Interactive Tool to Support Self-management Through Lifestyle Feedback, Aimed at Physical Activity of COPD/DM Patients

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Type 2 Diabetes

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2014-09-30

Completion

2014-10-31

Countries

• Netherlands

Study Locations