Skip to content

Evaluation of Allied Healthcare in Patients Recovering From COVID-19

Evaluation of Allied Healthcare in Patients Recovering From COVID-19

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04735744
Acronym
ParaCOV
Enrollment
1441
Registered
2021-02-03
Start date
2021-03-29
Completion date
2024-01-01
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allied Health Professionals, Covid19, National Dutch Program, Performance Measures, Primary Care, PROMs, Prospective Cohort, Retrospective Cohort

Keywords

Covid19, Allied health professionals, primary care, PROMs

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.

Interventions

OTHERPatients 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.

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
FatigueBaseline (T0)Measured with the Fatigue Severity Scale (FSS)
Physical functioningBaseline (T0)PROMIS Physical Functioning Short Form 10b (10 items).
Quality of life measured with EQ-5D-5LBaseline (T0)Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
ParticipationBaseline (T0)Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
CostsBaseline (T0)will be measured using a cost questionnaire (18 items)
Patient Specific Activitiesbaseline (T0) as part of usual caremeasured with the Patient Specific Complaints (PSC)
Nutritional Statusbaseline (T0) as part of usual caremeasured with the BMI (weight and height)
Global Assessmentbaseline (T0) as part of usual caremeasured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
Voice Problemsbaseline (T0) as part of usual caremeasured with Voice Handicap Index (VHI)
Swallowing Problemsbaseline (T0) as part of usual careDysphagia Handicap Index (DHI).
Activitiesbaseline (T0) as part of usual caremeasured with the PRO-ergo

Secondary

MeasureTime frameDescription
Swallowing Problemsbaseline (T0) as part of usual caremeasured with Maximum Swallowing Speed (MSP)
Physical Functioningbaseline (T0) as part of usual caremeasured with the Assessment of Motor and Process Skills (AMPS)
Cognitive Functioningbaseline (T0) as part of usual caremeasured with the Cognitive Complaints - Participation (CoCo-P)
Exercise capacitybaseline (T0) as part of usual care6 Minute Walk Test (6MWT)
Quadriceps strengthbaseline (T0) as part of usual carewith a hand dynamometer.
Hand grip strengthbaseline (T0) as part of usual carewith a hand dynamometer.
Bioimpedance (BIAbaseline (T0) as part of usual care
VAS-appetite, taste and smellbaseline (T0) as part of usual care
Dietary goal attainmentbaseline (T0) as part of usual care
Liquid medical nutritionbaseline (T0) as part of usual care
Sarcopeniabaseline (T0) as part of usual caremeasured with the SARC-F
Types of Stoolbaseline (T0) as part of usual caremeasured with the Bristol Stool Chart (BCS)
Voice Problemsbaseline (T0) as part of usual caremeasured with Maximum Phonation Time (MPT)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026