of usual care
Quadriceps strength
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
with a hand dynamometer.
end of the treatment as part of usual care (average of 6 months)
Hand grip strength
Periodo de tiempo: baseline (T0) as part of usual care
with a hand dynamometer.
baseline (T0) as part of usual care
Hand grip strength
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
with a hand dynamometer.
end of the treatment as part of usual care (average of 6 months)
Bioimpedance (BIA
Periodo de tiempo: baseline (T0) as part of usual care
baseline (T0) as part of usual care
Bioimpedance (BIA
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
end of the treatment as part of usual care (average of 6 months)
VAS-appetite, taste and smell
Periodo de tiempo: baseline (T0) as part of usual care
baseline (T0) as part of usual care
VAS-appetite, taste and smell
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
end of the treatment as part of usual care (average of 6 months)
Dietary goal attainment
Periodo de tiempo: baseline (T0) as part of usual care
baseline (T0) as part of usual care
Dietary goal attainment
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
end of the treatment as part of usual care (average of 6 months)
Liquid medical nutrition
Periodo de tiempo: baseline (T0) as part of usual care
baseline (T0) as part of usual care
Liquid medical nutrition
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
end of the treatment as part of usual care (average of 6 months)
Sarcopenia
Periodo de tiempo: baseline (T0) as part of usual care
measured with the SARC-F
baseline (T0) as part of usual care
Sarcopenia
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the SARC-F
end of the treatment as part of usual care (average of 6 months)
Types of Stool
Periodo de tiempo: baseline (T0) as part of usual care
measured with the Bristol Stool Chart (BCS)
baseline (T0) as part of usual care
Types of Stool
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the Bristol Stool Chart (BCS)
end of the treatment as part of usual care (average of 6 months)
Voice Problems
Periodo de tiempo: baseline (T0) as part of usual care
measured with Maximum Phonation Time (MPT)
baseline (T0) as part of usual care
Voice Problems
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with Maximum Phonation Time (MPT)
end of the treatment as part of usual care (average of 6 months)
Swallowing Problems
Periodo de tiempo: baseline (T0) as part of usual care
measured with Maximum Swallowing Speed (MSP)
baseline (T0) as part of usual care
Swallowing Problems
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with Maximum Swallowing Speed (MSP)
end of the treatment as part of usual care (average of 6 months)
Physical Functioning
Periodo de tiempo: baseline (T0) as part of usual care
measured with the Assessment of Motor and Process Skills (AMPS)
baseline (T0) as part of usual care
Physical Functioning
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the Assessment of Motor and Process Skills (AMPS)
end of the treatment as part of usual care (average of 6 months)
Cognitive Functioning
Periodo de tiempo: baseline (T0) as part of usual care
measured with the Cognitive Complaints - Participation (CoCo-P)
baseline (T0) as part of usual care
Cognitive Functioning
Periodo de tiempo: end of the treatment as part of usual care (average of 6 months)
measured with the Cognitive Complaints - Participation (CoCo-P)
end of the treatment as part of usual care (average of 6 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Philip van der Wees, Prof. dr., Radboud University Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de marzo de 2021

Finalización primaria (Anticipado)

17 de julio de 2022

Finalización del estudio (Anticipado)

1 de enero de 2024

Fechas de registro del estudio

Enviado por primera vez

28 de enero de 2021

Primero enviado que cumplió con los criterios de control de calidad

2 de febrero de 2021

Publicado por primera vez (Actual)

3 de febrero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

9 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • ParaCOV

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .