Telemedical Monitoring and Treatment of COPD Patients Associated With General Practice (TEMOKAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- WHO-5 Well-Being Index and 1b: Contacts to healthcare services associated with COPD, 1c: The Readiness and Enablement Index for Health Technology (READHY) questionnaire
研究概览
简要总结
The purpose of this study (The TEMOKAP study) is to investigate whether home-based treatment with telemedicine and support from healthcare professionals can prevent acute exacerbations of COPD and avoid acute hospital admissions, and whether this will improve the participant's health status and quality of life. In other words, the project seeks to document how life with COPD can be made better and safer for all COPD patients.
The project is a collaboration between the University of Copenhagen, alles Lægehus (everyone's medical practice), Epital Health A/S, and Apopro.dk and will be conducted as a scientific study.
详细描述
Why the TEMOKAP Study? The TEMOKAP study represents a new treatment method where, with the help of modern technology and telemedicine, we can offer examination and treatment in your own home if a medical issue or an acute exacerbation of your chronic illness should arise. In a time of Corona, as Denmark is experiencing, this principle is fully in line with the Danish Health Authority's recommendations to protect our chronic patients and reduce the risk of infection.
What are the benefits of participating?
- Direct and easy daily access to medical/healthcare professional help regarding your COPD
- The possibility of receiving treatment in the safe environment of your own home
- Free delivery of medication to your home address, so you don't have to go to the pharmacy yourself
- Reduced risk of infection with the Corona virus and other infectious diseases
- Prevention of exacerbations of your COPD and avoidance of hospital admissions
- Increased co-determination in your own treatment process
- Freedom and security to live better with a chronic illness How does it work? The TEMOKAP study works "proactively", meaning it reacts and acts "before the damage is done". This has become possible through the tele-tools that you will be provided with and use daily to take measurements from home. Your measurements are analyzed daily by mathematical models that can help the TEMOKAP study's doctors and nurses predict exacerbations, so they can initiate treatment much earlier than normal.
As a participant in the TEMOKAP study, in addition to your usual medication, you will have two types of "acute medication" (antibiotics and corticosteroids) readily available at home. This means that our doctors and nurses can initiate treatment immediately if an exacerbation should occur. You avoid a lot of hassle with getting prescriptions and picking up medication at the pharmacy - and most importantly, you save time and can start treatment quickly. TEMOKAP study, participant information (v3) 2 The TEMOKAP study also has a strong focus on your well-being and safety and therefore offers an open emergency line where you can get in touch with qualified healthcare professionals who are always ready if you need help or support in your daily life.
What does participation involve? Initially, you will undergo a clinical examination by a doctor or nurse from the TEMOKAP study with a special focus on your COPD. We will adjust your medication if necessary, and together we will make a plan for your wishes and goals for the future. You will then decide whether you wish to participate in the TEMOKAP study, and if you meet the necessary criteria for participation, you will need to sign a "Consent Form". Once signed, you will be randomly placed in either an "active group" or a "control group".
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 45 years
- •diagnosed with COPD according to the criteria of the GOLD guideline
- •a score of minimum three out of six points in cognitive screening test (The Clock Test + Three-Word Recall Memory Test)
- •must have the ability to provide oral or written informed consent
- •must have access to the internet in their own home
- •must own a smartphone
- •must be able to use simple functions in web browsers.
排除标准
- •unstable heart disease
- •poorly regulated diabetes
- •diagnosed with psychiatric conditions who leads to mental impaired functions
- •unable to communicate in oral and written Danish.
结局指标
主要结局
WHO-5 Well-Being Index and 1b: Contacts to healthcare services associated with COPD, 1c: The Readiness and Enablement Index for Health Technology (READHY) questionnaire
时间窗: From enrollment to the end of treatment at 12 month
Patient's mental well-being was assessed by the WHO-5 Well-Being Index. This is a validated questionnaire that examines patients' mental well-being and can also indicate anxiety, stress, and depression. 1b: Patients' contacts to healthcare services associated with COPD included general practice (GP), out-of-offices services, outpatient clinics and hospital admissions at T0, T1 and T2 in both groups. Baseline information on hospital admissions was also examined retrospectively 12 months from the date of inclusion. Data are only self-reported but were verified by the clinical co-investigators with interviews to ensure that the COPD-related outcomes were accurate. 1c: The Readiness and Enablement Index for Health Technology (READHY) allows for a more systematic assessment of patient readiness for health technology, which includes dimensions of self-management capabilities (including emotional distress), perceived support and digital health literacy. Together with socio-demographic
Patients' contacts to healthcare services associated with COPD
时间窗: From enrollment to the end of treatment at 12 month
Patients' contacts to healthcare services associated with COPD included general practice (GP), out-of-offices services, outpatient clinics and hospital admissions at T0, T1 and T2 in both groups. Baseline information on hospital admissions was also examined retrospectively 12 months from the date of inclusion. Data are only self-reported but were verified by the clinical co-investigators with interviews to ensure that the COPD-related outcomes were accurate.
次要结局
- The Readiness and Enablement Index for Health Technology (READHY)(From enrollment to the end of treatment at 12 month)
研究者
Klaus Phanareth
Principal Investigator, MD, Ph.D.
ECM Klinikken APS