Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients: An Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Body Constitution Scores using Body Constitution Questionnaires Assessment
研究概览
简要总结
According to the ongoing observational studies and the Chinese Medicine practice guideline for COVID-19 patients, the discharged patients with COVID-19 still exhibits certain clinical symptoms such as fatigue, poor appetite, short of breath, palpation, and poor sleep, which could be recognized as two main Patterns in Chinese Medicine, Qi Deficiency of Lung and Spleen and Qi & Yin Deficiency. Based on this, pulmonary rehabilitation to improve lung function upon discharged was proposed. Therefore, even patients with COVID-19 were discharged from hospitals, there are symptoms with significant clinical syndromes in Chinese Medicine perspectives. These symptoms, in terms of syndrome, which could link with the body constitutions, could be due to pre-COVID-19 infection, suffering from infection, or a consequence of post-infection.
This observational study is a rehabilitation programme to elucidate i) whether body constitution is linking with the infection of COVID-19; ii) whether TCM can help the recovery of discharged COVID-19 patients.
详细描述
This is an observational multi-centered study that will be conducted in the government subsidized tri-partite CM out-patient clinics (Chinese Medicine Clinic cum Training and Research Centres, "CMCTRs").
The study contains two parts as follows:
- Retrospective Syndrome Survey: Retrospective information will be collected from participants using semi-structured interview and measuring the baseline body constitution before the rehabilitation treatment under the Programme, with the self-developed Body Constitutions Questionnaire.
- TCM therapeutic assessment: The improvement of clinical symptoms and the status of body constitutions will be periodically evaluated.
Clinical CM Diagnostic Pattern & clinical characteristics assessments, lung function tests, quality of life and no. of western medical consultations will be assessed at each visit for 9 months. Both retrospective and prospective assessments will be done for those participants who have already joined the Rehabilitation Program in CMCTRs.
Sample Size: Estimated at 150 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants under the COVID-19 Rehabilitation Program who have been previously diagnosed to be infected with COVID-19 and discharged from local hospitals after treatment with western medicine, with negative results from COVID-19 virus detection.
排除标准
- •Participants will be excluded if they have one or more of the followings: 1) inability to communicate (e.g. cognitive impairment); 2) history of CHM allergies; 3) incompetent in giving consent.
结局指标
主要结局
Change in Body Constitution Scores using Body Constitution Questionnaires Assessment
时间窗: Change from Baseline the Body Constitution at 9 months
The changes in participants' health as characterized by body constitution scores using the Body Constitution Questionnaires for the nine specific types of body constitutions will be assessed on each visit during the treatment and follow up period.
Change in CM Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment
时间窗: Change from Baseline the CM Diagnostic Pattern & Clinical Characteristics at 9 months
The changes in participants' health as characterized by CM diagnostic pattern \& clinical characteristics using CM Syndrome Differentiation according to the Guidelines for Chinese Medicine New Drug Clinical Study (China Medical Science Press, 2002) will be assessed on each visit during the treatment and follow up period.
次要结局
- SpO2 in 6-minute Walk Test (6MWT)(9 months)
- Blood Pressure in 6-minute Walk Test (6MWT)(9 months)
- Assessment on Western Medicine Visit Frequency(9 months)
- Force Vital Capacity (FVC) in Spirometry Assessment(9 months)
- Distance Walked in 6-minute Walk Test (6MWT)(9 months)
- Peak Expiratory Flow (PEF) in Spirometry Assessment(9 months)
- Lung Function Questionnaire in Lung Function Assessment(9 months)
- Pulse in 6-minute Walk Test (6MWT)(9 months)
- Forced Expiratory Volume in 1 second (FEV1) in Spirometry Assessment(9 months)
- FEV1/FVC ratio (%) in Spirometry Assessment(9 months)
- Quality of Life (WHO-QOL BREF HK)(9 months)
- Number of Rests in 6-minute Walk Test (6MWT)(9 months)
- MRC Dyspnoea Scale in 6-minute Walk Test (6MWT)(9 months)
- Borg Scale of Perceived Exertion in 6-minute Walk Test (6MWT)(9 months)
研究者
ZhaoXiang Bian
Chair Professor/Director of Clinical Division, SCM
Hong Kong Baptist University