Interactive Tool to Support Self-management Through Lifestyle Feedback, Aimed at Physical Activity of COPD/DM Patients
- Conditions
- Type 2 DiabetesChronic Obstructive Pulmonary Disease
- Interventions
- Behavioral: Self-management Support ProgramDevice: Tool
- Registration Number
- NCT01867970
- Lead Sponsor
- Maastricht University Medical Center
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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
-Patients older than 70 years are not included because of a bigger risk for co-morbidity and a higher chance of mobility problems (balance)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self- management Support Program 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. Tool + Self-management Support Program Tool 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. Tool + Self-management Support Program 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.
- Primary Outcome Measures
Name Time Method Physical activity Change between T1 and T2: 3 months follow up 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.
- Secondary Outcome Measures
Name Time Method Quality of life Change between T1 and T2: 3 months follow up 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.
Health status Change between T1 and T2: 3 months follow up 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.(General and Exercise) Self-efficacy Change between T1 and T2: 3 months follow up 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.Physical activity in daily life Change between T1 and T2: 3 months follow up 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.
Trial Locations
- Locations (1)
Luc de Witte
🇳🇱Maastricht, Netherlands