Evaluation of Allied Healthcare in Patients Recovering From COVID-19

Covid19 Clinical Trial

— ParaCOV  

Official title:

Evaluation of Allied Healthcare in Patients Recovering From COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04735744
• Other study ID #: ParaCOV
• Status: Active, not recruiting
• Start date: March 29, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1441
• Est. completion date: January 1, 2024
• Est. primary completion date: July 17, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allied Health Professionals
• COVID-19
• Covid19
• National Dutch Program
• Performance Measures
• Primary Care
• PROMs
• Prospective Cohort
• Retrospective Cohort

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation	Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)	Baseline (T0)
Primary	Participation	Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)	3 months (T1)
Primary	Participation	Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)	6 months (T2)
Primary	Participation	Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)	12 months (T3)
Primary	Quality of life measured with EQ-5D-5L	Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)	Baseline (T0)
Primary	Quality of life measured with EQ-5D-5L	Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)	3 months (T1)
Primary	Quality of life measured with EQ-5D-5L	Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)	6 months (T2)
Primary	Quality of life measured with EQ-5D-5L	Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)	12 months (T3)
Primary	Fatigue	Measured with the Fatigue Severity Scale (FSS)	Baseline (T0)
Primary	Fatigue	Measured with the Fatigue Severity Scale (FSS)	3 months (T1)
Primary	Fatigue	Measured with the Fatigue Severity Scale (FSS)	6 months (T2)
Primary	Fatigue	Measured with the Fatigue Severity Scale (FSS)	12 months (T3)
Primary	Physical functioning	PROMIS Physical Functioning Short Form 10b (10 items).	Baseline (T0)
Primary	Physical functioning	PROMIS Physical Functioning Short Form 10b (10 items).	3 months (T1)
Primary	Physical functioning	PROMIS Physical Functioning Short Form 10b (10 items).	6 months (T2)
Primary	Physical functioning	PROMIS Physical Functioning Short Form 10b (10 items).	12 months (T3)
Primary	Costs	will be measured using a cost questionnaire (18 items)	Baseline (T0)
Primary	Costs	will be measured using a cost questionnaire (18 items)	3 months (T1)
Primary	Costs	will be measured using a cost questionnaire (18 items)	6 months (T2)
Primary	Costs	will be measured using a cost questionnaire (18 items)	9 months (T3)
Primary	Costs	will be measured using a cost questionnaire (18 items)	12 months (T4)
Primary	Patient Specific Activities	measured with the Patient Specific Complaints (PSC)	baseline (T0) as part of usual care
Primary	Patient Specific Activities	measured with the Patient Specific Complaints (PSC)	end of the treatment as part of usual care (average of 6 months)
Primary	Nutritional Status	measured with the BMI (weight and height)	baseline (T0) as part of usual care
Primary	Nutritional Status	measured with the BMI (weight and height)	end of the treatment as part of usual care (average of 6 months)
Primary	Global Assessment	measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).	baseline (T0) as part of usual care
Primary	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)
Primary	Voice Problems	measured with Voice Handicap Index (VHI)	baseline (T0) as part of usual care
Primary	Voice Problems	measured with Voice Handicap Index (VHI)	end of the treatment as part of usual care (average of 6 months)
Primary	Swallowing Problems	Dysphagia Handicap Index (DHI).	baseline (T0) as part of usual care
Primary	Swallowing Problems	Dysphagia Handicap Index (DHI).	end of the treatment as part of usual care (average of 6 months)
Primary	Patient Specific Activities	measured with the Canadian Occupational Performance Measure (COPM)	baseline (T0) as part of usual care
Primary	Patient Specific Activities	measured with the Canadian Occupational Performance Measure (COPM)	end of the treatment as part of usual care (average of 6 months)
Primary	Activities	measured with the PRO-ergo	baseline (T0) as part of usual care
Primary	Activities	measured with the PRO-ergo	end of the treatment as part of usual care (average of 6 months)
Secondary	Exercise capacity	6 Minute Walk Test (6MWT)	baseline (T0) as part of usual care
Secondary	Exercise capacity	6 Minute Walk Test (6MWT)	end of the treatment as part of usual care (average of 6 months)
Secondary	Exercise capacity	Short Physical Performance Battery (SPPB)	baseline (T0) as part of usual care
Secondary	Exercise capacity	Short Physical Performance Battery (SPPB)	end of the treatment as part of usual care (average of 6 months)
Secondary	Quadriceps strength	with a hand dynamometer.	baseline (T0) as part of usual care
Secondary	Quadriceps strength	with a hand dynamometer.	end of the treatment as part of usual care (average of 6 months)
Secondary	Hand grip strength	with a hand dynamometer.	baseline (T0) as part of usual care
Secondary	Hand grip strength	with a hand dynamometer.	end of the treatment as part of usual care (average of 6 months)
Secondary	Bioimpedance (BIA		baseline (T0) as part of usual care
Secondary	Bioimpedance (BIA		end of the treatment as part of usual care (average of 6 months)
Secondary	VAS-appetite, taste and smell		baseline (T0) as part of usual care
Secondary	VAS-appetite, taste and smell		end of the treatment as part of usual care (average of 6 months)
Secondary	Dietary goal attainment		baseline (T0) as part of usual care
Secondary	Dietary goal attainment		end of the treatment as part of usual care (average of 6 months)
Secondary	Liquid medical nutrition		baseline (T0) as part of usual care
Secondary	Liquid medical nutrition		end of the treatment as part of usual care (average of 6 months)
Secondary	Sarcopenia	measured with the SARC-F	baseline (T0) as part of usual care
Secondary	Sarcopenia	measured with the SARC-F	end of the treatment as part of usual care (average of 6 months)
Secondary	Types of Stool	measured with the Bristol Stool Chart (BCS)	baseline (T0) as part of usual care
Secondary	Types of Stool	measured with the Bristol Stool Chart (BCS)	end of the treatment as part of usual care (average of 6 months)
Secondary	Voice Problems	measured with Maximum Phonation Time (MPT)	baseline (T0) as part of usual care
Secondary	Voice Problems	measured with Maximum Phonation Time (MPT)	end of the treatment as part of usual care (average of 6 months)
Secondary	Swallowing Problems	measured with Maximum Swallowing Speed (MSP)	baseline (T0) as part of usual care
Secondary	Swallowing Problems	measured with Maximum Swallowing Speed (MSP)	end of the treatment as part of usual care (average of 6 months)
Secondary	Physical Functioning	measured with the Assessment of Motor and Process Skills (AMPS)	baseline (T0) as part of usual care
Secondary	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)
Secondary	Cognitive Functioning	measured with the Cognitive Complaints - Participation (CoCo-P)	baseline (T0) as part of usual care
Secondary	Cognitive Functioning	measured with the Cognitive Complaints - Participation (CoCo-P)	end of the treatment as part of usual care (average of 6 months)