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: usual care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: care at initiative of the patient (usual GP care) | Arm Label: monitoring controls; Type: EXPERIMENTAL; Interventions: Behavioral: regular practice nurse review (monitoring controls) | Arm Label: self-management; Type: EXPERIMENTAL; Interventions: Behavioral: an integrated self-management education program | Intervention Type: BEHAVIORAL; Name: an integrated self-management education program; Assigned to Arm(s): self-management | Intervention Type: BEHAVIORAL; Name: regular practice nurse review (monitoring controls); Assigned to Arm(s): monitoring controls | Intervention Type: BEHAVIORAL; Name: care at initiative of the patient (usual GP care); Assigned to Arm(s): usual care
B: Arm Label: Case Management; Type: EXPERIMENTAL; Interventions: Behavioral: 40 minute standardized education session, Behavioral: Individualized action plan, Behavioral: Individualized care plan, Behavioral: Standardized reinforcement/motivational interviewing and action plan teach-back sessions, Behavioral: Tele-home monitoring, Behavioral: Coordinated and improved communication, Behavioral: Priority access, Behavioral: Dictated patient summary, Behavioral: in-hospital rehabilitation/self-management program, Behavioral: Smoking cessation | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Dictated patient summary, Behavioral: in-hospital rehabilitation/self-management program, Behavioral: Smoking cessation, Behavioral: Action plan Respirologist, Behavioral: Web based self management materials | Intervention Type: BEHAVIORAL; Name: 40 minute standardized education session; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Individualized action plan; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Individualized care plan; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Standardized reinforcement/motivational interviewing and action plan teach-back sessions; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Tele-home monitoring; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Coordinated and improved communication; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Priority access; Assigned to Arm(s): Case Management | Intervention Type: BEHAVIORAL; Name: Dictated patient summary; Assigned to Arm(s): Case Management, Usual care | Intervention Type: BEHAVIORAL; Name: in-hospital rehabilitation/self-management program; Assigned to Arm(s): Case Management, Usual care | Intervention Type: BEHAVIORAL; Name: Smoking cessation; Assigned to Arm(s): Case Management, Usual care | Intervention Type: BEHAVIORAL; Name: Action plan Respirologist; Assigned to Arm(s): Usual care | Intervention Type: BEHAVIORAL; Name: Web based self management materials; Assigned to Arm(s): Usual care
C: Arm Label: Activity-Self Management; Type: EXPERIMENTAL; Interventions: Behavioral: Self-Management and Motivational Interviewing | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Self-Management and Motivational Interviewing; Assigned to Arm(s): Activity-Self Management
D: 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

Answer: D