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.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Gelderland
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Nijmegen, Gelderland, 네덜란드, 6500HB
- Radboud University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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
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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.
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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
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participation
기간: Baseline (T0)
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Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
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Baseline (T0)
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Participation
기간: 3 months (T1)
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Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
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3 months (T1)
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Participation
기간: 6 months (T2)
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Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
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6 months (T2)
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Participation
기간: 12 months (T3)
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Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
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12 months (T3)
|
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Quality of life measured with EQ-5D-5L
기간: Baseline (T0)
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Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
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Baseline (T0)
|
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Quality of life measured with EQ-5D-5L
기간: 3 months (T1)
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Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
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3 months (T1)
|
|
Quality of life measured with EQ-5D-5L
기간: 6 months (T2)
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Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
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6 months (T2)
|
|
Quality of life measured with EQ-5D-5L
기간: 12 months (T3)
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Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
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12 months (T3)
|
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Fatigue
기간: Baseline (T0)
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Measured with the Fatigue Severity Scale (FSS)
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Baseline (T0)
|
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Fatigue
기간: 3 months (T1)
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Measured with the Fatigue Severity Scale (FSS)
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3 months (T1)
|
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Fatigue
기간: 6 months (T2)
|
Measured with the Fatigue Severity Scale (FSS)
|
6 months (T2)
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Fatigue
기간: 12 months (T3)
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Measured with the Fatigue Severity Scale (FSS)
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12 months (T3)
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Physical functioning
기간: Baseline (T0)
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PROMIS Physical Functioning Short Form 10b (10 items).
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Baseline (T0)
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Physical functioning
기간: 3 months (T1)
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PROMIS Physical Functioning Short Form 10b (10 items).
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3 months (T1)
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|
Physical functioning
기간: 6 months (T2)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
6 months (T2)
|
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Physical functioning
기간: 12 months (T3)
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PROMIS Physical Functioning Short Form 10b (10 items).
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12 months (T3)
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Costs
기간: Baseline (T0)
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will be measured using a cost questionnaire (18 items)
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Baseline (T0)
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Costs
기간: 3 months (T1)
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will be measured using a cost questionnaire (18 items)
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3 months (T1)
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Costs
기간: 6 months (T2)
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will be measured using a cost questionnaire (18 items)
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6 months (T2)
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Costs
기간: 9 months (T3)
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will be measured using a cost questionnaire (18 items)
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9 months (T3)
|
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Costs
기간: 12 months (T4)
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will be measured using a cost questionnaire (18 items)
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12 months (T4)
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Patient Specific Activities
기간: baseline (T0) as part of usual care
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measured with the Patient Specific Complaints (PSC)
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baseline (T0) as part of usual care
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Patient Specific Activities
기간: end of the treatment as part of usual care (average of 6 months)
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measured with the Patient Specific Complaints (PSC)
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end of the treatment as part of usual care (average of 6 months)
|
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Nutritional Status
기간: baseline (T0) as part of usual care
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measured with the BMI (weight and height)
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baseline (T0) as part of usual care
|
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Nutritional Status
기간: end of the treatment as part of usual care (average of 6 months)
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measured with the BMI (weight and height)
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end of the treatment as part of usual care (average of 6 months)
|
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Global Assessment
기간: baseline (T0) as part of usual care
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measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
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baseline (T0) as part of usual care
|
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Global Assessment
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
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end of the treatment as part of usual care (average of 6 months)
|
|
Voice Problems
기간: baseline (T0) as part of usual care
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measured with Voice Handicap Index (VHI)
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baseline (T0) as part of usual care
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Voice Problems
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with Voice Handicap Index (VHI)
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end of the treatment as part of usual care (average of 6 months)
|
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Swallowing Problems
기간: baseline (T0) as part of usual care
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Dysphagia Handicap Index (DHI).
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baseline (T0) as part of usual care
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Swallowing Problems
기간: end of the treatment as part of usual care (average of 6 months)
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Dysphagia Handicap Index (DHI).
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end of the treatment as part of usual care (average of 6 months)
|
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Patient Specific Activities
기간: baseline (T0) as part of usual care
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measured with the Canadian Occupational Performance Measure (COPM)
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baseline (T0) as part of usual care
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Patient Specific Activities
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with the Canadian Occupational Performance Measure (COPM)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Activities
기간: baseline (T0) as part of usual care
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measured with the PRO-ergo
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baseline (T0) as part of usual care
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Activities
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with the PRO-ergo
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end of the treatment as part of usual care (average of 6 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exercise capacity
기간: baseline (T0) as part of usual care
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6 Minute Walk Test (6MWT)
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baseline (T0) as part of usual care
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Exercise capacity
기간: end of the treatment as part of usual care (average of 6 months)
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6 Minute Walk Test (6MWT)
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end of the treatment as part of usual care (average of 6 months)
|
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Exercise capacity
기간: baseline (T0) as part of usual care
|
Short Physical Performance Battery (SPPB)
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baseline (T0) as part of usual care
|
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Exercise capacity
기간: end of the treatment as part of usual care (average of 6 months)
|
Short Physical Performance Battery (SPPB)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Quadriceps strength
기간: baseline (T0) as part of usual care
|
with a hand dynamometer.
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baseline (T0) as part of usual care
|
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Quadriceps strength
기간: end of the treatment as part of usual care (average of 6 months)
|
with a hand dynamometer.
|
end of the treatment as part of usual care (average of 6 months)
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Hand grip strength
기간: baseline (T0) as part of usual care
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with a hand dynamometer.
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baseline (T0) as part of usual care
|
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Hand grip strength
기간: end of the treatment as part of usual care (average of 6 months)
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with a hand dynamometer.
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end of the treatment as part of usual care (average of 6 months)
|
|
Bioimpedance (BIA
기간: baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
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Bioimpedance (BIA
기간: end of the treatment as part of usual care (average of 6 months)
|
end of the treatment as part of usual care (average of 6 months)
|
|
|
VAS-appetite, taste and smell
기간: baseline (T0) as part of usual care
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baseline (T0) as part of usual care
|
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VAS-appetite, taste and smell
기간: end of the treatment as part of usual care (average of 6 months)
|
end of the treatment as part of usual care (average of 6 months)
|
|
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Dietary goal attainment
기간: baseline (T0) as part of usual care
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baseline (T0) as part of usual care
|
|
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Dietary goal attainment
기간: end of the treatment as part of usual care (average of 6 months)
|
end of the treatment as part of usual care (average of 6 months)
|
|
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Liquid medical nutrition
기간: baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Liquid medical nutrition
기간: end of the treatment as part of usual care (average of 6 months)
|
end of the treatment as part of usual care (average of 6 months)
|
|
|
Sarcopenia
기간: baseline (T0) as part of usual care
|
measured with the SARC-F
|
baseline (T0) as part of usual care
|
|
Sarcopenia
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with the SARC-F
|
end of the treatment as part of usual care (average of 6 months)
|
|
Types of Stool
기간: baseline (T0) as part of usual care
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measured with the Bristol Stool Chart (BCS)
|
baseline (T0) as part of usual care
|
|
Types of Stool
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with the Bristol Stool Chart (BCS)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Voice Problems
기간: baseline (T0) as part of usual care
|
measured with Maximum Phonation Time (MPT)
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baseline (T0) as part of usual care
|
|
Voice Problems
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with Maximum Phonation Time (MPT)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Swallowing Problems
기간: baseline (T0) as part of usual care
|
measured with Maximum Swallowing Speed (MSP)
|
baseline (T0) as part of usual care
|
|
Swallowing Problems
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with Maximum Swallowing Speed (MSP)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Physical Functioning
기간: baseline (T0) as part of usual care
|
measured with the Assessment of Motor and Process Skills (AMPS)
|
baseline (T0) as part of usual care
|
|
Physical Functioning
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with the Assessment of Motor and Process Skills (AMPS)
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end of the treatment as part of usual care (average of 6 months)
|
|
Cognitive Functioning
기간: baseline (T0) as part of usual care
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measured with the Cognitive Complaints - Participation (CoCo-P)
|
baseline (T0) as part of usual care
|
|
Cognitive Functioning
기간: end of the treatment as part of usual care (average of 6 months)
|
measured with the Cognitive Complaints - Participation (CoCo-P)
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end of the treatment as part of usual care (average of 6 months)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Philip van der Wees, Prof. dr., Radboud University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ParaCOV
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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