Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients recovering from COVID19 receive usual care by allied health professionals | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation | Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items) | Baseline (T0) |
| Participation | Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items) | 3 months (T1) |
| Participation | Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items) | 6 months (T2) |
| Participation | 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 | Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items) | Baseline (T0) |
| Quality of life measured with EQ-5D-5L | Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items) | 3 months (T1) |
| Quality of life measured with EQ-5D-5L | Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items) | 6 months (T2) |
| Quality of life measured with EQ-5D-5L |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | 6 Minute Walk Test (6MWT) | baseline (T0) as part of usual care |
| Exercise capacity | 6 Minute Walk Test (6MWT) | end of the treatment as part of usual care (average of 6 months) |
Not provided
Inclusion Criteria:
Adult patients
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.
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip van der Wees, Prof. dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Nijmegen | Gelderland | 6500HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42115968 | Derived | Cup EHC, Gerards MHG, Slotegraaf AI, Verburg AC, Hoogeboom TJ, Miedema HS. Work ability and work limitations in people recovering from COVID-19: one-year follow-up cohort results. BMC Public Health. 2026 May 12;26(1):2063. doi: 10.1186/s12889-026-26894-4. | |
| 39429046 | Derived | Slotegraaf AI, Kruizenga HM, Gerards MHG, Verburg AC, Hoogeboom TJ, de van der Schueren MAE; Dutch Consortium Allied Healthcare COVID-19. Risk of poor nutritional status and nutrition-related complaints in individuals attending a primary care dietitian after a COVID-19 infection: A prospective cohort study. Nutr Diet. 2025 Apr;82(2):172-185. doi: 10.1111/1747-0080.12905. Epub 2024 Oct 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
| 12 months (T3) |
| Fatigue | Measured with the Fatigue Severity Scale (FSS) | Baseline (T0) |
| Fatigue | Measured with the Fatigue Severity Scale (FSS) | 3 months (T1) |
| Fatigue | Measured with the Fatigue Severity Scale (FSS) | 6 months (T2) |
| Fatigue | Measured with the Fatigue Severity Scale (FSS) | 12 months (T3) |
| Physical functioning | PROMIS Physical Functioning Short Form 10b (10 items). | Baseline (T0) |
| Physical functioning | PROMIS Physical Functioning Short Form 10b (10 items). | 3 months (T1) |
| Physical functioning | PROMIS Physical Functioning Short Form 10b (10 items). | 6 months (T2) |
| Physical functioning | PROMIS Physical Functioning Short Form 10b (10 items). | 12 months (T3) |
| Costs | will be measured using a cost questionnaire (18 items) | Baseline (T0) |
| Costs | will be measured using a cost questionnaire (18 items) | 3 months (T1) |
| Costs | will be measured using a cost questionnaire (18 items) | 6 months (T2) |
| Costs | will be measured using a cost questionnaire (18 items) | 9 months (T3) |
| Costs | will be measured using a cost questionnaire (18 items) | 12 months (T4) |
| Patient Specific Activities | measured with the Patient Specific Complaints (PSC) | baseline (T0) as part of usual care |
| Patient Specific Activities | measured with the Patient Specific Complaints (PSC) | end of the treatment as part of usual care (average of 6 months) |
| Nutritional Status | measured with the BMI (weight and height) | baseline (T0) as part of usual care |
| Nutritional Status | measured with the BMI (weight and height) | end of the treatment as part of usual care (average of 6 months) |
| Global Assessment | measured with the PG-SGA short form weight history, food intake, symptoms, activities and function). | baseline (T0) as part of usual care |
| Global Assessment | 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 | measured with Voice Handicap Index (VHI) | baseline (T0) as part of usual care |
| Voice Problems | measured with Voice Handicap Index (VHI) | end of the treatment as part of usual care (average of 6 months) |
| Swallowing Problems | Dysphagia Handicap Index (DHI). | baseline (T0) as part of usual care |
| Swallowing Problems | Dysphagia Handicap Index (DHI). | end of the treatment as part of usual care (average of 6 months) |
| Patient Specific Activities | measured with the Canadian Occupational Performance Measure (COPM) | baseline (T0) as part of usual care |
| Patient Specific Activities | measured with the Canadian Occupational Performance Measure (COPM) | end of the treatment as part of usual care (average of 6 months) |
| Activities | measured with the PRO-ergo | baseline (T0) as part of usual care |
| Activities | measured with the PRO-ergo | end of the treatment as part of usual care (average of 6 months) |
| Exercise capacity | Short Physical Performance Battery (SPPB) | baseline (T0) as part of usual care |
| Exercise capacity | Short Physical Performance Battery (SPPB) | end of the treatment as part of usual care (average of 6 months) |
| Quadriceps strength | with a hand dynamometer. | baseline (T0) as part of usual care |
| Quadriceps strength | with a hand dynamometer. | end of the treatment as part of usual care (average of 6 months) |
| Hand grip strength | with a hand dynamometer. | baseline (T0) as part of usual care |
| Hand grip strength | with a hand dynamometer. | end of the treatment as part of usual care (average of 6 months) |
| Bioimpedance (BIA | baseline (T0) as part of usual care |
| Bioimpedance (BIA | end of the treatment as part of usual care (average of 6 months) |
| VAS-appetite, taste and smell | baseline (T0) as part of usual care |
| VAS-appetite, taste and smell | end of the treatment as part of usual care (average of 6 months) |
| Dietary goal attainment | baseline (T0) as part of usual care |
| Dietary goal attainment | end of the treatment as part of usual care (average of 6 months) |
| Liquid medical nutrition | baseline (T0) as part of usual care |
| Liquid medical nutrition | end of the treatment as part of usual care (average of 6 months) |
| Sarcopenia | measured with the SARC-F | baseline (T0) as part of usual care |
| Sarcopenia | measured with the SARC-F | end of the treatment as part of usual care (average of 6 months) |
| Types of Stool | measured with the Bristol Stool Chart (BCS) | baseline (T0) as part of usual care |
| Types of Stool | measured with the Bristol Stool Chart (BCS) | end of the treatment as part of usual care (average of 6 months) |
| Voice Problems | measured with Maximum Phonation Time (MPT) | baseline (T0) as part of usual care |
| Voice Problems | measured with Maximum Phonation Time (MPT) | end of the treatment as part of usual care (average of 6 months) |
| Swallowing Problems | measured with Maximum Swallowing Speed (MSP) | baseline (T0) as part of usual care |
| Swallowing Problems | measured with Maximum Swallowing Speed (MSP) | end of the treatment as part of usual care (average of 6 months) |
| Physical Functioning | measured with the Assessment of Motor and Process Skills (AMPS) | baseline (T0) as part of usual care |
| Physical Functioning | 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 | measured with the Cognitive Complaints - Participation (CoCo-P) | baseline (T0) as part of usual care |
| Cognitive Functioning | measured with the Cognitive Complaints - Participation (CoCo-P) | end of the treatment as part of usual care (average of 6 months) |
| 39393926 | Derived | Ben AJ, Verburg AC, Maas ET, Hoogeboom TJ, Gerards MHG, Slotegraaf AI, Cup EHC, Schaafsma F, W J G Ostelo R, van Dongen JM; Dutch Consortium Allied Healthcare COVID-19, ParaCOV cohort study. Work Trajectories of Patients With Persistent Complaints After a COVID-19 Infection Receiving Allied Healthcare in the Netherlands: A Secondary Analysis of the ParaCOV Cohort. J Occup Environ Med. 2024 Dec 1;66(12):993-999. doi: 10.1097/JOM.0000000000003240. Epub 2024 Oct 10. |
| 39173549 | Derived | Gerards MHG, Slotegraaf AI, Verburg AC, Kruizenga HM, Cup EHC, Kalf JG, Lenssen AF, Meijer WM, Ben AJ, van Dongen JM, de van der Schueren MAE, Graff MJL, Akkermans RP, van der Wees PJ, Hoogeboom TJ; Dutch Consortium Allied Healthcare COVID-19. One-year evaluation of people recovering from COVID-19 receiving allied primary healthcare: A nationwide prospective cohort study. Ann Phys Rehabil Med. 2024 Oct;67(7):101874. doi: 10.1016/j.rehab.2024.101874. Epub 2024 Aug 21. |
| 38318773 | Derived | Slotegraaf AI, de Kruif AJTCM, Agasi-Idenburg CS, van Oers SMD, Ronteltap A, Veenhof C, Gerards MHG, Verburg AC, Hoogeboom TJ, de van der Schueren MAE; Dutch Consortium Allied Healthcare COVID-19. Understanding recovery of people recovering from COVID-19 receiving treatment from primary care allied health professionals: a mixed-methods study. Disabil Rehabil. 2024 Dec;46(24):5798-5807. doi: 10.1080/09638288.2024.2311330. Epub 2024 Feb 6. |
| 37862083 | Derived | Slotegraaf AI, Gerards MHG, Verburg AC, de van der Schueren MAE, Kruizenga HM, Graff MJL, Cup EHC, Kalf JG, Lenssen AF, Meijer WM, Kool RA, de Bie RA, van der Wees PJ, Hoogeboom TJ; Dutch Consortium Allied Healthcare COVID-19. Evaluation of Primary Allied Health Care in Patients Recovering From COVID-19 at 6-Month Follow-up: Dutch Nationwide Prospective Cohort Study. JMIR Public Health Surveill. 2023 Oct 20;9:e44155. doi: 10.2196/44155. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided