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Self-Management And Telemedicine in patients with COPD and chronic Heart failure.


- candidate number27744
- NTR NumberNTR6667
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-aug-2017
- Secondary IDsP17-17 
- Public TitleSelf-Management And Telemedicine in patients with COPD and chronic Heart failure.
- Scientific TitleSelf-Management And Telemedicine in patients with COPD and chronic Heart failure.
- ACRONYMMATCH
- hypothesisCOPD is a common chronic pulmonary disease in (vulnerable) elderly people, that in 25% coexists with chronic heart failure. Both COPD and chronic heart failure have a high burden of disease with intermittent disease deteriorations (exacerbations) that may lead to hospital admissions.
Self-management interventions for patients with COPD (and comorbidities) are proven effective on different health outcomes. The COPE-III study for example showed significant beneficial effects of a self-management intervention with patient-tailored action plans for patients with COPD and comorbidities (including heart failure amongst others) on COPD exacerbation duration and respiratory related hospitalisations. The aim of this pilot study is to analyse the satisfaction with and adherence to a telemedicine self-management intervention for patients with COPD and heart failure. This self-management intervention is based on the COPE-III study. Implementation of a self-management intervention in a home-based telemedicine platform with an avatar for better communication and personal feedback might improve the applicability of self-management interventions (e.g. for patients with reduced mobility) and could make it more patient-tailored. It might lead to earlier recognition of worsening of symptoms and quicker initiation of treatment because real time monitoring and prompt feedback is possible
- Healt Condition(s) or Problem(s) studiedCOPD, Heart failure, Selfmanagement, Telemedicine
- Inclusion criteria- A clinical diagnosis of COPD according to the GOLD 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 year 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 smart phone, tablet or PC
- Written informed consent from the subject prior to participation.
- 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 renal dialysis
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 15-sep-2017
- planned closingdate15-apr-2018
- Target number of participants20
- InterventionsTelemedicine self-management intervention for patients with COPD and heartfailure
- Primary outcome- Satisfaction with received care
- Adherence to the telemedicine self-management intervention
- the added value of the different components of the telemedicine self-management intervention
- motivation of patients to use the telemedicine self-management intervention.
- Secondary outcome- Inhaler technique measured by using sensorised inhalers
- Adherence to inhalers
- Improvement of inhaler technique after feedback from an avatar
- The added value of measuring the laboratory test NTproBNP to differentiate between breathlessness caused by COPD exacerbations or by deterioration of chronic heart failure
- quality of life
- TimepointsMonth 1: patients participate in self-management courses (3 courses) and start using the telemedicine platform after the second course
Month 2-4: follow-up: the use of the telemedicine self-management platform.
- Trial web site-
- status[default]
- CONTACT FOR PUBLIC QUERIES Joanne Sloots
- CONTACT for SCIENTIFIC QUERIES Joanne Sloots
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryCOPD is a common chronic pulmonary disease in (vulnerable) elderly people, that in 25% coexists with chronic heart failure. Both COPD and chronic heart failure have a high burden of disease with intermittent disease deteriorations (exacerbations) that may lead to hospital admissions.
Self-management interventions for patients with COPD (and comorbidities) are proven effective on different health outcomes. The COPE-III study for example showed significant beneficial effects of a self-management intervention with patient-tailored action plans for patients with COPD and comorbidities (including heart failure amongst others) on COPD exacerbation duration and respiratory related hospitalisations. Incorporating this self-management intervention in a home-based digital platform with an avatar for personalized feedback may improve the applicability of self-management interventions and could make it more patient-tailored. It may lead to earlier recognition of worsening of symptoms and quicker initiation of treatment because real time monitoring and prompt feedback is possible. During this pilot study, we intend to investigate the feasibility of a home-based patient-tailored telemedicine self-management intervention for patients with COPD and chronic heart failure over a 4-month period. This telemedicine self-management intervention will include an automated decision support system of action plans for exacerbations of COPD, heart failure and other comorbidities. These action plans were proven effective in the COPE-II study. Further it will include testing of the laboratory test NTproBNP in case of doubts whether increased dyspnoea is caused by COPD or heart failue. Sensorised inhalers will be used to monitor patients' inhaler technique and adherence. An avatar will give personal feedback on patients' diary completion, action plan use and use/technique of inhalers and will motivate patients to use the different modules of the telemedicine platform.
- Main changes (audit trail)
- RECORD14-aug-2017 - 10-sep-2017


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