Evaluation of Allied Healthcare in Patients Recovering From COVID-19 (ParaCOV)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Gelderland
-
Nijmegen, Gelderland, Pays-Bas, 6500HB
- Radboud University Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participation
Délai: Baseline (T0)
|
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
|
Baseline (T0)
|
|
Participation
Délai: 3 months (T1)
|
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
|
3 months (T1)
|
|
Participation
Délai: 6 months (T2)
|
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
|
6 months (T2)
|
|
Participation
Délai: 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
Délai: Baseline (T0)
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
Baseline (T0)
|
|
Quality of life measured with EQ-5D-5L
Délai: 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
Délai: 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
Délai: 12 months (T3)
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
12 months (T3)
|
|
Fatigue
Délai: Baseline (T0)
|
Measured with the Fatigue Severity Scale (FSS)
|
Baseline (T0)
|
|
Fatigue
Délai: 3 months (T1)
|
Measured with the Fatigue Severity Scale (FSS)
|
3 months (T1)
|
|
Fatigue
Délai: 6 months (T2)
|
Measured with the Fatigue Severity Scale (FSS)
|
6 months (T2)
|
|
Fatigue
Délai: 12 months (T3)
|
Measured with the Fatigue Severity Scale (FSS)
|
12 months (T3)
|
|
Physical functioning
Délai: Baseline (T0)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
Baseline (T0)
|
|
Physical functioning
Délai: 3 months (T1)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
3 months (T1)
|
|
Physical functioning
Délai: 6 months (T2)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
6 months (T2)
|
|
Physical functioning
Délai: 12 months (T3)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
12 months (T3)
|
|
Costs
Délai: Baseline (T0)
|
will be measured using a cost questionnaire (18 items)
|
Baseline (T0)
|
|
Costs
Délai: 3 months (T1)
|
will be measured using a cost questionnaire (18 items)
|
3 months (T1)
|
|
Costs
Délai: 6 months (T2)
|
will be measured using a cost questionnaire (18 items)
|
6 months (T2)
|
|
Costs
Délai: 9 months (T3)
|
will be measured using a cost questionnaire (18 items)
|
9 months (T3)
|
|
Costs
Délai: 12 months (T4)
|
will be measured using a cost questionnaire (18 items)
|
12 months (T4)
|
|
Patient Specific Activities
Délai: baseline (T0) as part of usual care
|
measured with the Patient Specific Complaints (PSC)
|
baseline (T0) as part of usual care
|
|
Patient Specific Activities
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with the BMI (weight and height)
|
baseline (T0) as part of usual care
|
|
Nutritional Status
Délai: 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
Délai: 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
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with Voice Handicap Index (VHI)
|
baseline (T0) as part of usual care
|
|
Voice Problems
Délai: 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
Délai: baseline (T0) as part of usual care
|
Dysphagia Handicap Index (DHI).
|
baseline (T0) as part of usual care
|
|
Swallowing Problems
Délai: 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
Délai: 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
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with the PRO-ergo
|
baseline (T0) as part of usual care
|
|
Activities
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Exercise capacity
Délai: baseline (T0) as part of usual care
|
6 Minute Walk Test (6MWT)
|
baseline (T0) as part of usual care
|
|
Exercise capacity
Délai: 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
Délai: baseline (T0) as part of usual care
|
Short Physical Performance Battery (SPPB)
|
baseline (T0) as part of usual care
|
|
Exercise capacity
Délai: 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
Délai: baseline (T0) as part of usual care
|
with a hand dynamometer.
|
baseline (T0) as part of usual care
|
|
Quadriceps strength
Délai: 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
Délai: baseline (T0) as part of usual care
|
with a hand dynamometer.
|
baseline (T0) as part of usual care
|
|
Hand grip strength
Délai: 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
Délai: baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Bioimpedance (BIA
Délai: 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
Délai: baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
VAS-appetite, taste and smell
Délai: 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
Délai: baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Dietary goal attainment
Délai: 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
Délai: baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Liquid medical nutrition
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with the SARC-F
|
baseline (T0) as part of usual care
|
|
Sarcopenia
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with the Bristol Stool Chart (BCS)
|
baseline (T0) as part of usual care
|
|
Types of Stool
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with Maximum Phonation Time (MPT)
|
baseline (T0) as part of usual care
|
|
Voice Problems
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with Maximum Swallowing Speed (MSP)
|
baseline (T0) as part of usual care
|
|
Swallowing Problems
Délai: 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
Délai: 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
Délai: 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
Délai: baseline (T0) as part of usual care
|
measured with the Cognitive Complaints - Participation (CoCo-P)
|
baseline (T0) as part of usual care
|
|
Cognitive Functioning
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Philip van der Wees, Prof. dr., Radboud University Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ParaCOV
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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