Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - A clinical diagnosis of COPD according to the GOLD 2017 criteria (Forced Expiratory Volume in one second (FEV1)
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoints are the satisfaction of patients with and adherence to (the different components of) the telemedicine self-management interventions. Also, motivation of patients and health care providers to use the self-management platform is one of the main study endpoints. Semi-structured interviews with patients and case managers will be performed for a qualitative evaluation of these endpoints. Other assessments of satisfaction will be the Client Satisfaction Questionnaire and the rating of satisfaction by using a four-point scale. Adherence to the different components of the telemedicine self-management intervention will be assessed by the frequency and time that patients use the different modules of the platform, the number of diary completion and the frequency of acting according to action plans. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: 1) the added value of the laboratory test NTproBNP to differentiate between dyspnoea caused by exacerbations of COPD or of heart failure during this self-management intervention (frequency of measuring NTproBNP and frequency of treatment change according the NTproBNP, 2) inhaler technique and patients* adherence to inhalation medication by using sensorised inhalers and 3) improvement of inhaler technique and adherence after feedback (by measuring and comparing these variables at the first, sixth and last week of the study). We will assess the effects of the intervention on quality of life by using questionnaires. | — |
Countries
The Netherlands