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

9 maja 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

1441

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Holandia
    • Gelderland
      • Nijmegen, Gelderland, Holandia, 6500HB
        • Radboud University Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie dotyczy

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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
Inny: Patients recovering from COVID19 receive usual care by allied health professionals
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
Inny: Patients recovering from COVID19 receive usual care by allied health professionals
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Participation
Ramy czasowe: Baseline (T0)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Baseline (T0)
Participation
Ramy czasowe: 3 months (T1)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
3 months (T1)
Participation
Ramy czasowe: 6 months (T2)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
6 months (T2)
Participation
Ramy czasowe: 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
Ramy czasowe: Baseline (T0)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Baseline (T0)
Quality of life measured with EQ-5D-5L
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 12 months (T3)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
12 months (T3)
Fatigue
Ramy czasowe: Baseline (T0)
Measured with the Fatigue Severity Scale (FSS)
Baseline (T0)
Fatigue
Ramy czasowe: 3 months (T1)
Measured with the Fatigue Severity Scale (FSS)
3 months (T1)
Fatigue
Ramy czasowe: 6 months (T2)
Measured with the Fatigue Severity Scale (FSS)
6 months (T2)
Fatigue
Ramy czasowe: 12 months (T3)
Measured with the Fatigue Severity Scale (FSS)
12 months (T3)
Physical functioning
Ramy czasowe: Baseline (T0)
PROMIS Physical Functioning Short Form 10b (10 items).
Baseline (T0)
Physical functioning
Ramy czasowe: 3 months (T1)
PROMIS Physical Functioning Short Form 10b (10 items).
3 months (T1)
Physical functioning
Ramy czasowe: 6 months (T2)
PROMIS Physical Functioning Short Form 10b (10 items).
6 months (T2)
Physical functioning
Ramy czasowe: 12 months (T3)
PROMIS Physical Functioning Short Form 10b (10 items).
12 months (T3)
Costs
Ramy czasowe: Baseline (T0)
will be measured using a cost questionnaire (18 items)
Baseline (T0)
Costs
Ramy czasowe: 3 months (T1)
will be measured using a cost questionnaire (18 items)
3 months (T1)
Costs
Ramy czasowe: 6 months (T2)
will be measured using a cost questionnaire (18 items)
6 months (T2)
Costs
Ramy czasowe: 9 months (T3)
will be measured using a cost questionnaire (18 items)
9 months (T3)
Costs
Ramy czasowe: 12 months (T4)
will be measured using a cost questionnaire (18 items)
12 months (T4)
Patient Specific Activities
Ramy czasowe: baseline (T0) as part of usual care
measured with the Patient Specific Complaints (PSC)
baseline (T0) as part of usual care
Patient Specific Activities
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with the BMI (weight and height)
baseline (T0) as part of usual care
Nutritional Status
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with Voice Handicap Index (VHI)
baseline (T0) as part of usual care
Voice Problems
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
Dysphagia Handicap Index (DHI).
baseline (T0) as part of usual care
Swallowing Problems
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with the PRO-ergo
baseline (T0) as part of usual care
Activities
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Exercise capacity
Ramy czasowe: baseline (T0) as part of usual care
6 Minute Walk Test (6MWT)
baseline (T0) as part of usual care
Exercise capacity
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
Short Physical Performance Battery (SPPB)
baseline (T0) as part of usual care
Exercise capacity
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
with a hand dynamometer.
baseline (T0) as part of usual care
Quadriceps strength
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
with a hand dynamometer.
baseline (T0) as part of usual care
Hand grip strength
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
baseline (T0) as part of usual care
Bioimpedance (BIA
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
baseline (T0) as part of usual care
VAS-appetite, taste and smell
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
baseline (T0) as part of usual care
Dietary goal attainment
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
baseline (T0) as part of usual care
Liquid medical nutrition
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with the SARC-F
baseline (T0) as part of usual care
Sarcopenia
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with the Bristol Stool Chart (BCS)
baseline (T0) as part of usual care
Types of Stool
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with Maximum Phonation Time (MPT)
baseline (T0) as part of usual care
Voice Problems
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with Maximum Swallowing Speed (MSP)
baseline (T0) as part of usual care
Swallowing Problems
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline (T0) as part of usual care
measured with the Cognitive Complaints - Participation (CoCo-P)
baseline (T0) as part of usual care
Cognitive Functioning
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Radboud University Medical Center

Śledczy

  • Główny śledczy: Philip van der Wees, Prof. dr., Radboud University Medical Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 marca 2021

Zakończenie podstawowe (Oczekiwany)

17 lipca 2022

Ukończenie studiów (Oczekiwany)

1 stycznia 2024

Daty rejestracji na studia

Pierwszy przesłany

28 stycznia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lutego 2021

Pierwszy wysłany (Rzeczywisty)

3 lutego 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 maja 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 maja 2022

Ostatnia weryfikacja

1 maja 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ParaCOV

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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