Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-based COPD Management Program Relative to Usual Care.
Brief Summary: There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung function, skeletal muscle weakness and weight loss are important determinants of impaired exercise performance, decreased quality of life and increased mortality. Based on earlier succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre developed an integrated, inter-disciplinary approach to the management of COPD including physical exercise, nutritional therapy, education, smoking cessation and psychological consultation. This COPD management program consists of a set of protocols that cover patient recruitment, diagnostic testing, treatment, follow-up and communication between professionals.

The exercise program and the nutitional therapy are carried out by local physiotherapists and dieticians working outside but in conjunction with the hospital. A program in such a setting could be substantially less expensive and certainly more easily accessible for many more patients than an inpatient or hospital-based outpatient rehabilitation program, as it is offered close to a patient's home. This study investigates the (cost-)effectiveness of the COPD management program compared to usual care in a randomized controlled trial.

Patients with moderate to severe COPD and a reduced exercise capacity during an incremental exercise test of less than 70% of predicted, are randomised to a treatment or a control group. The treatment group will participate in the COPD management program during the first 4 months after which they will be followed up for the remaining months. Both groups (n=100) are followed for 2 years and outcomes will be assessed at the beginning of the program, after 4, 12 and 24 months by disease-specific and generic measures of health status, body composition, skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility analysis with a two-year time horizon will be performed. The analysis is conducted from a societal perspectice, including the program costs and all COPD-related direct costs within and outside the healthcare sector ans costs of lost productivity.


Options:
A: Arm Label: Spirometry and a brief advice to quit smoking; Type: EXPERIMENTAL; Interventions: Behavioral: Spirometry and a brief advice to quit smoking | Arm Label: Brief advice to quit smoking; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Brief advice to quit smoking | Intervention Type: BEHAVIORAL; Name: Spirometry and a brief advice to quit smoking; Assigned to Arm(s): Spirometry and a brief advice to quit smoking | Intervention Type: BEHAVIORAL; Name: Brief advice to quit smoking; Assigned to Arm(s): Brief advice to quit smoking
B: Arm Label: Intercom; Type: EXPERIMENTAL; Interventions: Other: INTERdisciplinary COMmunity-based COPD management (INTERCOM) | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: INTERdisciplinary COMmunity-based COPD management (INTERCOM); Assigned to Arm(s): Intercom
C: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Bundle; Type: EXPERIMENTAL; Interventions: Behavioral: Bundle tool | Intervention Type: BEHAVIORAL; Name: Bundle tool; Assigned to Arm(s): Bundle
D: Arm Label: 1 Nix Individual; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Nix Individual | Arm Label: 2 Fimpa dig fri; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Fimpa dig fri | Intervention Type: BEHAVIORAL; Name: Nix Individual; Assigned to Arm(s): 1 Nix Individual | Intervention Type: BEHAVIORAL; Name: Fimpa dig fri; Assigned to Arm(s): 2 Fimpa dig fri

Answer: B