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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Gelderland
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Nijmegen、Gelderland、オランダ、6500HB
- Radboud University Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participation
時間枠：Baseline (T0)
|
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
時間枠：3 months (T1)
|
Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)
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3 months (T1)
|
|
Participation
時間枠：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)
|
|
Participation
時間枠：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
時間枠：Baseline (T0)
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Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
Baseline (T0)
|
|
Quality of life measured with EQ-5D-5L
時間枠：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
時間枠：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
時間枠：12 months (T3)
|
Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)
|
12 months (T3)
|
|
Fatigue
時間枠：Baseline (T0)
|
Measured with the Fatigue Severity Scale (FSS)
|
Baseline (T0)
|
|
Fatigue
時間枠：3 months (T1)
|
Measured with the Fatigue Severity Scale (FSS)
|
3 months (T1)
|
|
Fatigue
時間枠：6 months (T2)
|
Measured with the Fatigue Severity Scale (FSS)
|
6 months (T2)
|
|
Fatigue
時間枠：12 months (T3)
|
Measured with the Fatigue Severity Scale (FSS)
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12 months (T3)
|
|
Physical functioning
時間枠：Baseline (T0)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
Baseline (T0)
|
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Physical functioning
時間枠：3 months (T1)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
3 months (T1)
|
|
Physical functioning
時間枠：6 months (T2)
|
PROMIS Physical Functioning Short Form 10b (10 items).
|
6 months (T2)
|
|
Physical functioning
時間枠：12 months (T3)
|
PROMIS Physical Functioning Short Form 10b (10 items).
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12 months (T3)
|
|
Costs
時間枠：Baseline (T0)
|
will be measured using a cost questionnaire (18 items)
|
Baseline (T0)
|
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Costs
時間枠：3 months (T1)
|
will be measured using a cost questionnaire (18 items)
|
3 months (T1)
|
|
Costs
時間枠：6 months (T2)
|
will be measured using a cost questionnaire (18 items)
|
6 months (T2)
|
|
Costs
時間枠：9 months (T3)
|
will be measured using a cost questionnaire (18 items)
|
9 months (T3)
|
|
Costs
時間枠：12 months (T4)
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will be measured using a cost questionnaire (18 items)
|
12 months (T4)
|
|
Patient Specific Activities
時間枠：baseline (T0) as part of usual care
|
measured with the Patient Specific Complaints (PSC)
|
baseline (T0) as part of usual care
|
|
Patient Specific Activities
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with the BMI (weight and height)
|
baseline (T0) as part of usual care
|
|
Nutritional Status
時間枠：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
時間枠：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
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with Voice Handicap Index (VHI)
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baseline (T0) as part of usual care
|
|
Voice Problems
時間枠：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
時間枠：baseline (T0) as part of usual care
|
Dysphagia Handicap Index (DHI).
|
baseline (T0) as part of usual care
|
|
Swallowing Problems
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with the Canadian Occupational Performance Measure (COPM)
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baseline (T0) as part of usual care
|
|
Patient Specific Activities
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with the PRO-ergo
|
baseline (T0) as part of usual care
|
|
Activities
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exercise capacity
時間枠：baseline (T0) as part of usual care
|
6 Minute Walk Test (6MWT)
|
baseline (T0) as part of usual care
|
|
Exercise capacity
時間枠：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
時間枠：baseline (T0) as part of usual care
|
Short Physical Performance Battery (SPPB)
|
baseline (T0) as part of usual care
|
|
Exercise capacity
時間枠：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
時間枠：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
時間枠：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
時間枠：baseline (T0) as part of usual care
|
with a hand dynamometer.
|
baseline (T0) as part of usual care
|
|
Hand grip strength
時間枠：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
時間枠：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Bioimpedance (BIA
時間枠：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
時間枠：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
VAS-appetite, taste and smell
時間枠：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
時間枠：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
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Dietary goal attainment
時間枠：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
時間枠：baseline (T0) as part of usual care
|
baseline (T0) as part of usual care
|
|
|
Liquid medical nutrition
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with the SARC-F
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baseline (T0) as part of usual care
|
|
Sarcopenia
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with the Bristol Stool Chart (BCS)
|
baseline (T0) as part of usual care
|
|
Types of Stool
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with Maximum Phonation Time (MPT)
|
baseline (T0) as part of usual care
|
|
Voice Problems
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with Maximum Swallowing Speed (MSP)
|
baseline (T0) as part of usual care
|
|
Swallowing Problems
時間枠：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
時間枠：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
時間枠：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
時間枠：baseline (T0) as part of usual care
|
measured with the Cognitive Complaints - Participation (CoCo-P)
|
baseline (T0) as part of usual care
|
|
Cognitive Functioning
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Philip van der Wees, Prof. dr.、Radboud University Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ParaCOV
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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