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COPD dot COM.


- candidate number8258
- NTR NumberNTR2440
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jul-2010
- Secondary IDs33403 ABR
- Public TitleCOPD dot COM.
- Scientific TitleEffectiveness of feedback, by the use of remote monitoring, on daily activity patterns in patients with COPD.
- ACRONYM
- hypothesisFeedback to the COPD patient about his condition and physical activity plays an important role in promoting self management. Within the current care for patients with COPD, there is a lack of insight into daily activities and lack of understanding of the impact of physical training on the disease status. In addition, still working with paper patient files with the disadvantage that they are not constantly updated and current information missing. This idea is the 'dot COM COPD "study designed to target a prototype system to develop and test, to manage symptoms in COPD patients where the system can be tailored to the individual needs of patients and so fits the current healthcare system that can be implemented in daily care. Considerations in this study with regard to preventing deterioration of disease status and encourage an active lifestyle. The patient is supported and led by Information and Communication Technology (ICT) in achieving its goals and self-management of complaints. In addition, the system can give insight professionals involved in the current disease status so they can give timely advice and mutual information exchange.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD)
- Inclusion criteria1. A clinical diagnosis of stable COPD defined by GOLD criteria;
2. GOLD classification II-III;
3. Able to read, write and understand Dutch language;
4. Internet access at home.
- Exclusion criteria1. Exacerbation in four weeks prior to measurement;
2. Impaired hand function; inability to control application;
3. Comorbidity which restricts movement activities;
4. Pathological changes which may affect activities of daily living (eg, stroke, osteoarthritis, arthritis, rheumatoid arthritis);
5. Asthma;
6. Other present and active lung disease;
7. Use of oxygen;
8. Less than six weeks ago started to workout with the physiotherapist.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2010
- planned closingdate31-dec-2010
- Target number of participants32
- InterventionsTwo groups of 16 patients will be formed. The control group wears a pedometer during four weeks, 4 days of the week (Yamax DigiWalker 200).
The intervention group uses the same pedometer as the control group with the COPD dot COM prototype system consisting of MTX-W motion sensor (Xsens) and Personal Digital Assistant ([PDA] (HTC P3600/P3700) and a touchscreen (or their own computer) linking to a Web portal.
The patients must wear both pedometer and MTX-W sensor and PDA around their waist, from when they wake up until at least eight PM. In the intervention group, the PDA provides feedback in the form of counseling. In addition, the intervention group completes a daily diary of their symptoms on the portal. Based on the subjective reports feedback about starting a course of prednisolone and / or antibiotics is given. Both groups have to write down per part of the day how many steps the pedometer measured.
- Primary outcomeDoes activity increase in COPD patients, receiving feedback from the prototype COPD dot COM system, measured in number of steps per day, compared with a group of COPD patients without feedback?
- Secondary outcome1. Is the distribution of activities throughout the day more evenly distributed in patients using the COPD dot COM application with feedback compared with a group of patients who have received no feedback?
2. What is the correlation between the two different measurements (pedometer and MTX-W motion sensor)?
- TimepointsIn the intervention group, the first five days the motion sensor detects movement activities measured without feedback. Based on this average measurement a reference line is calculated (by delta method).
The measurement takes over 4 weeks, 4 days a week. In addition, both groups per half day (morning 8.00-13.00 hours 13.00-17.00 hours noon, evening 17.00-20.00 hours) record how many steps the pedo meter measured.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marloes Scholten
- CONTACT for SCIENTIFIC QUERIESProf. dr. J. Palen, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryFeedback to the COPD patient about his condition and physical activity plays an important role in promoting self management. Within the current care for patients with COPD, there is a lack of insight into daily activities and lack of understanding of the impact of physical training on the disease status. In addition, still working with paper patient files with the disadvantage that they are not constantly updated and current information missing. That's why the 'COM dot COPD "study is designed to target a prototype system to develop and test, to manage symptoms in COPD patients where the system can be tailored to the individual needs of patients and so fits the current healthcare system that can be implemented in daily care. Considerations in this study with regard to preventing deterioration of disease status and encourage an active lifestyle. The patient is supported and led by Information and Communication Technology (ICT) in achieving its goals and self-management of complaints. In addition, the system can give insight professionals involved in the current disease status so they can give timely advice and mutual information exchange.
- Main changes (audit trail)
- RECORD24-jul-2010 - 8-okt-2010


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