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:

* 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)
B: Inclusion Criteria:

* Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.
* Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.
* Patient on RR for four weeks in respiratory rehabilitation center.
* Aged between 40 and 78 years.

Exclusion Criteria:

* Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
* Patients with significant and unstable cardiovascular disease.
* Inability to understand and/or answer questionnaires.
* Refusal to use a smartphone or digital device.
* Unable to access an internet connection at home.
C: Inclusion Criteria:

* A diagnosis of COPD
* Suitable for participation in the NHS Lanarkshire PR programme
* Independently mobile
* Access to the internet in their own home

Exclusion Criteria:

* Unstable cardiac or other health problems which may prevent participation in study
* Under the age of 18
* Pregnant
* Unable to read/understand English
* Unwilling to be randomised into PR delivered via the hospital or internet
D: Inclusion Criteria:

* Diagnosis of COPD

Exclusion Criteria:

* Diagnosis of other significant lung disease (eg. interstitial lung disease) or dementia
* Lack of WiFi at home
* Inability to speak English
* Inability to use this technology due to physical or cognitive impairment

Answer: A