Clinical trial NCT01867970: Interactive Tool to Support Self-management Through Lifestyle Feedback, Aimed at Physical Activity of COPD/DM Patients
Official title: RCT It's LiFe! to Evaluate the Effectiveness of the Monitoring and Feedback Tool and the Corresponding Counseling Protocol (Self-management Support Program) to be Executed by Practice Nurses in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Type 2 Diabetes
Keywords: remote sensing technology
physical activity
self-management support
primary care nursing
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2013-06-04
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* People diagnosed with COPD or diabetes type 2 who are predominantly treated in primary care and who benefit from more physical activity, will be included. -This means patients who do not comply with the Dutch Norm for Healthy Exercise (30 minutes activity per day of a moderate intensity during five days a week)
* Their age should be between 40-70 years to ensure homogeneity in the groups
* Additional inclusion criteria for the diabetes group are a recent (no longer than a year ago) HbA1c concentration of more than 7% / more than 53 mmol/mol and a body mass index of more than 25kg/m2

For the COPD group the following additional inclusion criteria apply:

-A clinical diagnosis of COPD according to the GOLD-criteria stage 1, 2 and 3 (post bronchodilator FEV1/IVC \<= 70% and FEV1 between 30 and 80% of the predicted value); at least six weeks respiratory stable and on a stable drug regimen

Exclusion Criteria:

-Patients older than 70 years are not included because of a bigger risk for co-morbidity and a higher chance of mobility problems (balance)

Primary outcomes:
measure: Physical activity
timeFrame: Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)
measure: Physical activity
timeFrame: Change between T1 and T2: 3 months follow up
Secondary outcomes:
measure: Quality of life
timeFrame: Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)
measure: (General and Exercise) Self-efficacy
timeFrame: Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)
measure: Health status
timeFrame: Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)
measure: Quality of life
timeFrame: Change between T1 and T2: 3 months follow up
measure: (General and Exercise) Self-efficacy
timeFrame: Change between T1 and T2: 3 months follow up
measure: Health status
timeFrame: Change between T1 and T2: 3 months follow up
measure: Physical activity in daily life
timeFrame: Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)
measure: Physical activity in daily life
timeFrame: Change between T1 and T2: 3 months follow up
Other outcomes:
measure: Health status
timeFrame: Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)
measure: Health status
timeFrame: Change between T1 and T2: 3 months follow up
Locations:
city: Maastricht
country: Netherlands
facility: Luc de Witte
Study officials:
References:
citation: van der Weegen S, Verwey R, Spreeuwenberg M, Tange H, van der Weijden T, de Witte L. It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Jul 24;17(7):e184. doi: 10.2196/jmir.4579.
citation: Verwey R, van der Weegen S, Spreeuwenberg M, Tange H, van der Weijden T, de Witte L. 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 Fam Pract. 2014 May 12;15:93. doi: 10.1186/1471-2296-15-93.