NCT06004362招募中不适用
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Short Form 36 (SF-36), Physical Functioning Scale
研究概览
简要总结
The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiological sub-studies in a mixed-methods design.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or SARS-CoV-2 antibodies)
- •History of chronic fatigue (after SARS-CoV-2 infection)
- •At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance, headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia
- •Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full exercise capacity) physical exercise capacity of max. 6 points ("What is your physical exercise capacity on average over the last 7 days?")
- •Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points
- •Patient are technically equipped enough to participate in the online intervention and willing to follow the study procedure to perform the online intervention at home
排除标准
- •Fatigue already present before SARS-CoV-2 infection
- •Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7 OR 8 with yes AND >14h condition worsening)
- •Other underlying conditions leading to symptoms of chronic fatigue, such as unstable mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse
- •Other serious underlying medical conditions, such as severe pulmonary, cardiac, psychiatric, or infectious diseases that could interfere with study participation or affect results • Ongoing opioid therapy or opioid therapy in the week prior to study entry
- •Regular use of cannabinoids or other illicit drugs in the month prior to or during the study
- •Restarting or discontinuing psychotherapy during study participation in the 6 weeks prior to study entry
- •Pregnancy or breastfeeding
- •Participation in another clinical intervention study during study participation 1
- •Regular use of Complementary and Integrative Medicine self-help measures (e.g. meditation, Kneipp hydrotherapiy, etc.) within the study period
- •Current pension procedure or planned claiming of a pension procedure due to disability
- •Planned rehabilitation measures during study participation due to post-COVID syndrome
- •Inclusion and exclusion criteria of the sub-study focus group interviews with physicians
- •Inclusion criteria:
- •Family physicians and general practitioners
- •Regular outpatient care of patients with post-covid syndrome
- •Willingness in principle to participate in a 2-hour interview on-site or online
- •Exclusion criteria:
- •No previous care of post-covid patients
研究组 & 干预措施
Complementary and Integrative Medicine online intervention, routine care and book
Experimental
干预措施: Complementary and Integrative Medicine online intervention, routine care and book (Behavioral)
Routine care and book
Active Comparator
干预措施: Routine care and book (Behavioral)
结局指标
主要结局
Short Form 36 (SF-36), Physical Functioning Scale
时间窗: Baseline, 10 weeks
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
次要结局
- DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Chalder Fatigue Scale (CFS)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Quality of life (EQ-5D-5L)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Visual analog scale (VAS) physical strength(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Visual analog scale (VAS) mental strength(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Continuation of the intervention(10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- General Self-Efficacy Scale (GSE, German version: ASKU)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Safety by recording adverse events(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Adherence to the study intervention(Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10)
- Short Form 36 (SF-36)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Visual analog scale (VAS) headache(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Patient Health Questionnaire 9 (PHQ9)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Post-COVID-Syndrom (PCS) Score(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Expectation regarding study intervention(Baseline)
- Perceived Stress Scale (PSS 4)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Satisfaction with the intervention(Week 10)
- Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)(Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 20, week 30, week 40, week 50)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany
研究点 (1)
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