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IS-ACTIVE activity coach.


- candidate number10963
- NTR NumberNTR3245
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jan-2012
- Secondary IDs38996 ABR
- Public TitleIS-ACTIVE activity coach.
- Scientific TitleIS-ACTIVE activity coach.
- ACRONYMIS-ACTIVE
- hypothesisChronic Obstructive Pulmonary Disease (COPD) is a chronic, progressive lung disease. The prevalence and associated costs of COPD are projected to increase the upcoming decades. Symptomatic patients with COPD develop dyspnea and are dyspnoeic even when they perform normal daily activities. This leads to inactivity and subsequently, to physical deconditioning. A vicious cycle develops that greatly affects patientsí quality of life. The treatment of COPD aims to reduce risk factors, prevent disease progression and manage exacerbations. Increasing physical participation in everyday activities is among the key goals in COPD treatment.
Home-training programs and self-management have proven to be effective new training methods. Providing feedback to the patient about this physical activity behaviour is important to stimulate self-management. By focused feedback, we can try to positively influence the activity pattern, with the goal to be more physically active in daily life. A prerequisite is that this should be applied in daily life, so also in the home environment.
The IS-ACTIVE system is an activity coach that promotes an active lifestyle, in daily life. The aim is that patients become aware of their amount of daily physical activity and their daily activity pattern, and can improve their physical activity behaviour. The IS-ACTIVE study was designed because of the limited knowledge about the impact of feedback on the activity level of COPD patients on the long term. Besides the aim is to use a new, more intelligent, type of feedback that promotes COPD patients in having an active lifestyle.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), Selfmanagement, Telemedicine , Physical activity
- Inclusion criteria1. A clinical diagnosis of COPD according to the GOLD criteria, GOLD II-IV;
2. No exacerbation in the month prior to enrolment;
3. (Ex)smoker;
4. Age > 40 years;
5. Able to understand and read Dutch;
6. Internet access at home.
- Exclusion criteria1. Serious other disease with a low survival rate;
2. Other diseases influencing bronchial symptoms and/or lung function (e.g. cardiac insuficiency, sarcoidosis);
3. Severe psychiatric illness;
4. Need for regular oxygen therapy (>16 h per day or pO2<7.2 kPa);
5. Maintenance therapy with antibiotics;
6. Known alpha1-antitrypsine deficiency;
7. Disorders or progressive disease seriously influencing daily activities (e.g. amputation, paralysis, progressive muscle disease);
8. Impaired hand function causing inability to use application.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-feb-2014
- Target number of participants25
- InterventionsThe IS-ACTIVE system is an application for promotion of an active lifestyle of COPD patients. The system consists of a smartphone and an activity sensor. The smartphone displays the amount of measured activity in a graph, together with the patientís reference activity (the amount of activity the patient should aim for) per day. The reference activity is based on the baseline measurement. In addition, the patient receives feedback messages on the smartphone for extra motivation. Besides, the patient can log in to a webportal, to see his measured activity levels. The patient will use this for 3 months, for at least 4 days a week.
The primary objective of this study is to explore the clinical changes on the health status of the patient.

The secondary aim of this study is to evaluate the IS-ACTIVE system with COPD patients. We will investigate the use and usability of the application, the application satisfaction, and feedback compliance.
- Primary outcomeOutcome measures to evaluate the clinical changes are: Amount of activity (accelerometer, BPAQ), activity pattern (accelerometer), exercise tolerance (6MWT), fatigue (MFI-20), health status and symptoms (CCQ), and quality of life (EQ-5D).
- Secondary outcomeThe IS-ACTIVE system will be evaluated among patients in terms of use and usability of the application (registered by system/questionnaire and SUS), feedback compliance (registred by system), and satisfaction with the system (UTAUT).
- TimepointsT0 (inclusion), T1 (1 month), T2 (3 months), and 3 month follow-up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. M. Tabak
- CONTACT for SCIENTIFIC QUERIESMSc. M. Tabak
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
European Union
- PublicationsN/A
- Brief summaryThe IS-ACTIVE system is an activity coach that promotes an active lifestyle, in daily life. The aim is that patients become aware of their amount of daily physical activity and their daily activity pattern, and can improve their physical activity behaviour. The IS-ACTIVE study was designed because of the limited knowledge about the impact of feedback on the activity level of COPD patients on the long term. Besides the aim is to use a new, more intelligent, type of feedback that promotes COPD patients in having an active lifestyle. The primary objective of this study is to explore the clinical changes on the health status of the patient. The secondary aim of this study is to evaluate the IS-ACTIVE system with COPD patients. We will investigate the use and usability of the application, the application satisfaction, and feedback compliance.
- Main changes (audit trail)
- RECORD17-jan-2012 - 25-feb-2012


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