Self-Management And Telemedicine in patients with COPD and chronic Heart failure.
- Conditions
- Chronic obstructive pulmonary disease (COPD)Chronic Obstructive Airway Disease/ chronic heart failure1001928010006436
- Registration Number
- NL-OMON46744
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
- A clinical diagnosis of COPD according to the GOLD 2017 criteria (Forced Expiratory Volume in one second (FEV1) < 80% of the predicted value and FEV1/Vital Capacity (FVC) < 0.70
- Chronic Heart Failure (CHF) defined according to the current (2016) ESC guidelines
- * 2 COPD and/or CHF exacerbations* and/or *1 hospitalisation for COPD and/or CHF in the two years preceding study entry
- * 40 years of age
- At least 1 week after prednisolone/antibiotics/furosemide course. At least 1 week after hospitalisation. At least 4 weeks post-rehabilitation.
- Able to understand and read the Dutch language
- Able to use a tablet
- Written informed consent from the subject prior to participation.
- Terminal cancer or the end stage of another serious disease;
- Other serious lung disease (e.g. 1-antitrypsin deficiency; interstitial lung diseases);
- Expected cardiovascular intervention within three months.
- Being currently enrolled in randomized controlled trials or trial with study medication
- Waiting for a heart or lung transplantation
- Receiving of renal dialysis
- Diabetes Mellitus type I
- HADS (Hospital Anxiety and Depression Scale)-score of * 11 for depression and/or anxiety
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study endpoints are the satisfaction of patients with and adherence to<br /><br>(the different components of) the telemedicine self-management interventions.<br /><br>Also, motivation of patients and health care providers to use the<br /><br>self-management platform is one of the main study endpoints. Semi-structured<br /><br>interviews with patients and case managers will be performed for a qualitative<br /><br>evaluation of these endpoints. Other assessments of satisfaction will be the<br /><br>Client Satisfaction Questionnaire and the rating of satisfaction by using a<br /><br>four-point scale. Adherence to the different components of the telemedicine<br /><br>self-management intervention will be assessed by the frequency and time that<br /><br>patients use the different modules of the platform, the number of diary<br /><br>completion and the frequency of acting according to action plans.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are: 1) the added value of the laboratory test NTproBNP to<br /><br>differentiate between dyspnoea caused by exacerbations of COPD or of heart<br /><br>failure during this self-management intervention (frequency of measuring<br /><br>NTproBNP and frequency of treatment change according the NTproBNP, 2) inhaler<br /><br>technique and patients* adherence to inhalation medication by using sensorised<br /><br>inhalers and 3) improvement of inhaler technique and adherence after feedback<br /><br>(by measuring and comparing these variables at the first, sixth and last week<br /><br>of the study). We will assess the effects of the intervention on quality of<br /><br>life by using questionnaires. </p><br>