Interactive Tool to Support Self-management Through Lifestyle Feedback, Aimed at Physical Activity of COPD/DM Patients
Condition: Chronic Obstructive Pulmonary Disease; Type 2 Diabetes
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Rationale: Physical activity is an important factor for a healthy lifestyle. Although
      physical activity can delay complications and decrease the burden of the disease in
      chronically ill persons, their level of activity is often far from optimal. Many
      interventions have been developed to stimulate physical activity, with disappointing results.
      New in this field is the use of technology. Human persuasion (for example guidance by a
      practice nurse) can be enhanced by technological persuasion. Therefore a monitor and feedback
      tool, consisting of an accelerometer linked to a smart phone and webserver, has been
      developed and tested.

      Objective: The main objective of this study is to measure the effects of the monitoring and
      feedback tool embedded in a Self-management Support Program on physical activity. The
      secondary objective is to measure the effect on self-efficacy, quality of life and health
      status. In addition a process evaluation will be conducted.

      Study design: A three-armed cluster randomised controlled trial will be conducted with 240
      patients from 24 general practices. Randomisation level is the practice. The following
      conditions will be compared: 1) Tool and Self-management Support Program; 2) Self-management
      Support Program; 3) Care as usual. Outcome measures will be measured at t0 (before the start
      of the intervention), t1 (after 6 months, at the end of the intervention) and t2 (after 9
      months).

      Study population: 120 People with COPD and 120 people with Diabetes type 2 (aged 40-70)
      treated in primary care will be included from 24 GP practices.

      Intervention: Spread over a period of six months patients in condition 1 and 2 have to visit
      the practice nurse for 3-4 times for physical activity counselling. Specific activity goals
      will be set that are tailored to the individual patient's preferences and needs. On top of
      this, patients in condition 1 will be instructed to use the monitoring and feedback tool in
      daily life. Patients in condition 3 will not be exposed to any intervention.

      Main study parameters/endpoints: Primary outcome: physical activity measured with a physical
      activity monitor (PAM). Secondary outcomes: quality of life, general self-efficacy, exercise
      self-efficacy and health status.
    

Detailed description: 
      A detailed study protocol is published Verwey, R., S. van der Weegen, et al. (2014). "A
      monitoring and feedback tool embedded in a counselling protocol to increase physical activity
      of patients with COPD or type 2 diabetes in primary care: study protocol of a three-arm
      cluster randomised controlled trial." BMC Family Practice 15(1): 93.

      http://www.biomedcentral.com/1471-2296/15/93
    

Intervention name(s): Tool; Self-management Support Program
Intervention type(s): Device; Behavioral
Intervention description(s): The It's LiFe! tool consists of three different elements:
the 3D accelerometer (Figure 7-8);
the application (app) on a Samsung Smartphone (Figure 6);
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.; 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.
Other intervention name(s): MOX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: remote sensing technology; physical activity; self-management support; primary care nursing