Evaluation of Allied Healthcare in Patients Recovering From COVID-19 (ParaCOV)

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 Overview

• Status: Active, not recruiting
• Conditions: Covid19; PROMs; Primary Care; Performance Measures; Allied Health Professionals; Retrospective Cohort; Prospective Cohort; National Dutch Program
• Intervention / Treatment: Other: Patients recovering from COVID19 receive usual care by allied health professionals

• Study Type: Observational
• Enrollment (Actual): 1441

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Philip van der Wees, Prof. dr., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): July 17, 2022
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Covid19; primary care; PROMs; Allied health professionals
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ParaCOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No