Innovative monitoring and personalised feedback as a self management tool in disease management programmes for people with chronic diseases; a randomised controlled trial

This proposal concerns the development and evaluation of an innovative approach to support patients with diabetes or COPD in their self management regarding physical activity, making use of a new technological tool, embedded in a health care programme based on shared decision making and current insights into chronic disease management. In most guidelines and care standards regarding chronic diseases, stimulating physical activity is a central element. Unfortunately, implementation of physical activity guidelines shows disappointing results and long term adherence to physical activity after supervised training programs is generally poor. Technology may play an important role in improving adherence to lifestyle interventions. We aim to develop and evaluate an innovative monitoring and feedback tool, tailored to patient’s and professionals’ needs, that supports patients in their self management role. We also aim to develop and evaluate a health care model in which the use of the monitoring and feedback tool can be integrated. The project consists of three parts. The first part regards the development and testing of the monitoring and feedback tool, as well as the integration of the use of this monitoring and feedback tool into the health care process (development of a health care model). The monitoring system consists of an activity monitor and a data acquisition platform that is able to collect and process data from different sensors and to send these to a mobile phone and/or a website. The feedback tool will generate easy to understand and specific feedback and must also fit into the work processes of professional care providers involved. A summary of the monitoring data will be made available as feedback to the care provider. In this way a double feedback loop is created: directly to the patient and a summary to the care provider, who can then discuss the results with the patient. The health care model in which the monitoring and feedback tool is embedded will be based on the principles of patient involvement, shared decision making and the Chronic Care Model. The second part of the project is a field trial to evaluate the feasability, usability and technical performance of the monitoring and feedback tool and the protocol/procedure regarding embedding it into the health care process. A group of 20 patients and related caregivers (10 with diabetes and 10 with COPD) will participate in this field trial. The third part of the project is a randomised controlled trial to evaluate the effectiveness of both the technological monitoring and feedback system and the health care model ‘surrounding’ it. One group will receive the monitoring and feedback tool embedded in the health care model developed, one group will receive the same health care intervention but not the feedback tool, and one group will receive care as usual. General practices will be the unit of randomization; 24 practices will be randomized into three equal groups. Each general practitioner should include 10 of their patients (COPD or diabetes) into the study. In eight practices the nurse practitioners will be trained to apply the technological monitoring and feedback tool as well as the health care model, the nurse practitioners in another group of eight practices will only be trained to apply the health care model and the nurse practitioners in the remaining eight practices will be asked to continue care as usual. The study population for the RCT consists of 120 patients with type 2 diabetes and 120 patients with COPD. Each study group will contain 80 patients, 40 with diabetes and 40 with COPD. The intervention consists of two parts: 1) the monitoring and feedback tool; 2) the health care model in which this tool will be embedded. Both will be elaborated in part 1 of the project and evaluated for their feasability, usability and technical performance in part 2. The primary outcomes in this effectiveness study are physical activity and goal attainment. Secondary outcomes are quality of life and self-efficacy. The basis of the monitoring and feedback tool is the so-called Sensorphone platform, which was developed by one of the partners in this study (Maastricht Instruments).The platform has been tested in several field trials with very promising results. The Sensorphone concept is a combination of a modular ambulant data acquisition unit (PASAQ) with wearable sensors and communication infrastructure (mobile phone and website), able to monitor activity/mobility and vital signs (e.g. ECG) simultaneously and in real time. The project will result in two PhD theses and a number of scientific publications. The two SME’s involved in the project intend to bring the final tool, together with the health care model and related services to the market. They see large potential, which is demonstrated by their in kind contribution to the study.