Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients With Long COVID: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Patient activation measure 13
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme with monitoring via a mobile app produces medium-term improvements in self-management, fatigue and quality of life in patients affected by persistent COVID.
The main questions it aims to answer are:
- Will a multimodal program (exercise with education) improve the self-management ability of patients with post-exertional malaise?
- Does fatigue and quality of life will be improved in these patients?
Researchers will compare an experimental breath program to a control standard care group to see if multimodal program works to treat post-exertion malaise.
Participants will:
- Follow-up 12 weeks online sessions:
1 weekly synchronous online session + 1 scheduled asynchronous session + educational resources
- Daily use of the app: daily log, education and questions
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post COVID-19 condition: individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction
- •Between 18 and 75 years of age
- •Possibility of access and use of smartphone.
- •Ability to attend the clinic in person for an initial session.
排除标准
- •Patients with a history of respiratory or cardiovascular diseases prior to COVID-19, other acute or chronic diseases that may interfere with the study
- •Pregnancy/breastfeeding
- •Those with contraindications to respiratory muscle training.
研究组 & 干预措施
Control
Usual care
干预措施: Usual Care (Other)
Telerehabilitation program
The interventions include:
- Education for self-management
- Personalised exercise program
结局指标
主要结局
Patient activation measure 13
时间窗: From enrollment to end of treatment and 3 months follow-up
Individual's knowledge, skills and confidence to managing one's own health. is a non-disease-specific tool and can be used across different patient populations. The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate a greater patient activation. PAM-13 scores can then be categorized into four stages of activation, corresponding to the difficulty of the PAM-13 items: level 1 (patients believe active role is important; items 1-2), level 2 (patients have confidence and knowledge to take action; items 3-8), level 3 (taking action; items 9-11) and level 4 (staying on course under stress; items 12-13).
self-care self-efficacy scale
时间窗: From enrollment to end of treatment and 3 months follow-up
Measure for self-care self-efficacy for chronic illness. This 10-item instrument measures self-efficacy related to self-care maintenance, monitoring, and management in patients with chronic illness. Each item is rated on a '1-5' rating scale, with a higher score representing a higher level of self-efficacy. Scale scores are standardized mathematically to range from 0-100.
次要结局
- Health-related quality of life EuroQol-5D(From enrollment to end of treatment and 3 months follow-up)
- Fatigue Severity Scale (FSS)(From enrollment to end of treatment and 3 months follow-up)
- DePaul Symptom Questionnaire-Short Form (DSQ-SF)(From enrollment to end of treatment and 3 months follow-up)
- Semi-structured interview: Satisfaction and experience with the tele-rehabilitation program(From the end of treatment to 4 weeks)