Interactive Tool to Support Self-management Through Lifestyle Feedback, Aimed at Physical Activity of COPD/DM Patients (RCTIt'sLiFe!)

実験的：Tool + Self-management Support Program

The system consists of three elements: a 3D accelerometer worn on the hip together with; an application (app) on a smartphone; a server and a website. The patient receives three types of feedback on the mobile phone concerning the amount of activity, the amount of activity in relation to an activity goal, and the response of a nurse based on the measured activity. Practice nurses will use a consultation approach to coach patients in their self-management regarding physical activity based on a "five A's cycle" counselling technique (assess-advise-agree-assist-arrange). Motivational interviewing, risk assessment, and goal setting are specific aspects of this approach.The patient comes to the practice four times: in the first week, after 2 weeks, after 8-12 weeks and after 16-24 weeks.

デバイス：Tool

The It's LiFe! tool consists of three different elements:

1. the 3D accelerometer (Figure 7-8);
2. the application (app) on a Samsung Smartphone (Figure 6);
3. a web application and server called It's LiFe! online (powered by Sananet). The transmission of data from the accelerometer towards the app is via a Bluetooth connection. Every 15 minutes, or when the users press the refresh button, the Smartphone will connect to the accelerometer. The accelerometer should be within a 5 meter distance from the Smartphone. The transmission of data from the Smartphone towards the It's LiFe! server is via an internet connection. Therefore the Smartphone needs a SIM card with a data subscription.

他の名前：

• MOX

行動：Self-management Support Program

Consultations 1)The PN will increase awareness of the PA pattern, she will inform the patient about the health risks related to a sedentary lifestyle. Assessment of the PA level is done by completing the SQUASH questionnaire. The patient gets a leaflet with information about being active. 2)A day goal will be set in minutes a day, based on the results of the measurements of the first two weeks. The pre-measurement in condition 1 is an objective measurement by the tool and they are visible for the PN on the monitor portal of the It's LiFe! Server. The PN will encourage the patient to focus on goals that fit to the patient's preferences and to set up a SMART plan to reach personal goal. 3)The PN will discuss the results and barriers and facilitators related to physical activities. 4)The PN will discuss the results, behavior change and habits, with the patient.

実験的：Self- management Support Program

Practice nurses will use a consultation approach to coach patients in their self-management regarding physical activity based on a "five A's cycle" counselling technique (assess-advise-agree-assist-arrange). Motivational interviewing, risk assessment, and goal setting are specific aspects of this approach.The patient comes to the practice four times: in the first week, after 2 weeks, after 8-12 weeks and after 16-24 weeks.

行動：Self-management Support Program

Consultations 1)The PN will increase awareness of the PA pattern, she will inform the patient about the health risks related to a sedentary lifestyle. Assessment of the PA level is done by completing the SQUASH questionnaire. The patient gets a leaflet with information about being active. 2)A day goal will be set in minutes a day, based on the results of the measurements of the first two weeks. The pre-measurement in condition 1 is an objective measurement by the tool and they are visible for the PN on the monitor portal of the It's LiFe! Server. The PN will encourage the patient to focus on goals that fit to the patient's preferences and to set up a SMART plan to reach personal goal. 3)The PN will discuss the results and barriers and facilitators related to physical activities. 4)The PN will discuss the results, behavior change and habits, with the patient.

介入なし：Care as usual

Patients attend the practice regularly: at least once a year for a consultation with the GP. In addition, COPD patients have consultations (15-30 minutes) with the practice nurse once or twice a year. Most patients with diabetes type 2 see the GP ones per year and the practice nurse three times per year for a health check.Normally, physical activity is not high on the agenda during consultations with the practice nurse. Barriers for paying attention are the competition with other topics that should also be covered during consultations, co-morbidity and limitations of patients, and the assumption of most practice nurses that nowadays the patient decides on the topics of the consultation. All interviewees agreed that many patients do not perceive physical activity as an important issue.

Physical activity

Physical activity will be measured with the Personal Activity Monitor (PAM). The PAM is a small (58 x 42 x 13 mm, weight 28 gram) tri-axial accelerometer that can be easily attached to a belt and is worn on the hip. The PAM registers all movements that are made on a day and measures the intensity of hip movements. Via a docking station, which must be connected to the internet, the PAM scores can be uploaded and converted into minutes a day in a sedentary category (< 1.8 METS) a living category (1.8-3 METS) a moderate category (3-7 METS) and a vigorous category (>7 METS). The number of minutes of physical activity in the moderate and vigorous category is used as an outcome measurement. The possibility of noticing (e.g. providing feedback) users about their activity scores and their calories used will be deactivated; the displays will be turned off. The level of physical activity in minutes a day at t0 will be compared to the minutes of activity at t1 and t2.

Physical activity

Physical activity will be measured with the Personal Activity Monitor (PAM). The PAM is a small (58 x 42 x 13 mm, weight 28 gram) tri-axial accelerometer that can be easily attached to a belt and is worn on the hip. The PAM registers all movements that are made on a day and measures the intensity of hip movements. Via a docking station, which must be connected to the internet, the PAM scores can be uploaded and converted into minutes a day in a sedentary category (< 1.8 METS) a living category (1.8-3 METS) a moderate category (3-7 METS) and a vigorous category (>7 METS). The number of minutes of physical activity in the moderate and vigorous category is used as an outcome measurement. The possibility of noticing (e.g. providing feedback) users about their activity scores and their calories used will be deactivated; the displays will be turned off. The level of physical activity in minutes a day at t0 will be compared to the minutes of activity at t1 and t2.

Quality of life

To measure the quality of life of participants the Dutch version of the SF-36 will be used (see appendix F1.3). The SF-36 is a generic health status instrument designed for the use across a wide range of chronic disease populations. "The SF-36 has shown an excellent reliability and validity in diverse patient populations in the US and the Netherlands. The SF-36 is composed of 36 items, organized into 8 multi-item scales covering a similar number of dimensions, including physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health.". A higher score on the SF-36 indicates a better quality of life.

(General and Exercise) Self-efficacy

Self-efficacy is described as people's belief in their capability to organize and execute the course of action required to deal with prospective situations. Self-efficacy is an important construct since it influences the processes of planning, taking initiative, maintaining behaviour change, and managing relapses.

To measure self-efficacy of participants two questionnaires will be used: the Dutch adaptation of the General Self-Efficacy Scale (GSE) from Jerusalem and Schwarzer (1995) and the Dutch adaptation of the Exercise Self-efficacy Scale (ESS) developed by Bandura (1997). The GSE contains 10 questions in a 4 points response format and the ESS contains 18 questions regarding different situations related to exercise with a scale response format from 0-100.

Health status

Personal reported health status will be measured by a disease specific questionnaire.

For diabetes the Diabetes Symptom Checklist-revised (DSC-R) will be used. On the 34 items of the DSC-R, participants first indicate whether they have experienced each symptom in the past 4 weeks. If "yes" is selected, the participant continues to rate how troublesome that symptom is on a 5-point scale ranging from 1 (not at all) to 5 (extremely). The instrument yields a total score and the following subscales: Fatigue, Cognitive, Pain, Sensory, Cardiology, Ophthalmology, Hypoglycemia, and Hyperglycemia. The total score and all dimension scores range from 0 to 5. Higher scores indicate greater symptom burden.

For COPD the Chronic Respiratory Questionnaire (CRQ) will be used. The CRQ consists of four domains: fatigue, dyspnoea, mastery (the patient's feeling of control over their disease), and emotional function.

Quality of life

To measure the quality of life of participants the Dutch version of the SF-36 will be used (see appendix F1.3). The SF-36 is a generic health status instrument designed for the use across a wide range of chronic disease populations. "The SF-36 has shown an excellent reliability and validity in diverse patient populations in the US and the Netherlands. The SF-36 is composed of 36 items, organized into 8 multi-item scales covering a similar number of dimensions, including physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health.". A higher score on the SF-36 indicates a better quality of life.

(General and Exercise) Self-efficacy

Self-efficacy is described as people's belief in their capability to organize and execute the course of action required to deal with prospective situations. Self-efficacy is an important construct since it influences the processes of planning, taking initiative, maintaining behaviour change, and managing relapses.

To measure self-efficacy of participants two questionnaires will be used: the Dutch adaptation of the General Self-Efficacy Scale (GSE) from Jerusalem and Schwarzer (1995) and the Dutch adaptation of the Exercise Self-efficacy Scale (ESS) developed by Bandura (1997). The GSE contains 10 questions in a 4 points response format and the ESS contains 18 questions regarding different situations related to exercise with a scale response format from 0-100.

Health status

Personal reported health status will be measured by a disease specific questionnaire.

For diabetes the Diabetes Symptom Checklist-revised (DSC-R) will be used. On the 34 items of the DSC-R, participants first indicate whether they have experienced each symptom in the past 4 weeks. If "yes" is selected, the participant continues to rate how troublesome that symptom is on a 5-point scale ranging from 1 (not at all) to 5 (extremely). The instrument yields a total score and the following subscales: Fatigue, Cognitive, Pain, Sensory, Cardiology, Ophthalmology, Hypoglycemia, and Hyperglycemia. The total score and all dimension scores range from 0 to 5. Higher scores indicate greater symptom burden.

For COPD the Chronic Respiratory Questionnaire (CRQ) will be used. The CRQ consists of four domains: fatigue, dyspnoea, mastery (the patient's feeling of control over their disease), and emotional function.

Physical activity in daily life

The PAM scores and the number of minutes of PA in the living, moderate and vigorous category >1.8 METS. These measures indicate all types of activity during the day.

Physical activity in daily life

The PAM scores and the number of minutes of PA in the living, moderate and vigorous category >1.8 METS. These measures indicate all types of activity during the day.

Health status

If available in the medical record of the general practitioner, disease specific health outcomes will be extracted, such as CCQ, MRC values for COPD patients and Hba1C blood values for diabetes patients, blood pressure and BMI.

Health status

If available in the medical record of the general practitioner, disease specific health outcomes will be extracted, such as CCQ, MRC values for COPD patients and Hba1C blood values for diabetes patients, blood pressure and BMI.