OutreAch MediCal Care for HousEbound Patients With Post-COVID-19 Syndrome or ME/CFS of Any Cause
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
The significance of the Post-COVID Syndrome (PCS) has been widely acknowledged. Various efforts are made to find out about the pathomechanisms behind PCS and to establish therapies. One sub-group of PCS-patients, however, is generally excluded from any studies, and that are those who are unable to visit outpatient clinics or hospitals for diagnostic work up or participation in clinical trials, as they are unable to leave their home and to seek medical support on their own physical and mental capabilities. They are housebound, mostly or totally bedridden. Similar cases are known from myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) of any cause and are graded as moderate to very severe ME/CFS according to the Canadian Consensus criteria. The patients are usually seen by their family doctor and have no access to medical specialists.
The planned project aims to find out about the prevalence of this most severe manifestation of PCS, the clinical characteristics, the prevalence of mimics, risk factors and impact of the disease on the patients' life and their family/caregivers. Individual care and treatment plans will be developed and the effect of monthly consultation hours for patients and caregivers upon the patients' health status and the caregiver burden will be evaluated in a randomized controlled trial. The project will be performed in close cooperation between patients, caregivers, the patient's family doctor and a board of experts from internal medicine, neurology, psychosomatic medicine and general medicine at Hannover Medical School.
We expect an improvement of the patients' and caregivers wellbeing with intensified medical care. We are aware, however, that intensification of the patient-doctor interaction carries the risk to exacerbate the patients' symptoms. The results of our study will show how current models of care for PCS and ME/CFS patients should be modified to fit to the individual patient's aims and capacities.
详细描述
Based on own clinical experience the grant applicants notice a deficit in the current medical care for patients with Post-COVID Syndrome as well as patients with ME/CFS of other causes, who are unable to leave their home -some of them even bedridden - due to extreme fatigue and exhaustibility. Therefore, we developed a multi-disciplinary project focussed on the as-sessment of prevalence and special needs of this patient group, that - in case of a positive evaluation - can easily be transferred into routine medical care.
The planned project aims are:
- to characterize the main clinical symptoms of the extreme PCS or ME/CFS variant
- via standardized anamnesis and physical and mental assessment by specialists in internal medicine, neurology and psychosomatic medicine performed at separate home visits of the patients. In addition to the patients also the caregivers will be interviewed in standardized manner regarding symptom onset and development.
- Patients will be recruited via their family doctors, patient support groups and social media as well as through our Post-COVID outpatient clinics through calls we get from housebound patients and their caretakers.
- to detect and describe PCS/ME/CFS mimics in this group of patients
- via the analysis of all data achieved from home visits as well as the available data of former diagnostic efforts in cooperation with the responsible family doctor.
- Our structured care at Outreach Medical Care for ME/CFS patients includes a thorough evaluation of previous medical findings, where available. Findings that were made years before the onset of symptoms may also be relevant. These findings are recorded in a structured form and are included in the evaluation. Since the electronic health record shall be compiled for every member of a statutory health insurance until January 2025 previous medical findings should be more easily available than currently.
- to identify possible risk factors for the development of the extreme PCS or ME/CFS variant
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ME/CFS according to the Canadian Consensus Criteria
- •Bell Score ≤ 30
- •Duration of the postexertional malaise (PEM) > 14 hours
- •Age > 18 years and < 70
排除标准
- •- Pre-existing conditions or comorbidities that have (or could have) led to a restriction of mobility or mental capacity, such as various diseases of the central nervous system.
研究者
Dirks, Meike Dr.
Consultant, Department of Neurology, Principal Investigator
Hannover Medical School