NCT04735744

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,441

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

January 28, 2021

Last Update Submit

May 9, 2022

Conditions

Covid19Allied Health ProfessionalsPrimary CareRetrospective CohortPROMsPerformance MeasuresProspective CohortNational Dutch Program

Keywords

Covid19Allied health professionalsprimary carePROMs

Outcome Measures

Primary Outcomes (35)

  • 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

    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)

Secondary Outcomes (28)

  • Exercise capacity

    baseline (T0) as part of usual care

  • Exercise capacity

    end of the treatment as part of usual care (average of 6 months)

  • Exercise capacity

    baseline (T0) as part of usual care

  • Exercise capacity

    end of the treatment as part of usual care (average of 6 months)

  • Quadriceps strength

    baseline (T0) as part of usual care

  • +23 more secondary outcomes

Study Arms (2)

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

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

Other: Patients recovering from COVID19 receive usual care by allied health professionals

Interventions

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.

Prospective cohortRetrospective cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Adult patients:
  • \- receiving palliative care; are excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 39429046DERIVED

  • 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.

    PMID: 39393926DERIVED

  • 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.

    PMID: 39173549DERIVED

  • 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.

    PMID: 38318773DERIVED

  • 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.

    PMID: 37862083DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Philip van der Wees, Prof. dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 3, 2021

Study Start

March 29, 2021

Primary Completion

July 17, 2022

Study Completion

January 1, 2024

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

NL(1)