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.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
Gelderland
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Nijmegen、Gelderland、荷兰、6500HB
- Radboud University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participation
大体时间：Baseline (T0)
|
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
|
Baseline (T0)
|
|
Participation
大体时间：3 months (T1)
|
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
|
3 months (T1)
|
|
Participation
大体时间：6 months (T2)
|
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
|
6 months (T2)
|
|
Participation
大体时间：12 months (T3)
|
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
大体时间：Baseline (T0)
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
Baseline (T0)
|
|
Quality of life measured with EQ-5D-5L
大体时间：3 months (T1)
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
3 months (T1)
|
|
Quality of life measured with EQ-5D-5L
大体时间：6 months (T2)
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
6 months (T2)
|
|
Quality of life measured with EQ-5D-5L
大体时间：12 months (T3)
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
12 months (T3)
|
|
Fatigue
大体时间：Baseline (T0)
|
Measured with the Fatigue Severity Scale (FSS)
|
Baseline (T0)
|
|
Fatigue
大体时间：3 months (T1)
|
Measured with the Fatigue Severity Scale (FSS)
|
3 months (T1)
|
|
Fatigue
大体时间：6 months (T2)
|
Measured with the Fatigue Severity Scale (FSS)
|
6 months (T2)
|
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Fatigue
大体时间：12 months (T3)
|
Measured with the Fatigue Severity Scale (FSS)
|
12 months (T3)
|
|
Physical functioning
大体时间：Baseline (T0)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
Baseline (T0)
|
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Physical functioning
大体时间：3 months (T1)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
3 months (T1)
|
|
Physical functioning
大体时间：6 months (T2)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
6 months (T2)
|
|
Physical functioning
大体时间：12 months (T3)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
12 months (T3)
|
|
Costs
大体时间：Baseline (T0)
|
will be measured using a cost questionnaire (18 items)
|
Baseline (T0)
|
|
Costs
大体时间：3 months (T1)
|
will be measured using a cost questionnaire (18 items)
|
3 months (T1)
|
|
Costs
大体时间：6 months (T2)
|
will be measured using a cost questionnaire (18 items)
|
6 months (T2)
|
|
Costs
大体时间：9 months (T3)
|
will be measured using a cost questionnaire (18 items)
|
9 months (T3)
|
|
Costs
大体时间：12 months (T4)
|
will be measured using a cost questionnaire (18 items)
|
12 months (T4)
|
|
Patient Specific Activities
大体时间：baseline (T0) as part of usual care
|
measured with the Patient Specific Complaints (PSC)
|
baseline (T0) as part of usual care
|
|
Patient Specific Activities
大体时间：end of the treatment as part of usual care (average of 6 months)
|
measured with the Patient Specific Complaints (PSC)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Nutritional Status
大体时间：baseline (T0) as part of usual care
|
measured with the BMI (weight and height)
|
baseline (T0) as part of usual care
|
|
Nutritional Status
大体时间：end of the treatment as part of usual care (average of 6 months)
|
measured with the BMI (weight and height)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Global Assessment
大体时间：baseline (T0) as part of usual care
|
measured with the PG-SGA short form weight history, food intake, symptoms, activities and function).
|
baseline (T0) as part of usual care
|
|
Global Assessment
大体时间：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).
|
end of the treatment as part of usual care (average of 6 months)
|
|
Voice Problems
大体时间：baseline (T0) as part of usual care
|
measured with Voice Handicap Index (VHI)
|
baseline (T0) as part of usual care
|
|
Voice Problems
大体时间：end of the treatment as part of usual care (average of 6 months)
|
measured with Voice Handicap Index (VHI)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Swallowing Problems
大体时间：baseline (T0) as part of usual care
|
Dysphagia Handicap Index (DHI).
|
baseline (T0) as part of usual care
|
|
Swallowing Problems
大体时间：end of the treatment as part of usual care (average of 6 months)
|
Dysphagia Handicap Index (DHI).
|
end of the treatment as part of usual care (average of 6 months)
|
|
Patient Specific Activities
大体时间：baseline (T0) as part of usual care
|
measured with the Canadian Occupational Performance Measure (COPM)
|
baseline (T0) as part of usual care
|
|
Patient Specific Activities
大体时间：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
大体时间：baseline (T0) as part of usual care
|
measured with the PRO-ergo
|
baseline (T0) as part of usual care
|
|
Activities
大体时间：end of the treatment as part of usual care (average of 6 months)
|
measured with the PRO-ergo
|
end of the treatment as part of usual care (average of 6 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise capacity
大体时间：baseline (T0) as part of usual care
|
6 Minute Walk Test (6MWT)
|
baseline (T0) as part of usual care
|
|
Exercise capacity
大体时间：end of the treatment as part of usual care (average of 6 months)
|
6 Minute Walk Test (6MWT)
|
end of the treatment as part of usual care (average of 6 months)
|
|
Exercise capacity
大体时间：baseline (T0) as part of usual care
|
Short Physical Performance Battery (SPPB)
|
baseline (T0) as part of usual care
|
|
Exercise capacity
大体时间：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
大体时间：baseline (T0) as part of usual care
|
with a hand dynamometer.
|
baseline (T0) as part of usual care
|
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Quadriceps strength
大体时间：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)
|
|
Hand grip strength
大体时间：baseline (T0) as part of usual care
|
with a hand dynamometer.
|
baseline (T0) as part of usual care
|
|
Hand grip strength
大体时间：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)
|
|
Bioimpedance (BIA
大体时间：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Bioimpedance (BIA
大体时间：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
大体时间：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
VAS-appetite, taste and smell
大体时间：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)
|
|
|
Dietary goal attainment
大体时间：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Dietary goal attainment
大体时间：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)
|
|
|
Liquid medical nutrition
大体时间：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Liquid medical nutrition
大体时间：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
大体时间：baseline (T0) as part of usual care
|
measured with the SARC-F
|
baseline (T0) as part of usual care
|
|
Sarcopenia
大体时间：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
大体时间：baseline (T0) as part of usual care
|
measured with the Bristol Stool Chart (BCS)
|
baseline (T0) as part of usual care
|
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Types of Stool
大体时间：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
大体时间：baseline (T0) as part of usual care
|
measured with Maximum Phonation Time (MPT)
|
baseline (T0) as part of usual care
|
|
Voice Problems
大体时间：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
大体时间：baseline (T0) as part of usual care
|
measured with Maximum Swallowing Speed (MSP)
|
baseline (T0) as part of usual care
|
|
Swallowing Problems
大体时间：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
大体时间：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
大体时间：end of the treatment as part of usual care (average of 6 months)
|
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
大体时间：baseline (T0) as part of usual care
|
measured with the Cognitive Complaints - Participation (CoCo-P)
|
baseline (T0) as part of usual care
|
|
Cognitive Functioning
大体时间：end of the treatment as part of usual care (average of 6 months)
|
measured with the Cognitive Complaints - Participation (CoCo-P)
|
end of the treatment as part of usual care (average of 6 months)
|
合作者和调查者
调查人员
- 首席研究员：Philip van der Wees, Prof. dr.、Radboud University Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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