Enhancing COVID Rehabilitation With Technology (ECORT): An Open-label, Single Site Randomized Controlled Trial Evaluating the Effectiveness of Electronic Case Management for Individuals With Persistent COVID-19 Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change in WHODAS 2.0 score
研究概览
简要总结
In March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19 since testing began. For many of these patients, symptoms resolve within 4 weeks of onset. However, it is becoming apparent that a significant number of individuals are experiencing symptoms that persist long after the acute infection, known as Long COVID. These individuals have a wide constellation of presenting symptoms, often varying from initial presentation. For this study, we will be enrolling individuals receiving care at The Ottawa Hospital for Long COVID. This study aims to determine the following four things: 1) will adding electronic case management improve quality of life three months after coming to hospital with Long COVID; 2) is the electronic case management platform cost effective; 3) is there any factors that predict outcomes at 3 months; 4) to determine how a personalized rehabilitation program supported by a digital platform could be implemented for individuals with Long COVID. We will enroll individuals from The Ottawa Hospital who will then be randomly assigned to receive either usual care or usual care plus electronic case management, through a platform called NexJ Connected Wellness. Participants will also complete questionnaires every 4 weeks for 3 months. We will be looking at quality of life, mental and physical health, cognitive symptoms, fatigue and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must:
- •Be 18 years of age or older
- •Have a confirmed diagnosis of COVID-19 with a PCR test at least 12 weeks prior OR a confirmed Rapid Antigen Test at least 12-weeks prior OR meet Ottawa Public Health guidance for a suspected COVID-19 case
- •Have at least one ongoing symptom consistent with Long COVID as measured by the WHO Post COVID Case Report Form (CRF)
- •Have a minimum WHODAS (36 item) sum score of 15
- •Be willing to use email for study activities
- •Be able and willing to use a smart phone application for the duration of the trial
- •Be able to read and understand English or French.
- •Be willing and able to provide informed consent.
排除标准
- •Participants must not:
- •Have any significant functional impairment (for example. advanced dementia, heart or lung disease) as judged by the assessing clinician
- •Participate in another long-COVID trial where treatment is required in the protocol (pharmacological or behavioural). Observational studies will be allowed.
- •Have symptoms consistent with Long COVID that are better explained by an alternative diagnosis
研究组 & 干预措施
Usual Care
Assessment. Participants randomized to the control arm will be offered assessment by a clinician, guided by the WHO Post COVID-19 case report form. This is a clinical tool developed by WHO to guide and document the sequelae of COVID-19 and to ensure that clinical and rehabilitation needs are identified.
Investigation. Clinician judgement will be used to decide on further testing needed for clinical care.
Management. Control participants will receive a rehabilitation plan developed with their health professional that will be implemented in the eight weeks after their initial consultation (baseline visit). The implementation will involve face to face or virtual care from a registered health professional provided by the clinic or research staff. This may be a combination of, but not limited to, occupational therapy, physical therapy and/or social work/counselling. The frequency of treatment visits will depend on the individual treatment plan after assessment.
干预措施: Usual Care (Other)
Electronic Case Management plus Usual Care
Participants randomized to the experimental arm will receive assessment, investigation and management as the Active Comparator Arm plus access to an electronic case management platform - NexJ Connected Wellness (https://nexjhealth.com/) which complements the rehabilitation plan. This would include for example setting targets for activity that would be monitored with NexJ; educational materials; and support with medication adherence by reminders. The NexJ platform will include the following sections: Trusted Educational Content (Health Library); Symptom Tracking, Goal Setting, Community Forums and Reporting.
干预措施: NexJ Connected Wellness (Behavioral)
Electronic Case Management plus Usual Care
Participants randomized to the experimental arm will receive assessment, investigation and management as the Active Comparator Arm plus access to an electronic case management platform - NexJ Connected Wellness (https://nexjhealth.com/) which complements the rehabilitation plan. This would include for example setting targets for activity that would be monitored with NexJ; educational materials; and support with medication adherence by reminders. The NexJ platform will include the following sections: Trusted Educational Content (Health Library); Symptom Tracking, Goal Setting, Community Forums and Reporting.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in WHODAS 2.0 score
时间窗: Baseline and Week 12
The WHODAS is the 36-item self report questionnaire measuring health and disability from the previous 30 days across six domains of functioning: cognition, mobility, self-care, getting along, life activities and participation. Responses are scored on a 5 point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme/Cannot Do (4). Change from baseline to week 12 will be measured as primary outcome.
次要结局
- GAD-7(Baseline, Week 4, Week8 and Week 12)
- PSQI(Baseline, Week 4, Week8 and Week 12)
- PHQ-9(Baseline, Week 4, Week8 and Week 12)
- ASSIST(Baseline)
- WHO Post-COVID CRF(Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks.)
- PCL-5(Baseline, Week 4, Week8 and Week 12)
- Fatigue Numeric Rating Scale(Baseline, Week 4, Week8 and Week 12)
- Pain Numeric Rating Scale(Baseline, Week 4, Week8 and Week 12)
- Oral Trail Making Test A and B(Baseline and Week 12)
- EQ-5D-5L(Baseline, Week 4, Week8 and Week 12)
- Hopkins Verbal Learning Test-Revised (HVLT-R)(Baseline and Week 12)
- Fatigue Severity Scale(Baseline, Week 4, Week8 and Week 12)
- Digit Span subset(Baseline and Week 12)
- MRC Dyspnoea Scale(Baseline, Week 4, Week8 and Week 12)
- WEMWBS(Baseline and Week 12)
- Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test)(Baseline and Week 12)
- AUDIT(Baseline)
研究者
Dr. Simon Hatcher
Acting Chair, Department of Psychiatry
University of Ottawa