Please select the eligibility criteria that correspond to the clinical trial below.
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
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.


Options:
A: Inclusion Criteria:

* • Men and women age 40 years and older

  * Current or former smoker of at least 10 pack-years
  * Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or IV COPD as documented by pulmonary function
  * Are eligible for Pulmonary Rehabilitation

Exclusion Criteria:

* • Unable to perform mild exercises

  * Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
  * Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
B: Inclusion Criteria:

* Adult \>= 40 years old
* Diagnosis of COPD, emphysema or chronic bronchitis
* Able to walk a minimum of one block
* Sedentary, defined by less than 150 minutes of self-reported physical activity per week
* Have a doctor or primary care provider in the VA who can provide medical clearance
* Competent to give informed consent
* Must be a regular email user (check weekly)
* Have access to a computer with an internet connection, a USB port, and Windows XP or Vista

Exclusion Criteria:

* Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or procedures within the previous year will be excluded from potential participant pool
C: 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)
D: Inclusion Criteria:

To be eligible for inclusion in this study Patients fulfil all of the following criteria:

1. Written informed consent obtained before any assessment is performed.
2. Male and female patients ≥ 40 years of age
3. Diagnosis of COPD \[post-bronchodilator forced expiratory volume at one second (FEV1) \<80% predicted and FEV1/ forced vital capacity (FVC) \<75% without significant post-bronchodilator reversibility (\<10% FEV1 % predicted normal)\]
4. Optimal medical treatment according to GOLD without regular use of systemic corticosteroids
5. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
6. Absence of other significant diseases that could contribute to exercise limitation
7. At least 2 COPD exacerbations the year before the time entry

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions are applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

1. Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased.
2. Respiratory diseases other than COPD (e.g. asthma)
3. Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the tablet, as judged by the investigator
4. Patients not on optimal pharmacotherapy
5. No COPD exacerbations the year before the time entry

Answer: C