Clinical trial NCT04735744: Evaluation of Allied Healthcare in Patients Recovering From COVID-19
Official title: Evaluation of Allied Healthcare in Patients Recovering From COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Allied Health Professionals
Primary Care
Retrospective Cohort
PROMs
Performance Measures
Prospective Cohort
National Dutch Program
Keywords: Covid19
Allied health professionals
primary care
PROMs
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 1441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participation
timeFrame: Baseline (T0)
measure: Participation
timeFrame: 3 months (T1)
measure: Participation
timeFrame: 6 months (T2)
measure: Participation
timeFrame: 12 months (T3)
measure: Quality of life measured with EQ-5D-5L
timeFrame: Baseline (T0)
measure: Quality of life measured with EQ-5D-5L
timeFrame: 3 months (T1)
measure: Quality of life measured with EQ-5D-5L
timeFrame: 6 months (T2)
measure: Quality of life measured with EQ-5D-5L
timeFrame: 12 months (T3)
measure: Fatigue
timeFrame: Baseline (T0)
measure: Fatigue
timeFrame: 3 months (T1)
measure: Fatigue
timeFrame: 6 months (T2)
measure: Fatigue
timeFrame: 12 months (T3)
measure: Physical functioning
timeFrame: Baseline (T0)
measure: Physical functioning
timeFrame: 3 months (T1)
measure: Physical functioning
timeFrame: 6 months (T2)
measure: Physical functioning
timeFrame: 12 months (T3)
measure: Costs
timeFrame: Baseline (T0)
measure: Costs
timeFrame: 3 months (T1)
measure: Costs
timeFrame: 6 months (T2)
measure: Costs
timeFrame: 9 months (T3)
measure: Costs
timeFrame: 12 months (T4)
measure: Patient Specific Activities
timeFrame: baseline (T0) as part of usual care
measure: Patient Specific Activities
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Nutritional Status
timeFrame: baseline (T0) as part of usual care
measure: Nutritional Status
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Global Assessment
timeFrame: baseline (T0) as part of usual care
measure: Global Assessment
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Voice Problems
timeFrame: baseline (T0) as part of usual care
measure: Voice Problems
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Swallowing Problems
timeFrame: baseline (T0) as part of usual care
measure: Swallowing Problems
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Patient Specific Activities
timeFrame: baseline (T0) as part of usual care
measure: Patient Specific Activities
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Activities
timeFrame: baseline (T0) as part of usual care
measure: Activities
timeFrame: end of the treatment as part of usual care (average of 6 months)
Secondary outcomes:
measure: Exercise capacity
timeFrame: baseline (T0) as part of usual care
measure: Exercise capacity
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Exercise capacity
timeFrame: baseline (T0) as part of usual care
measure: Exercise capacity
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Quadriceps strength
timeFrame: baseline (T0) as part of usual care
measure: Quadriceps strength
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Hand grip strength
timeFrame: baseline (T0) as part of usual care
measure: Hand grip strength
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Bioimpedance (BIA
timeFrame: baseline (T0) as part of usual care
measure: Bioimpedance (BIA
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: VAS-appetite, taste and smell
timeFrame: baseline (T0) as part of usual care
measure: VAS-appetite, taste and smell
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Dietary goal attainment
timeFrame: baseline (T0) as part of usual care
measure: Dietary goal attainment
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Liquid medical nutrition
timeFrame: baseline (T0) as part of usual care
measure: Liquid medical nutrition
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Sarcopenia
timeFrame: baseline (T0) as part of usual care
measure: Sarcopenia
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Types of Stool
timeFrame: baseline (T0) as part of usual care
measure: Types of Stool
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Voice Problems
timeFrame: baseline (T0) as part of usual care
measure: Voice Problems
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Swallowing Problems
timeFrame: baseline (T0) as part of usual care
measure: Swallowing Problems
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Physical Functioning
timeFrame: baseline (T0) as part of usual care
measure: Physical Functioning
timeFrame: end of the treatment as part of usual care (average of 6 months)
measure: Cognitive Functioning
timeFrame: baseline (T0) as part of usual care
measure: Cognitive Functioning
timeFrame: end of the treatment as part of usual care (average of 6 months)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Philip van der Wees, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: