Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Moderate to severe COPD according to the recent GOLD guidelines
* Reduced exercise capacity during an incremental exercise test of less than 70% of predicted normal values

Exclusion Criteria:

* Lack of motivation to participate in the treatment program
* Other pathologic conditions unabling participation in the training program (e.g. coronary, orthopaedic, neurological or severe endocrine disorders)
* participation in other pulmonary rehabilitation projects
B: Inclusion Criteria:

Population to be studied

The study population consists of VA patients with COPD who receive some of their medical care at Veterans Affairs medical centers and were hospitalized for COPD in the last 12 months. To ensure that patients enrolled in the study receive regular care at the participating VA, we will include only patients enrolled in either the primary care or pulmonary clinic at the VA medical center and were seen at least once in the last year. This criterion should not significantly decrease the number of eligible patients because 90% of patients admitted for COPD in the VA had at least 1 outpatient visit to the VA primary care clinic in the year prior to their hospitalization based on data from the VA OPC in FY03.

Inclusion Criteria:

1. Diagnosis of COPD confirmed by all of the following:

   1. FEV1/FVC \< 0.70
   2. FEV1 \< 80%
   3. Age \> 40 years
   4. A current or past history of cigarette smoking (\> 10 pack-years)
2. COPD hospitalization in the previous year
3. Receives care at participating VA medical center

   1. Enrolled in either primary care or pulmonary clinic at the VA
   2. Seen at least once in the past year in either primary care or pulmonary clinic
4. No COPD exacerbations in last 4 weeks
5. English-speaking
6. Access to telephone

Exclusion Criteria:

1. Primary clinical diagnosis of asthma
2. Medical conditions affecting the ability to participate in the study such as:

   1. Comorbid illness likely to limit life expectancy \< 1 year
   2. Decompensated heart failure
   3. Dementia
   4. Uncontrolled psychiatric illness
3. Participation in another clinical intervention trial in the previous 30 days
C: Inclusion Criteria:

One or more of the following:

* Hospital admission for COPD within the prior year
* Unscheduled visit for COPD within the prior year
* Home oxygen use for COPD
* Systemic steroid use for COPD within the prior year
* Post bronchodilator FEV1 \< 70% predicted
* Post bronchodilator FEV1/FVC \< 70% predicted

Exclusion Criteria:

* Any unstable medical condition that would preclude effective participation in the study, or which would be expected to reduce life expectancy to \< 1 year
* Inability to contact patient by telephone
D: Inclusion Criteria:

* Diagnosis of COPD, clinically stable for 1 month;
* Spirometry results showing at least mild disease (FEV1/FVC \< 70% and FEV1 \< 80% predicted after bronchodilator);
* ADL limited by dyspnea;
* Ability to speak English and sign consent form;
* Actively use computer and the Internet;
* Maintain O2 saturation \> 85% on \< 6 L/min of nasal oxygen during the six minute walk;
* Understands and is able to rate shortness of breath during exercise

Exclusion Criteria:

* Active symptomatic illness other than COPD;
* Formal pulmonary rehabilitation training in the past 6 months

Answer: A