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 Type
OBSERVATIONAL
Enrollment
1,441
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.
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Time frame: Baseline (T0)
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Time frame: 3 months (T1)
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Time frame: 6 months (T2)
Participation
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
Time frame: 12 months (T3)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Time frame: Baseline (T0)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Time frame: 3 months (T1)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Time frame: 6 months (T2)
Quality of life measured with EQ-5D-5L
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
Time frame: 12 months (T3)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Time frame: Baseline (T0)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Time frame: 3 months (T1)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Time frame: 6 months (T2)
Fatigue
Measured with the Fatigue Severity Scale (FSS)
Time frame: 12 months (T3)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Time frame: Baseline (T0)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Time frame: 3 months (T1)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Time frame: 6 months (T2)
Physical functioning
PROMIS Physical Functioning Short Form 10b (10 items).
Time frame: 12 months (T3)
Costs
will be measured using a cost questionnaire (18 items)
Time frame: Baseline (T0)
Costs
will be measured using a cost questionnaire (18 items)
Time frame: 3 months (T1)
Costs
will be measured using a cost questionnaire (18 items)
Time frame: 6 months (T2)
Costs
will be measured using a cost questionnaire (18 items)
Time frame: 9 months (T3)
Costs
will be measured using a cost questionnaire (18 items)
Time frame: 12 months (T4)
Patient Specific Activities
measured with the Patient Specific Complaints (PSC)
Time frame: baseline (T0) as part of usual care
Patient Specific Activities
measured with the Patient Specific Complaints (PSC)
Time frame: end of the treatment as part of usual care (average of 6 months)
Nutritional Status
measured with the BMI (weight and height)
Time frame: baseline (T0) as part of usual care
Nutritional Status
measured with the BMI (weight and height)
Time frame: 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).
Time frame: baseline (T0) as part of usual care
Global Assessment
measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
Time frame: end of the treatment as part of usual care (average of 6 months)
Voice Problems
measured with Voice Handicap Index (VHI)
Time frame: baseline (T0) as part of usual care
Voice Problems
measured with Voice Handicap Index (VHI)
Time frame: end of the treatment as part of usual care (average of 6 months)
Swallowing Problems
Dysphagia Handicap Index (DHI).
Time frame: baseline (T0) as part of usual care
Swallowing Problems
Dysphagia Handicap Index (DHI).
Time frame: end of the treatment as part of usual care (average of 6 months)
Patient Specific Activities
measured with the Canadian Occupational Performance Measure (COPM)
Time frame: baseline (T0) as part of usual care
Patient Specific Activities
measured with the Canadian Occupational Performance Measure (COPM)
Time frame: end of the treatment as part of usual care (average of 6 months)
Activities
measured with the PRO-ergo
Time frame: baseline (T0) as part of usual care
Activities
measured with the PRO-ergo
Time frame: end of the treatment as part of usual care (average of 6 months)
Exercise capacity
6 Minute Walk Test (6MWT)
Time frame: baseline (T0) as part of usual care
Exercise capacity
6 Minute Walk Test (6MWT)
Time frame: end of the treatment as part of usual care (average of 6 months)
Exercise capacity
Short Physical Performance Battery (SPPB)
Time frame: baseline (T0) as part of usual care
Exercise capacity
Short Physical Performance Battery (SPPB)
Time frame: end of the treatment as part of usual care (average of 6 months)
Quadriceps strength
with a hand dynamometer.
Time frame: baseline (T0) as part of usual care
Quadriceps strength
with a hand dynamometer.
Time frame: end of the treatment as part of usual care (average of 6 months)
Hand grip strength
with a hand dynamometer.
Time frame: baseline (T0) as part of usual care
Hand grip strength
with a hand dynamometer.
Time frame: end of the treatment as part of usual care (average of 6 months)
Bioimpedance (BIA
Time frame: baseline (T0) as part of usual care
Bioimpedance (BIA
Time frame: end of the treatment as part of usual care (average of 6 months)
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VAS-appetite, taste and smell
Time frame: baseline (T0) as part of usual care
VAS-appetite, taste and smell
Time frame: end of the treatment as part of usual care (average of 6 months)
Dietary goal attainment
Time frame: baseline (T0) as part of usual care
Dietary goal attainment
Time frame: end of the treatment as part of usual care (average of 6 months)
Liquid medical nutrition
Time frame: baseline (T0) as part of usual care
Liquid medical nutrition
Time frame: end of the treatment as part of usual care (average of 6 months)
Sarcopenia
measured with the SARC-F
Time frame: baseline (T0) as part of usual care
Sarcopenia
measured with the SARC-F
Time frame: end of the treatment as part of usual care (average of 6 months)
Types of Stool
measured with the Bristol Stool Chart (BCS)
Time frame: baseline (T0) as part of usual care
Types of Stool
measured with the Bristol Stool Chart (BCS)
Time frame: end of the treatment as part of usual care (average of 6 months)
Voice Problems
measured with Maximum Phonation Time (MPT)
Time frame: baseline (T0) as part of usual care
Voice Problems
measured with Maximum Phonation Time (MPT)
Time frame: end of the treatment as part of usual care (average of 6 months)
Swallowing Problems
measured with Maximum Swallowing Speed (MSP)
Time frame: baseline (T0) as part of usual care
Swallowing Problems
measured with Maximum Swallowing Speed (MSP)
Time frame: 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)
Time frame: baseline (T0) as part of usual care
Physical Functioning
measured with the Assessment of Motor and Process Skills (AMPS)
Time frame: end of the treatment as part of usual care (average of 6 months)
Cognitive Functioning
measured with the Cognitive Complaints - Participation (CoCo-P)
Time frame: baseline (T0) as part of usual care
Cognitive Functioning
measured with the Cognitive Complaints - Participation (CoCo-P)
Time frame: end of the treatment as part of usual care (average of 6 months)