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

NCT01867970 | Completed

• 2 other identifiers: NL42580.068.1240-00812-98-09025
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Type 2 Diabetes

Keywords

remote sensing technology; physical activity; self-management support; primary care nursing

Outcome Measures

Primary Outcomes (2)

• 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.

  Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)

• 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.

  Change between T1 and T2: 3 months follow up

Secondary Outcomes (8)

• Quality of life

  Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)

• (General and Exercise) Self-efficacy

  Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)

• Health status

  Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)

• Quality of life

  Change between T1 and T2: 3 months follow up

• (General and Exercise) Self-efficacy

  Change between T1 and T2: 3 months follow up

Other Outcomes (2)

• Health status

  Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)

• Health status

  Change between T1 and T2: 3 months follow up

Study Arms (3)

Tool + Self-management Support Program

EXPERIMENTAL

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.

Device: Tool; Behavioral: Self-management Support Program

Self- management Support Program

EXPERIMENTAL

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.

Behavioral: Self-management Support Program

Care as usual

NO INTERVENTION

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.

Interventions

Tool DEVICE

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.

Also known as: MOX

Tool + Self-management Support Program

Self-management Support Program BEHAVIORAL

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.

Self- management Support Program; Tool + Self-management Support Program

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Luc de Witte

Maastricht, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 26209025 DERIVED

• 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.

  PMID: 24885096 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus, Type 2; Motor Activity

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

NL (1)