Covid19ParaCOVNCT04735744
Evaluation of Allied Healthcare in Patients Recovering From COVID-19
An observational study of Covid19 and Allied Health Professionals, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Allied Health Professionals, Primary Care
- How many people
- 1,441 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Mar 2021to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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/Handreikingvoordezorg.pdf
Who cannot join
- Adult patients:
- receiving palliative care; are excluded from this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6500HB
About this study
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.
Read more
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.
- Conditions
- Covid19, Allied Health Professionals, Primary Care, Retrospective Cohort, PROMs, Performance Measures
- Being tested
- Patients recovering from COVID19 receive usual care by allied health professionals
- Keywords
- Covid19, Allied health professionals, primary care, PROMs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients recovering from COVID19 receive usual care by allied health professionalsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Patients recovering from COVID19 receive usual care by allied health professionals | |
| 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 Receives: Other: Patients recovering from COVID19 receive usual care by allied health professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Measured: Baseline (T0)
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Measured: 3 months (T1)
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Measured: 6 months (T2)
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Measured: 12 months (T3)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Measured: Baseline (T0)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Measured: 3 months (T1)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Measured: 6 months (T2)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Measured: 12 months (T3)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Measured: Baseline (T0)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Measured: 3 months (T1)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Measured: 6 months (T2)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Measured: 12 months (T3)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Measured: Baseline (T0)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Measured: 3 months (T1)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Measured: 6 months (T2)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Measured: 12 months (T3)
Costs
will be measured using a cost questionnaire (18 items)
Measured: Baseline (T0)
Costs
will be measured using a cost questionnaire (18 items)
Measured: 3 months (T1)
Costs
will be measured using a cost questionnaire (18 items)
Measured: 6 months (T2)
Costs
will be measured using a cost questionnaire (18 items)
Measured: 9 months (T3)
Costs
will be measured using a cost questionnaire (18 items)
Measured: 12 months (T4)
Patient Specific Activities
measured with the Patient Specific Complaints (PSC)
Measured: baseline (T0) as part of usual care
Patient Specific Activities
measured with the Patient Specific Complaints (PSC)
Measured: end of the treatment as part of usual care (average of 6 months)
Nutritional Status
measured with the BMI (weight and height)
Measured: baseline (T0) as part of usual care
Nutritional Status
measured with the BMI (weight and height)
Measured: 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).
Measured: baseline (T0) as part of usual care
Global Assessment
measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
Measured: end of the treatment as part of usual care (average of 6 months)
Voice Problems
measured with Voice Handicap Index (VHI)
Measured: baseline (T0) as part of usual care
Voice Problems
measured with Voice Handicap Index (VHI)
Measured: end of the treatment as part of usual care (average of 6 months)
Swallowing Problems
Dysphagia Handicap Index (DHI).
Measured: baseline (T0) as part of usual care
Swallowing Problems
Dysphagia Handicap Index (DHI).
Measured: end of the treatment as part of usual care (average of 6 months)
Patient Specific Activities
measured with the Canadian Occupational Performance Measure (COPM)
Measured: baseline (T0) as part of usual care
Patient Specific Activities
measured with the Canadian Occupational Performance Measure (COPM)
Measured: end of the treatment as part of usual care (average of 6 months)
Activities
measured with the PRO-ergo
Measured: baseline (T0) as part of usual care
Activities
measured with the PRO-ergo
Measured: end of the treatment as part of usual care (average of 6 months)
Secondary outcomes (28)
Exercise capacity
6 Minute Walk Test (6MWT)
Measured: baseline (T0) as part of usual care
Exercise capacity
6 Minute Walk Test (6MWT)
Measured: end of the treatment as part of usual care (average of 6 months)
Exercise capacity
Short Physical Performance Battery (SPPB)
Measured: baseline (T0) as part of usual care
Exercise capacity
Short Physical Performance Battery (SPPB)
Measured: end of the treatment as part of usual care (average of 6 months)
Quadriceps strength
with a hand dynamometer.
Measured: baseline (T0) as part of usual care
Quadriceps strength
with a hand dynamometer.
Measured: end of the treatment as part of usual care (average of 6 months)
Hand grip strength
with a hand dynamometer.
Measured: baseline (T0) as part of usual care
Hand grip strength
with a hand dynamometer.
Measured: end of the treatment as part of usual care (average of 6 months)
Bioimpedance (BIA
Measured: baseline (T0) as part of usual care
Bioimpedance (BIA
Measured: end of the treatment as part of usual care (average of 6 months)
VAS-appetite, taste and smell
Measured: baseline (T0) as part of usual care
VAS-appetite, taste and smell
Measured: end of the treatment as part of usual care (average of 6 months)
Dietary goal attainment
Measured: baseline (T0) as part of usual care
Dietary goal attainment
Measured: end of the treatment as part of usual care (average of 6 months)
Liquid medical nutrition
Measured: baseline (T0) as part of usual care
Liquid medical nutrition
Measured: end of the treatment as part of usual care (average of 6 months)
Sarcopenia
measured with the SARC-F
Measured: baseline (T0) as part of usual care
Sarcopenia
measured with the SARC-F
Measured: end of the treatment as part of usual care (average of 6 months)
Types of Stool
measured with the Bristol Stool Chart (BCS)
Measured: baseline (T0) as part of usual care
Types of Stool
measured with the Bristol Stool Chart (BCS)
Measured: end of the treatment as part of usual care (average of 6 months)
Voice Problems
measured with Maximum Phonation Time (MPT)
Measured: baseline (T0) as part of usual care
Voice Problems
measured with Maximum Phonation Time (MPT)
Measured: end of the treatment as part of usual care (average of 6 months)
Swallowing Problems
measured with Maximum Swallowing Speed (MSP)
Measured: baseline (T0) as part of usual care
Swallowing Problems
measured with Maximum Swallowing Speed (MSP)
Measured: 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)
Measured: baseline (T0) as part of usual care
Physical Functioning
measured with the Assessment of Motor and Process Skills (AMPS)
Measured: end of the treatment as part of usual care (average of 6 months)
Cognitive Functioning
measured with the Cognitive Complaints - Participation (CoCo-P)
Measured: baseline (T0) as part of usual care
Cognitive Functioning
measured with the Cognitive Complaints - Participation (CoCo-P)
Measured: end of the treatment as part of usual care (average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start29 Mar 2021
- Primary completion17 Jul 2022 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip van der Wees, Prof. dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735744
- Sponsor's protocol ID
- ParaCOV
- Acronym
- ParaCOV
- Status last verified
- May 2022
- First submitted
- 28 Jan 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 42115968Slotegraaf 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.
PubMed 39429046Ben 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.
PubMed 39393926Gerards 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.
PubMed 39173549Slotegraaf 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.
PubMed 38318773Slotegraaf 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.
PubMed 37862083
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Allied Healthcare in Patients Recovering From COVID-19
- ClinicalTrials.gov ID
- NCT04735744
- Acronym / sponsor ID
- ParaCOV / ParaCOV
- Conditions
- Covid19, Allied Health Professionals, Primary Care, Retrospective Cohort, PROMs, Performance Measures
- Keywords
- Covid19, Allied health professionals, primary care, PROMs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,441 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 17 Jul 2022 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Other: Patients recovering from COVID19 receive usual care by allied health professionalsAllied 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 | – | Other: Patients recovering from COVID19 receive usual care by allied health professionalsAllied 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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/Handreikingvoordezorg.pdf
Key exclusion criteria (2 listed)
- receiving palliative care; are excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients recovering from COVID19 receive usual care by allied health professionalsWe 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. | Other | Prospective cohort, Retrospective cohort |
Primary outcome
Participation
Time frame: Baseline (T0)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Participation
Time frame: 3 months (T1)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Participation
Time frame: 6 months (T2)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Participation
Time frame: 12 months (T3)
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Quality of life measured with EQ-5D-5L
Time frame: Baseline (T0)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Quality of life measured with EQ-5D-5L
Time frame: 3 months (T1)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Quality of life measured with EQ-5D-5L
Time frame: 6 months (T2)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Quality of life measured with EQ-5D-5L
Time frame: 12 months (T3)
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Fatigue
Time frame: Baseline (T0)
Measured with the Fatigue Severity Scale (FSS)
Fatigue
Time frame: 3 months (T1)
Measured with the Fatigue Severity Scale (FSS)
Fatigue
Time frame: 6 months (T2)
Measured with the Fatigue Severity Scale (FSS)
Fatigue
Time frame: 12 months (T3)
Measured with the Fatigue Severity Scale (FSS)
Physical functioning
Time frame: Baseline (T0)
PROMIS Physical Functioning Short Form 10b (10 items).
Physical functioning
Time frame: 3 months (T1)
PROMIS Physical Functioning Short Form 10b (10 items).
Physical functioning
Time frame: 6 months (T2)
PROMIS Physical Functioning Short Form 10b (10 items).
Physical functioning
Time frame: 12 months (T3)
PROMIS Physical Functioning Short Form 10b (10 items).
Costs
Time frame: Baseline (T0)
will be measured using a cost questionnaire (18 items)
Costs
Time frame: 3 months (T1)
will be measured using a cost questionnaire (18 items)
Costs
Time frame: 6 months (T2)
will be measured using a cost questionnaire (18 items)
Costs
Time frame: 9 months (T3)
will be measured using a cost questionnaire (18 items)
Costs
Time frame: 12 months (T4)
will be measured using a cost questionnaire (18 items)
Patient Specific Activities
Time frame: baseline (T0) as part of usual care
measured with the Patient Specific Complaints (PSC)
Patient Specific Activities
Time frame: end of the treatment as part of usual care (average of 6 months)
measured with the Patient Specific Complaints (PSC)
Nutritional Status
Time frame: baseline (T0) as part of usual care
measured with the BMI (weight and height)
Nutritional Status
Time frame: end of the treatment as part of usual care (average of 6 months)
measured with the BMI (weight and height)
Global Assessment
Time frame: baseline (T0) as part of usual care
measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
Global Assessment
Time frame: 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).
Voice Problems
Time frame: baseline (T0) as part of usual care
measured with Voice Handicap Index (VHI)
Voice Problems
Time frame: end of the treatment as part of usual care (average of 6 months)
measured with Voice Handicap Index (VHI)
Swallowing Problems
Time frame: baseline (T0) as part of usual care
Dysphagia Handicap Index (DHI).
Swallowing Problems
Time frame: end of the treatment as part of usual care (average of 6 months)
Dysphagia Handicap Index (DHI).
Patient Specific Activities
Time frame: baseline (T0) as part of usual care
measured with the Canadian Occupational Performance Measure (COPM)
Patient Specific Activities
Time frame: end of the treatment as part of usual care (average of 6 months)
measured with the Canadian Occupational Performance Measure (COPM)
Activities
Time frame: baseline (T0) as part of usual care
measured with the PRO-ergo
Activities
Time frame: end of the treatment as part of usual care (average of 6 months)
measured with the PRO-ergo
28 secondary outcomes
Exercise capacity
Time frame: baseline (T0) as part of usual care
Exercise capacity
Time frame: end of the treatment as part of usual care (average of 6 months)
Exercise capacity
Time frame: baseline (T0) as part of usual care
Exercise capacity
Time frame: end of the treatment as part of usual care (average of 6 months)
Quadriceps strength
Time frame: baseline (T0) as part of usual care
Quadriceps strength
Time frame: end of the treatment as part of usual care (average of 6 months)
Hand grip strength
Time frame: baseline (T0) as part of usual care
Hand grip strength
Time frame: end of the treatment as part of usual care (average of 6 months)
Bioimpedance (BIA
Time frame: baseline (T0) as part of usual care
Bioimpedance (BIA
Time frame: end of the treatment as part of usual care (average of 6 months)
VAS-appetite, taste and smell
Time frame: baseline (T0) as part of usual care
VAS-appetite, taste and smell
Time frame: end of the treatment as part of usual care (average of 6 months)
Dietary goal attainment
Time frame: baseline (T0) as part of usual care
Dietary goal attainment
Time frame: end of the treatment as part of usual care (average of 6 months)
Liquid medical nutrition
Time frame: baseline (T0) as part of usual care
Liquid medical nutrition
Time frame: end of the treatment as part of usual care (average of 6 months)
Sarcopenia
Time frame: baseline (T0) as part of usual care
Sarcopenia
Time frame: end of the treatment as part of usual care (average of 6 months)
Types of Stool
Time frame: baseline (T0) as part of usual care
Types of Stool
Time frame: end of the treatment as part of usual care (average of 6 months)
Voice Problems
Time frame: baseline (T0) as part of usual care
Voice Problems
Time frame: end of the treatment as part of usual care (average of 6 months)
Swallowing Problems
Time frame: baseline (T0) as part of usual care
Swallowing Problems
Time frame: end of the treatment as part of usual care (average of 6 months)
Physical Functioning
Time frame: baseline (T0) as part of usual care
Physical Functioning
Time frame: end of the treatment as part of usual care (average of 6 months)
Cognitive Functioning
Time frame: baseline (T0) as part of usual care
Cognitive Functioning
Time frame: end of the treatment as part of usual care (average of 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 42115968Cup 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.
- Derived from this study: PubMed 39429046Slotegraaf 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.
- Derived from this study: PubMed 39393926Ben 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.
- Derived from this study: PubMed 39173549Gerards 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.
- Derived from this study: PubMed 38318773Slotegraaf 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.
- Derived from this study: PubMed 37862083Slotegraaf 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip van der Wees, Prof. dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Allied Health Professionals, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation (time frame: Baseline (T0)). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735744, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.