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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04735744
Other study ID # ParaCOV
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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)
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