Please select the arm or intervention descriptions that belong 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: Arm Label: Control group (Group A); Type: ACTIVE_COMPARATOR; Interventions: Other: Usual care | Arm Label: Intervention group (Group B); Type: OTHER; Interventions: Other: Home-based telehealth program, Other: Home-based rehabilitation, Other: Usual care | Intervention Type: OTHER; Name: Home-based telehealth program; Assigned to Arm(s): Intervention group (Group B) | Intervention Type: OTHER; Name: Home-based rehabilitation; Assigned to Arm(s): Intervention group (Group B) | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): Control group (Group A), Intervention group (Group B)
B: Arm Label: Telerehabilitation; Type: EXPERIMENTAL; Interventions: Other: telerehabilitation | Arm Label: Standard chronic care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: telerehabilitation; Assigned to Arm(s): Telerehabilitation
C: Arm Label: Hospital-based; Type: EXPERIMENTAL; Interventions: Behavioral: Pulmonary rehabilitation (teaching and exercise) | Arm Label: Home-Based; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Pulmonary rehabilitation (teaching and exercise) | Intervention Type: BEHAVIORAL; Name: Pulmonary rehabilitation (teaching and exercise); Assigned to Arm(s): Home-Based, Hospital-based
D: Arm Label: Tool + Self-management Support Program; Type: EXPERIMENTAL; Interventions: Device: Tool, Behavioral: Self-management Support Program | Arm Label: Self- management Support Program; Type: EXPERIMENTAL; Interventions: Behavioral: Self-management Support Program | Arm Label: Care as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Tool; Assigned to Arm(s): Tool + Self-management Support Program | Intervention Type: BEHAVIORAL; Name: Self-management Support Program; Assigned to Arm(s): Self- management Support Program, Tool + Self-management Support Program

Answer: D